Careers

Join our team

Our team is smart, bold and innovative. Thinking about applying? You’re in the right place.

Culture

At RaNA, we are ONE. We’re diverse, yet united in our mission to change the treatment paradigm for patients living with genetic diseases. We stick to our values.

We work hand in hand with our leaders to encourage new ways of thinking.

In the seriousness of our mission, we also understand we are people and like to have fun together. From bonding during lunch to new discoveries in the lab that lead us that much closer to helping people, there’s always something to look forward to each day at RaNA. Our story is best told by the very people who live and breathe our science and mission every day: our fearless employees.

Quote-Amy

“The employees here are extremely intelligent and enthusiastic about our science, which makes coming into work every day fun and exciting.”

- Amy Iannelli, Manager of Finance and External Reporting

Quote-Jia

“I am empowered to make an impact here.”

- Jia Tay, Scientist

“I work with incredibly driven and intelligent individuals, who constantly challenge me and allow me to develop further as a scientist.”

- Elizabeth Wu, Research Associate

Quote-Elizabeth

“It’s all about the anticipation. Each day I wake up knowing we are one step closer to a breakthrough medicine.”

- John Androsavich, Senior Scientist

Quote-John

Opportunities

If you are interested in joining our RaNA team, please review the openings below and submit your resume to careers@ranarx.com with the job title in the subject line.

Associate Scientist, CMC

Lexington, MA

We are seeking a highly motivated and scientifically rigorous individual to join our team as an Associate Scientist.  The successful candidate will report to Senior Scientist, CMC. The position will focus on drug substance and drug product manufacture, regulatory and analytical support, including development, validation, and data review for drug substances and drug products.  The position will help develop and execute scalable and robust formulation processes for drug substance and drug product and help serve as the process knowledge link between Process Development and drug substance and drug product manufacturing.

Primary Responsibilities

  • Assist in coordinating technology transfer of mRNA and nanoparticle manufacturing processes
  • Design and conduct experiments to investigate the impact of formulation parameters on drug product processes
  • Identify solutions, including process analytical technologies, which lead to robust process control strategies
  • Provide technical support for scale-up and manufacturing issues, and develop solutions to improve process efficiency and product quality
  • Prepare technical reports and presentations that support scale-up activities and process improvements
  • Support and contribute to IND filings/regulatory documentation

Qualifications

  • A Bachelor’s or Master’s degree in Chemistry, Chemical engineering or Biochemistry is required
  • 3 – 6 years of experience working in a pharmaceutical or biotechnology company is required
  • Demonstrated experience in process development/scale-up of drug product formulation is required
  • A familiarity and hands-on experience with the development of novel drug carriers using nanoparticle formulations is required
  • Experience with analytical tools for release and characterization of drug product processes and drug products is required
  • Demonstrated ability to apply fundamental scientific and engineering skills to evaluation of processes and development of practical solutions to technical challenges is required
  • Must have experience working within a GMP pharmaceutical manufacturing unit operations, such as lyophilization, filtration and filling
  • Familiarity with cGMP, ICH and regulatory guidelines
  • Ability to partner with CROs/CMOs
  • Desire to work in a fast-paced environment
  • Excellent organizational and communication skills
  • Strong operational execution and problem-solving skills are desired
  • Desire to work in a fast-paced, deadline-driven environment
  • Excellent organizational and communication skills
  • Strong analytical and problem-solving skills

 

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

Director, Bioanalytical Development

Lexington, MA

We are seeking a highly motivated and scientifically rigorous individual to join our team as an Director, Bioanalytical Development. The successful candidate will report to to the Chief Scientific Officer and be an integral part of the Translational Development team. The Director of Bioanalytical Development is accountable for timely and effective Bioanalytical support for all programs in preclinical and clinical development. The incumbent provides leadership and oversight of the Bioanalytical group, as well as providing expertise in Regulatory aspects of Bioanalytical to project/program teams and RaNA management. The successful group leader is expected to maintain a lean, flat, consensus-driven team and to balance big picture, long-term and strategic considerations with tactical, detailed technical decision-making. This individual will be highly analytical, decisive, goal-oriented, and timeline sensitive while maintaining the highest of scientific and ethical standards.

The Director of Bioanalytical Development develops and implements strategic project/program plans and is responsible for technical oversight, design, outsourcing, validation (including CRO compliance audits), implementation and documentation for Regulatory submission purposes of all bioanalytical and immunogenicity assessment methods (eg, LC/MS, ISH, qPCR, EIispot, MSD to support our oligo and mRNA therapy programs at the preclinical and clinical stages. They will actively participates in project/program teams, as well as collaborating effectively with Discovery and  Delivery groups. The incumbent will establish and maintain high quality systems and procedures for outsourcing, managing and reporting regulated Bioanalytical programs, studies and other activities in support of RaNA portfolio programs and to provide submission-ready documentation for the Bioanalytical components of regulatory submissions. 

Primary Responsibilities

  • Leadership and oversight of the Bioanalytical Development
  • Provide high-level advice to project/program teams and RaNA management, including evaluation of conclusions and potential impact of study results on program and clinical/regulatory strategy
  • Review and approve Bioanalytical protocols, reports, associated summaries, sections and associated documentation, as well as abstracts/manuscripts for publication
  • Design, manage, analyze, review, summarize, interpret and report results of Bioanalytical validation and testing studies
  • Establish and maintain high quality systems for outsourcing, managing and reporting Bioanalytical methods and studies that meet both relevant regulatory authority guidelines/expectations and current industry best practices
  • Oversee the development and maintenance of a robust network of CRO and consultant relationships to ensure scalable, flexible capacity capable of responding rapidly to dynamic portfolio support needs at all stages of development
  • Maintain up-to-date Bioanalytical Development plans (linked to overall Translational Development and Program Management plans) for all projects/programs, including listings of studies, timelines, status and costs; update and refine as necessary
  • Oversee systems, process implementation and training; periodically review and revise procedures to ensure appropriateness of current practices, adherence to quality principles and GLP/GCP and provide appropriate training and mentorship of staff
  • Support the budget planning process by preparing estimates for resource requirements, schedules, costs and capital equipment/services, including budget forecasts and re-forecasts for Bioanalytical programs, as required by Project/Program management and Finance
  • Provide scientific/technical due diligence support for Business Development activities as required
  • Prepare for and participate in regulatory agency interactions

Qualifications

  • PhD in a related subject
  • 10+ years of experience working in a Bioanalytical role within the pharmaceutical or biotechnology industry is required
  • Hands-on experience in all aspects of Bioanalytical assay and study design and conduct in all relevant formats
  • Experience representing function to regulatory agencies in support of submissions at all stages of development, ie, IND/CTA, CTD, IMPD, MAA/NDA/BLA/JNDA
  • Demonstrated knowledge of regulatory requirements and expectations for Bioanalytical packages to support first in human, clinical development, and product registration, including thorough knowledge of GLP, GCP, ICH and other applicable guidelines
  • Extensive experience in the outsourcing and external oversight of regulated (GLP, GCP) Bioanalytical studies conducted by qualified suppliers
  • Experience with both large and small molecule, including biologic, nucleic acid, gene and cell-based therapies is highly desirable
  • Experience in providing formal scientific/technical due diligence support for Business Development activities is required
  • Evidence of leadership within the industry, eg, such as through peer-reviewed publications or as a participant on expert panels or working groups, is preferred.
  • Desire to work in a fast-paced environment
  • Excellent organizational and communication skills
  • Strong analytical and problem-solving skills

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

Director, Pharmacology

Lexington, MA

 We are seeking a highly motivated and scientifically rigorous individual to join our team as a Director of Pharmacology (depending upon commensurate experience). The successful candidate will report to the Head of Translational Development (interim reporting to Chief Scientific Officer) and be an integral part of the Translational Development team. This position offers opportunities to provide leadership and oversight of the nonclinical Pharmacology group and provide high-level advice to project/program teams and RaNA management. The successful candidate will be responsible for timely and effective pharmacology support for all programs in preclinical or clinical development.

Primary Responsibilities

  • Leadership and oversight of the nonclinical Pharmacology group
  • Provide high-level advice to project/program teams and RaNA management, including evaluation of conclusions and potential impact of study results on program and clinical/regulatory strategy
  • Review and approve Pharmacology study protocols, reports, associated summaries, sections and associated documentation, as well as abstracts/manuscripts for publication
  • Design, manage, analyze, review, summarize, interpret and report results of Pharmacology studies
  • Establish and maintain high quality systems for outsourcing, managing and reporting Pharmacology studies that meet both relevant regulatory authority guidelines/expectations and current industry best practices
  • Oversee the development and maintenance of a robust network of CRO and consultant relationships to ensure scalable, flexible capacity capable of responding rapidly to dynamic portfolio support needs at all stages of development
  • Responsible for analysis and interpretation of Pharmacology data with overall responsibility to ensure that sufficient pre/nonclinical data and knowledge supporting primary and secondary pharmacology, mechanism of action (MoA), exposure-response (PK-PD), etc. has been generated and appropriately documented to underwrite safe and effective human administration
  • Maintain up-to-date Pharmacology plans (linked to overall Translational Development & Program Management plans) for all projects/programs, including listings of studies, timelines, status and costs; update and refine as necessary
  • Oversee systems, process implementation and training; periodically review and revise procedures to ensure appropriateness of current practices, adherence to quality principles and GxPs and provide appropriate training and mentorship of staff
  • Support the budget planning process by preparing estimates for resource requirements, schedules, costs and capital equipment/ services, including budget forecasts and re-forecasts for Pharmacology programs, as required by Project/Program management and Finance
  • Provide scientific/technical due diligence support for Business Development activities as required
  • Prepare for and participate in regulatory agency interactions

Qualifications 

  • PhD in a related field is required
  • 10+ years industry related experience in regulatory Pharmacology working within the pharmaceutical or biotechnology industry is required
  • Demonstrated success of global regulatory requirements and expectations for Pharmacology packages to support first in human, clinical development, and product registration, including thorough knowledge of GLP, GCP, ICH and other applicable global guidelines
  • Hands-on experience in all aspects of Pharmacology study design & conduct
  • Experience with outsourcing and external oversight of Pharmacology studies conducted by qualified suppliers
  • Experience with both large & small molecule, including biologic, nucleic acid, gene and cell-based therapies is highly desirable
  • Experience in providing formal scientific/technical due diligence support for Business Development activities is required
  • Evidence of leadership within the industry, eg such as through peer-reviewed publications or as a participant on expert panels or working groups, is preferred
  • Fluency in written and spoken English is required
  • Desire to work in a fast-paced environment
  • Excellent organizational and communication skills
  • Strong analytical and problem-solving skills

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

Associate Director/Director, Pharmacokinetics & Drug Metabolism (PKDM)

Lexington, MA

We are seeking highly motivated and scientifically rigorous individual to join RaNA and lead our PKDM efforts. The successful candidate will report to the Chief Scientific Officer and will be an integral part of the Research and Development team.

Summary of Role

The Associate Director or Director of Pharmacokinetics and Drug Metabolism (PKDM) is responsible for providing PKDM strategy, expertise, representation and resources to all program teams and RaNA management across all therapeutic areas and stages of development.  S/he will provide leadership and oversight of the PKDM group and will work closely with Discovery, Chemistry, Regulatory and Clinical colleagues to generate and integrate PK and ADME data leading to the estimation of safe and efficacious first in human clinical dose and regimen for novel therapeutics, as well as predicted clinical PK and PK/PD profiles and optimal posology. In addition, the PKDM organization will be responsible for design, analysis and reporting for all phase-appropriate and registration-enabling studies (e.g., bioavailability, ADME, bioequivalence, DDI, food-effect). The successful group leader is expected to maintain a flat, consensus-driven team and to balance big picture, long-term and strategic considerations with tactical, detailed technical aspects in approaching and dealing with program-related PKDM issues. This individual will be highly analytical, decisive, goal-oriented, and timeline sensitive while maintaining the highest of scientific and ethical standards. The Associate Director or Director of PKDM develops and implements strategic plans for preclinical and clinical pharmacokinetics and actively participates in program teams, providing expert representation to global regulatory agencies as well as collaborating with R&D leadership and assisting in the identification of new business initiatives and in-licensing opportunities. The successful candidate will establish and maintain appropriate quality systems and procedures for outsourcing, managing and reporting for PKDM studies and other activities in support of RaNA portfolio programs, and provide submission-ready documentation for the PKDM components of regulatory submissions.

Key Competencies

  • A broad understanding of the drug development process (both large & small molecule) and the ability to provide expert guidance in designing and implementing nonclinical PKDM studies and development programs for biopharmaceuticals including protein therapies, antibodies, oligonucleotides and small-molecule therapeutics.
  • Demonstrated knowledge of global regulatory requirements and expectations for nonclinical and clinical PKDM packages to support first in human, clinical development, and product registration, including thorough knowledge of GLP, GCP, ICH and other applicable global guidelines.
  • Ability to analyze, interpret and document nonclinical and clinical pharmacokinetic/ADME and PK/PD data with overall responsibility to ensure that sufficient preclinical PK/ADME and PK/PD knowledge exists to underwrite safe and effective human administration.
  • Experience within a team environment as both a member and a leader with strong organizational and interpersonal skills, including exceptional oral and written communication skills with a demonstrated ability to write protocols, nonclinical/clinical study reports and scientific peer-reviewed publications.
  • Ability to influence through effective communication, respectful challenge, and persuasion across the Research and Development organization is essential.
  • Ability to effectively represent the Company to key external stakeholders, effectively engage and present to staff at all levels, including senior management and technical and business experts clearly and at the appropriate level of detail in representing strategy, results and implications.
  • Demonstrate and maintain comprehensive cross-functional and industry perspective, judgement and ability to apply understanding to individual projects and programs.

Requirements

  • PhD in a related subject.
  • 8-10+ years industry-related experience in regulatory PKDM working within the biotechnology or pharmaceutical industry, including previous work with nucleic acid therapeutics.
  • Extensive training in pharmacokinetic analysis and biostatistics, including construction of PK and PK/PD models, simulation, and prediction of first-in-human and human equivalent doses is required.
  • Hands-on experience in all aspects of PKDM study conduct, including: study design, execution interpretation and reporting, in vitro/in vivo PK & PD and ADME, methods, animal models, inter-species scaling, advanced data analysis, modeling and simulation, reporting and compliance.
  • Experience authoring relevant sections of regulatory documents and providing expert representation to global regulatory agencies in support of submissions at all stages of development, ie, IND/CTA, CTD, IMPD, MAA/NDA/BLA/JNDA.
  • Extensive experience in the outsourcing and external oversight of PKDM studies conducted by qualified suppliers.
  • Experience in providing formal scientific/technical due diligence support for Business Development activities is required.
  • Evidence of leadership within the industry, eg such as through peer-reviewed publications or as a participant on expert panels or working groups, is preferred.
  • Must be motivated, creative, energetic, resourceful and adaptable, responding constructively to challenging new ideas, information, situations or criticism.
  • Must be able to balance big picture thinking with fine detail level analysis and have demonstrated ability in problem solving as applied to drug development and program/functional management.
  • Fluency in written and spoken English is required.
  • Domestic and occasional international travel required.

Associate Director/Director, Toxicology

Lexington, MA

We are seeking highly motivated and scientifically rigorous individual to join RaNA and lead our Toxicology efforts.  The successful candidate will report to the Head of Translational Development and will be an integral part of the Research and Development team.

Summary of Role

The Head of Toxicology is responsible for providing strategy, expertise, representation and resources for assessment of drug safety to all program teams and RaNA management across all therapeutic areas and stages of development. S/he will provide leadership and oversight of the Toxicology group, and will work closely with Discovery, Chemistry, Regulatory and Clinical colleagues to assess the safety profiles of optimized leads and early development candidates and determine clinical safe starting dose, dose range, safety margins and anticipated safety parameters to be monitored during clinical development.  In addition, the Toxicology organization will be responsible for design and conduct of all phase-appropriate and registration-enabling studies (e.g., DART, safety pharmacology, carcinogenicity). The successful group leader is expected to maintain a flat, consensus-driven team and to balance big picture, long-term and strategic considerations with tactical, detailed technical aspects in approaching and dealing with project/program or product-related drug safety issues. This individual will be highly analytical, decisive, goal-oriented, and timeline sensitive while maintaining the highest of scientific and ethical standards. The Head of Toxicology develops and implements strategic plans for nonclinical drug safety assessment and actively participates in program teams, providing expert representation to global regulatory agencies as well as collaborating with R&D leadership and assisting in the identification of new business initiatives and in-licensing opportunities. The successful candidate will establish and maintain high quality systems and procedures for outsourcing, managing and reporting regulatory toxicology programs, studies and other activities in support of RaNA portfolio programs and to provide submission-ready documentation for the toxicology components of regulatory submissions.

Key Competencies

  • A broad understanding of the drug development process (both large & small molecule) and the ability to provide expert guidance in designing and implementing nonclinical Toxicology and Safety Pharmacology studies and development programs for biopharmaceuticals including protein therapies, antibodies, oligonucleotides and small-molecule therapeutics.
  • Ability to analyze, interpret and document nonclinical Toxicology data with overall responsibility to ensure that sufficient preclinical safety data and knowledge exist to underwrite safe and effective human administration.
  • Experience within a team environment as both a member and a leader with strong organizational and interpersonal skills, including exceptional oral and written communication skills with a demonstrated ability to write protocols, nonclinical/clinical study reports and scientific peer-reviewed publications.
  • Ability to influence through effective communication, respectful challenge, and persuasion across the Research and development organization is essential.
  • Ability to effectively represent the Company to key external stakeholders, effectively engage and present to staff at all levels, including senior management and technical and business experts clearly and at the appropriate level of detail in representing strategy, results and implications.
  • Demonstrate and maintain comprehensive cross-functional and industry perspective, judgement and ability to apply understanding to individual projects and programs.

Requirements

  • PhD in a related subject, with DABT certification.
  • 10+ years industry-related experience in regulatory Toxicology working within the biotechnology or pharmaceutical industry, including previous work with nucleic acid therapeutics.
  • Hands-on experience in all aspects of Toxicology study conduct including general, genetic, developmental and reproductive toxicology, carcinogenicity, toxicokinetics, and safety pharmacology and environmental risk assessment experience.
  • Demonstrated knowledge of global regulatory requirements and expectations for nonclinical safety assessment packages to support first in human, clinical development, and product registration, including thorough knowledge of GLP, GCP, ICH and other applicable global guidelines.
  • Experience authoring relevant sections of regulatory documents and providing expert representation to global regulatory agencies in support of submissions at all stages of development, ie, IND/CTA, CTD, IMPD, MAA/NDA/BLA/JNDA.
  • Extensive experience in the outsourcing and external oversight of nonclinical Toxicology studies conducted by qualified suppliers.
  • Experience in providing formal scientific/technical due diligence support for Business Development activities is required.
  • Evidence of leadership within the industry, eg such as through peer-reviewed publications or as a participant on expert panels or working groups, is preferred.
  • Must be able to balance big picture thinking with fine detail level analysis and have demonstrated ability in problem solving as applied to drug development and program/functional management.
  • Must be motivated, creative, energetic, resourceful and adaptable, responding constructively to challenging new ideas, information, situations or criticism.
  • Fluency in written and spoken English is required.
  • Domestic and occasional international travel required.

Scientist, mRNA Discovery

Lexington, MA

We are seeking a highly motivated and scientifically rigorous individual to join our team as an RNA Scientist in our Discovery group. This individual will demonstrate their leadership abilities via a thorough understanding of nucleic acid analytics, characterization, and development. They will work collaboratively within the group and with interdisciplinary teams, as well as building relationships externally with collaborators, CROs, CMOs, etc. There are several innovative projects that are ongoing, so we are looking for an exceptional scientist with either an MS or PhD (and accompanying industry experience) that has the proven ability to manage their time effectively.

Primary Responsibilities

  • Drive novel nucleic acid synthesis and structural characterization and applications towards in vivo protein production
  • Support mRNA batch production needs across multiple disease areas
  • Develop innovative assays for multiple lead programs as well as new discovery targets with focus on enzyme activity, identification, kinetics
  • Lead RNA/enzyme analytical discovery for mRNA platform with focus on characterization, design, execution and development of current and novel assays
  • Provide support for drug substance process development
  • Support and/or manage outside relationships with CROs with focus on assay development, technology transfer and troubleshooting for efficient completion of qualification/validation of all necessary assays to support CMC efforts
  • Build upon group’s instrumentational expertise and provide analytical insight across disciplines for MRT platform in a collaborative effort
  • Prepare technical reports and presentations for clear communication of scientific findings across interdisciplinary teams

Qualifications

M.S and 8+ years of experience in RNA Biology and Analytics (mixed with enzyme/protein experience)

OR

Ph.D. and 1-3+ years of experience in RNA Biology and Analytics (mixed with enzyme/protein experience)

  • Support mRNA batch synthesis and creation/characterization of novel synthetic constructs
  • Direct experience using chromatographic methods (HPLC/UPLC/AKTA), MS, gel electrophoresis, fragment analyzer, etc. Hands-on experience with LC-MS a plus
  • Experience with RNA ligation and reaction optimization is highly desired
  • Hands-on experience with isolation, characterization, quantification and handling of various nucleic acids (DNA, RNA, etc) is mandatory.  Messenger RNA (mRNA) experience would be given extreme preference
  • Analytical expertise (methods, assay development, troubleshooting) around RNA-based therapeutics is mandatory
  • Strong knowledge and execution of enzymatic assay development (ELISA, enzyme activity, western blot, silver stain, etc.) for protein detection characterization and quantification is imperative for success
  • Demonstrated record of successful in vitro/in vivo analysis supporting lead programs including proper RNA handling, tissue handling, protein/RNA isolation, etc. would be advantageous
  • Previous record of working with outside CRO/CMOs for technology transfer, guidance and troubleshooting is highly desired
  • Demonstrated track-record of progressing multiple projects forward under strict timelines
  • Desire to work in a fast-paced environment
  • Excellent organizational and communication skills
  • Strong analytical and problem-solving skills

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

Scientist, Drug Delivery

Lexington, MA

We are seeking a highly motivated and scientifically rigorous individual to join our team as a Scientist.   The successful candidate will report to the Associate Director/Group Leader and be an integral part of the MRT Drug Delivery team.  This position offers opportunities to discover, formulate and create leading mRNA formulations for the treatment of a wide array of genetic diseases.

The successful candidate will be responsible for supporting key formulation development for our MRT platform encompassing in vitro/in vivo mRNA formulation screening, nanoparticle design and characterization, new delivery modalities and applications as well as other critical responsibilities. This Scientist will demonstrate leadership via a thorough understanding of nucleic acid delivery and characterization. They will work collaboratively within the MRT group as well as within interdisciplinary teams, while simultaneously building relationships with outside collaborators, CROs, and/or CMOs.

Primary Responsibilities 

  • Conduct laboratory formulation development of mRNA drug targets entailing: production of LNP & polymer-based nanoparticles for invitro/in vivo studies
  • Application of knowledge towards formulation optimization for enhanced cellular uptake, endosomal escape, biodegradation and characterization
  • Focus on alternate routes of administration including local delivery, targeting, etc.
  • Develop stabilized formulations, lyophilization, improved thermal properties, etc.
  • Work closely with select CROs with focus on in vivo studies, drug carrier design/development, assay development
  • Prepare technical reports and presentations for clear communication of scientific findings across interdisciplinary teams
  • Manages time effectively demonstrating ability to perform multiple projects at one time

Qualifications

  • Ph.D. in Chemistry, Chemical engineering or Biochemistry
  • 1-3 years of industrial experience preferred
  • Demonstrated success in nucleic acid delivery and the development of novel drug carriers with hands-on experience in lipid nanoparticle (LNP) formulations, polymer-based nanoparticles & characterization (required)
  • Direct experience with messenger RNA encapsulation/quantification/characterization/handling is preferred
  • Working knowledge of organic chemistry and its applications to drug delivery (preferred)
  • Demonstrated thorough understanding of intracellular pathways, biodistribution parameters, kinetics, etc.
  • Previous experience designing successful drug products for various routes of administration (subcutaneous, intramuscular, pulmonary, GI, CNS, etc.)
  • Familiarity with lyophilization theory and techniques
  • Strong disposition for analytics (QC, methods, assay development)
  • Demonstrated experience in working with outside CROs/CMOs
  • Desire to work in a fast-paced environment
  • Excellent organizational and communication skills
  • Strong analytical and problem-solving skills

 RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

Project Manager, CMC

Lexington, MA

We are seeking a highly motivated and organized individual to join our team as a Project Manager.   The successful candidate will report to the Vice President of Manufacturing and be an integral part of the CMC team.  This position offers opportunities to work with multiple external CROs and CMOs in addition to the RaNA Therapeutics team.  The successful candidate will be responsible for management of multiple external CMC-related projects.

Primary Responsibilities

  • Manage CMC projects outsourced to multiple CROs / CMOs. Collaborate with internal and external teams to set priorities, plan activities, monitor progress, make decisions, resolve issues and identify risks and mitigation plans.
  • Track timelines, milestones and deliverables for outsourced projects to provide input into overarching program plan.
  • Manage inventory of multiple raw materials required for drug substance and drug product production. Coordinate with multiple vendors to order required raw materials and monitor outstanding deliveries.
  • Review and approve project/product related documentation including protocols, reports, procedures and specifications.
  • Assist in compilation of CMC information to support IND applications.
  • Assist in the development of new contracts with external CROs / CMOs. Track invoices against purchase orders.  Assist with budget planning and development.

Qualifications

  • Bachelor’s or Master’s degree in life sciences or engineering.
  • 5-8 years (Bachelor’s) / 3-5 years (Master’s) experience in a similar position, 5-10 total years’ experience in the biotechnology / pharmaceutical industry.
  • Demonstrated success in managing multiple projects effectively.
  • Ability to effectively represent the Company to external CROs and CMOs.
  • Knowledge of product development process including typical Chemistry, Manufacturing and Controls (CMC) activities.
  • Experience with analytical method development and qualification, process development, and cGMP manufacturing and release.
  • Desire to work in a fast-paced environment.
  • Excellent organizational and communication skills.
  • PMP certification desirable.

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

Associate Scientist, Process Development & Biological Characterization

Lexington, MA

We are seeking a highly motivated and scientifically rigorous individual to join our team as an Associate Scientist, mRNA Process Development and Biological Characterization. The successful candidate will report to the Associate Director/Group Leader and be an integral part of the MRT team.  This position offers opportunities to discover, create leading mRNA production processes providing crucial drug substance material applicable for the treatment of a wide array of genetic diseases.  The successful candidate will be responsible for supporting mRNA process development for our MRT platform encompassing the development of the largest scale mRNA production in the industry, optimization of current small scale mRNA batch production, full characterization of drug substance material as well as other critical responsibilities.

Primary Responsibilities

  • Support mRNA process development efforts for multiple mRNA drug targets entailing: large-scale batch production, batch record execution/maintenance, optimization of mRNA processes (enzymatic/physical/analytical)
  • Provide accurate and reproducible execution of analytical characterization for full release panel for mRNA drug substance
  • Conduct biological assays such as ELISA, western blot, gel electrophoresis supporting lead programs
  • Prepare technical reports and makes recommendations based on research outcomes

Qualifications

  • M.S. in Biology, Biochemistry, Engineering
  • 6-10 years of industrial experience preferred
  • Demonstrated success in nucleic acid synthesis/handling(RNase-Free)/application with hands-on experience in messenger RNA production/characterization (required)
  • Further experience with process development/scale-up and a working knowledge of batch record documentation is highly desired
  • Familiarity with GMP operations is preferred
  • Strong disposition for analytics (QC, methods, assay development)
  • Ability to conduct routine biological assays including ELISA, western blot, silver stain, gel electrophoresis, etc. would be preferred
  • Handling/analysis of in vitro/in vivo tissue and serum samples is advantageous
  • Desire to work in a fast-paced environment
  • Excellent organizational and communication skills
  • Strong analytical and problem-solving skills

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

Principal Development Scientist, Manufacturing Sciences & Technology

Lexington, MA

We are seeking a highly motivated and scientifically rigorous individual to join our team as a Principal Development Scientist. The successful candidate will report to the Vice President, Manufacturing and be an integral part of the MRT team. The position will focus on drug substance and drug product manufacture, drug formulation, regulatory and analytical support, including development, validation, and data review for drug substances and drug products.

Will also provide technical support to the MRT team for the pharmaceutical development of RaNA’s Messenger RNA Therapeutics lead candidates.  The position will help develop scalable and robust formulation processes for drug substance and drug product and serve as the process knowledge link between Process Development and drug substance and drug product manufacturing.

Primary Responsibilities

80%

  • Provide technical leadership for drug product development and tech transfer activities.
  • Author/review development documents and support IND regulatory submissions
  • Represent within cross functional project teams including process development, CMC and tech transfer teams
  • Will provide support in laboratory to Process Development team when needed as it relates to manufacture of DS or DP.          
  • Manages and oversees the development of drug substances and drug formulations and/or transfer of development activities with RaNA contractors.
  • Provides technical input for selecting external RaNA contractors as well as managing the day-to-day contractor activities with MRT Program Managers.
  • Leads drug /device compatibility assessment activities.
  • Works closely with GMP manufacturers of drug products and drug substances.
  • Writes/reviews protocols and performs batch record review for manufacturer of drug substances and drug products.
  • Writes/reviews analytical method protocols and stability protocols.
  • Writes CMC and drug/device compatibility documents to support IND filings.
  • Provides any necessary support to line manager as required

20%

  • Assists in the review and evaluation of CMC documents during a due diligence exercise.
  • Uses DOE and QbD principles in developing robust API and Finished Product manufacturing processes

Key Skills and Competencies

  • The principal development scientist position will work closely with groups within MRT including Process and Analytical Development as well as external contract organizations, and participate /lead tech transfer teams and work with CMO on cGMP manufacture and release of drug product.
  • Extensive experience and demonstrated track record in biopharmaceutical development including but not limited to formulation development, drug product development, drug product process characterization and validation.
  • In-depth understanding of nucleic acid drug development, formulation, delivery systems and drug/device characterization.
  • Must be well-organized and self-motivated, and possess an independent work style.
  • Ability to lead effectively and concurrently on multiple projects in a goal-oriented, timeline-driven, and dynamic work environment while ensuring quality and accuracy.
  • Proactively identify potential issues and develop creative solutions to technical problems to keep projects on schedule.
  • Excellent interpersonal skills with the ability to interact professionally and effectively with peers, management, and leadership both within and outside RaNA.

Qualifications

  • Ph.D. degree in pharmaceutical chemistry, biochemistry, engineering or related disciplines.
  • Minimum of 8 years of experience in pharmaceutical development and manufacturing of nucleic acid-based therapeutics.
  • Experience with PD/mfg, release testing, formulation development, drug/device characterization

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

Lexington, MA

We are seeking a highly motivated and scientifically rigorous individual to join our team as an Associate Scientist.  The successful candidate will report to Senior Scientist, CMC. The position will focus on drug substance and drug product manufacture, regulatory and analytical support, including development, validation, and data review for drug substances and drug products.  The position will help develop and execute scalable and robust formulation processes for drug substance and drug product and help serve as the process knowledge link between Process Development and drug substance and drug product manufacturing.

Primary Responsibilities

  • Assist in coordinating technology transfer of mRNA and nanoparticle manufacturing processes
  • Design and conduct experiments to investigate the impact of formulation parameters on drug product processes
  • Identify solutions, including process analytical technologies, which lead to robust process control strategies
  • Provide technical support for scale-up and manufacturing issues, and develop solutions to improve process efficiency and product quality
  • Prepare technical reports and presentations that support scale-up activities and process improvements
  • Support and contribute to IND filings/regulatory documentation

Qualifications

  • A Bachelor’s or Master’s degree in Chemistry, Chemical engineering or Biochemistry is required
  • 3 – 6 years of experience working in a pharmaceutical or biotechnology company is required
  • Demonstrated experience in process development/scale-up of drug product formulation is required
  • A familiarity and hands-on experience with the development of novel drug carriers using nanoparticle formulations is required
  • Experience with analytical tools for release and characterization of drug product processes and drug products is required
  • Demonstrated ability to apply fundamental scientific and engineering skills to evaluation of processes and development of practical solutions to technical challenges is required
  • Must have experience working within a GMP pharmaceutical manufacturing unit operations, such as lyophilization, filtration and filling
  • Familiarity with cGMP, ICH and regulatory guidelines
  • Ability to partner with CROs/CMOs
  • Desire to work in a fast-paced environment
  • Excellent organizational and communication skills
  • Strong operational execution and problem-solving skills are desired
  • Desire to work in a fast-paced, deadline-driven environment
  • Excellent organizational and communication skills
  • Strong analytical and problem-solving skills

 

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

Lexington, MA

We are seeking a highly motivated and scientifically rigorous individual to join our team as an Director, Bioanalytical Development. The successful candidate will report to to the Chief Scientific Officer and be an integral part of the Translational Development team. The Director of Bioanalytical Development is accountable for timely and effective Bioanalytical support for all programs in preclinical and clinical development. The incumbent provides leadership and oversight of the Bioanalytical group, as well as providing expertise in Regulatory aspects of Bioanalytical to project/program teams and RaNA management. The successful group leader is expected to maintain a lean, flat, consensus-driven team and to balance big picture, long-term and strategic considerations with tactical, detailed technical decision-making. This individual will be highly analytical, decisive, goal-oriented, and timeline sensitive while maintaining the highest of scientific and ethical standards.

The Director of Bioanalytical Development develops and implements strategic project/program plans and is responsible for technical oversight, design, outsourcing, validation (including CRO compliance audits), implementation and documentation for Regulatory submission purposes of all bioanalytical and immunogenicity assessment methods (eg, LC/MS, ISH, qPCR, EIispot, MSD to support our oligo and mRNA therapy programs at the preclinical and clinical stages. They will actively participates in project/program teams, as well as collaborating effectively with Discovery and  Delivery groups. The incumbent will establish and maintain high quality systems and procedures for outsourcing, managing and reporting regulated Bioanalytical programs, studies and other activities in support of RaNA portfolio programs and to provide submission-ready documentation for the Bioanalytical components of regulatory submissions. 

Primary Responsibilities

  • Leadership and oversight of the Bioanalytical Development
  • Provide high-level advice to project/program teams and RaNA management, including evaluation of conclusions and potential impact of study results on program and clinical/regulatory strategy
  • Review and approve Bioanalytical protocols, reports, associated summaries, sections and associated documentation, as well as abstracts/manuscripts for publication
  • Design, manage, analyze, review, summarize, interpret and report results of Bioanalytical validation and testing studies
  • Establish and maintain high quality systems for outsourcing, managing and reporting Bioanalytical methods and studies that meet both relevant regulatory authority guidelines/expectations and current industry best practices
  • Oversee the development and maintenance of a robust network of CRO and consultant relationships to ensure scalable, flexible capacity capable of responding rapidly to dynamic portfolio support needs at all stages of development
  • Maintain up-to-date Bioanalytical Development plans (linked to overall Translational Development and Program Management plans) for all projects/programs, including listings of studies, timelines, status and costs; update and refine as necessary
  • Oversee systems, process implementation and training; periodically review and revise procedures to ensure appropriateness of current practices, adherence to quality principles and GLP/GCP and provide appropriate training and mentorship of staff
  • Support the budget planning process by preparing estimates for resource requirements, schedules, costs and capital equipment/services, including budget forecasts and re-forecasts for Bioanalytical programs, as required by Project/Program management and Finance
  • Provide scientific/technical due diligence support for Business Development activities as required
  • Prepare for and participate in regulatory agency interactions

Qualifications

  • PhD in a related subject
  • 10+ years of experience working in a Bioanalytical role within the pharmaceutical or biotechnology industry is required
  • Hands-on experience in all aspects of Bioanalytical assay and study design and conduct in all relevant formats
  • Experience representing function to regulatory agencies in support of submissions at all stages of development, ie, IND/CTA, CTD, IMPD, MAA/NDA/BLA/JNDA
  • Demonstrated knowledge of regulatory requirements and expectations for Bioanalytical packages to support first in human, clinical development, and product registration, including thorough knowledge of GLP, GCP, ICH and other applicable guidelines
  • Extensive experience in the outsourcing and external oversight of regulated (GLP, GCP) Bioanalytical studies conducted by qualified suppliers
  • Experience with both large and small molecule, including biologic, nucleic acid, gene and cell-based therapies is highly desirable
  • Experience in providing formal scientific/technical due diligence support for Business Development activities is required
  • Evidence of leadership within the industry, eg, such as through peer-reviewed publications or as a participant on expert panels or working groups, is preferred.
  • Desire to work in a fast-paced environment
  • Excellent organizational and communication skills
  • Strong analytical and problem-solving skills

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

Lexington, MA

 We are seeking a highly motivated and scientifically rigorous individual to join our team as a Director of Pharmacology (depending upon commensurate experience). The successful candidate will report to the Head of Translational Development (interim reporting to Chief Scientific Officer) and be an integral part of the Translational Development team. This position offers opportunities to provide leadership and oversight of the nonclinical Pharmacology group and provide high-level advice to project/program teams and RaNA management. The successful candidate will be responsible for timely and effective pharmacology support for all programs in preclinical or clinical development.

Primary Responsibilities

  • Leadership and oversight of the nonclinical Pharmacology group
  • Provide high-level advice to project/program teams and RaNA management, including evaluation of conclusions and potential impact of study results on program and clinical/regulatory strategy
  • Review and approve Pharmacology study protocols, reports, associated summaries, sections and associated documentation, as well as abstracts/manuscripts for publication
  • Design, manage, analyze, review, summarize, interpret and report results of Pharmacology studies
  • Establish and maintain high quality systems for outsourcing, managing and reporting Pharmacology studies that meet both relevant regulatory authority guidelines/expectations and current industry best practices
  • Oversee the development and maintenance of a robust network of CRO and consultant relationships to ensure scalable, flexible capacity capable of responding rapidly to dynamic portfolio support needs at all stages of development
  • Responsible for analysis and interpretation of Pharmacology data with overall responsibility to ensure that sufficient pre/nonclinical data and knowledge supporting primary and secondary pharmacology, mechanism of action (MoA), exposure-response (PK-PD), etc. has been generated and appropriately documented to underwrite safe and effective human administration
  • Maintain up-to-date Pharmacology plans (linked to overall Translational Development & Program Management plans) for all projects/programs, including listings of studies, timelines, status and costs; update and refine as necessary
  • Oversee systems, process implementation and training; periodically review and revise procedures to ensure appropriateness of current practices, adherence to quality principles and GxPs and provide appropriate training and mentorship of staff
  • Support the budget planning process by preparing estimates for resource requirements, schedules, costs and capital equipment/ services, including budget forecasts and re-forecasts for Pharmacology programs, as required by Project/Program management and Finance
  • Provide scientific/technical due diligence support for Business Development activities as required
  • Prepare for and participate in regulatory agency interactions

Qualifications 

  • PhD in a related field is required
  • 10+ years industry related experience in regulatory Pharmacology working within the pharmaceutical or biotechnology industry is required
  • Demonstrated success of global regulatory requirements and expectations for Pharmacology packages to support first in human, clinical development, and product registration, including thorough knowledge of GLP, GCP, ICH and other applicable global guidelines
  • Hands-on experience in all aspects of Pharmacology study design & conduct
  • Experience with outsourcing and external oversight of Pharmacology studies conducted by qualified suppliers
  • Experience with both large & small molecule, including biologic, nucleic acid, gene and cell-based therapies is highly desirable
  • Experience in providing formal scientific/technical due diligence support for Business Development activities is required
  • Evidence of leadership within the industry, eg such as through peer-reviewed publications or as a participant on expert panels or working groups, is preferred
  • Fluency in written and spoken English is required
  • Desire to work in a fast-paced environment
  • Excellent organizational and communication skills
  • Strong analytical and problem-solving skills

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

Lexington, MA

We are seeking highly motivated and scientifically rigorous individual to join RaNA and lead our PKDM efforts. The successful candidate will report to the Chief Scientific Officer and will be an integral part of the Research and Development team.

Summary of Role

The Associate Director or Director of Pharmacokinetics and Drug Metabolism (PKDM) is responsible for providing PKDM strategy, expertise, representation and resources to all program teams and RaNA management across all therapeutic areas and stages of development.  S/he will provide leadership and oversight of the PKDM group and will work closely with Discovery, Chemistry, Regulatory and Clinical colleagues to generate and integrate PK and ADME data leading to the estimation of safe and efficacious first in human clinical dose and regimen for novel therapeutics, as well as predicted clinical PK and PK/PD profiles and optimal posology. In addition, the PKDM organization will be responsible for design, analysis and reporting for all phase-appropriate and registration-enabling studies (e.g., bioavailability, ADME, bioequivalence, DDI, food-effect). The successful group leader is expected to maintain a flat, consensus-driven team and to balance big picture, long-term and strategic considerations with tactical, detailed technical aspects in approaching and dealing with program-related PKDM issues. This individual will be highly analytical, decisive, goal-oriented, and timeline sensitive while maintaining the highest of scientific and ethical standards. The Associate Director or Director of PKDM develops and implements strategic plans for preclinical and clinical pharmacokinetics and actively participates in program teams, providing expert representation to global regulatory agencies as well as collaborating with R&D leadership and assisting in the identification of new business initiatives and in-licensing opportunities. The successful candidate will establish and maintain appropriate quality systems and procedures for outsourcing, managing and reporting for PKDM studies and other activities in support of RaNA portfolio programs, and provide submission-ready documentation for the PKDM components of regulatory submissions.

Key Competencies

  • A broad understanding of the drug development process (both large & small molecule) and the ability to provide expert guidance in designing and implementing nonclinical PKDM studies and development programs for biopharmaceuticals including protein therapies, antibodies, oligonucleotides and small-molecule therapeutics.
  • Demonstrated knowledge of global regulatory requirements and expectations for nonclinical and clinical PKDM packages to support first in human, clinical development, and product registration, including thorough knowledge of GLP, GCP, ICH and other applicable global guidelines.
  • Ability to analyze, interpret and document nonclinical and clinical pharmacokinetic/ADME and PK/PD data with overall responsibility to ensure that sufficient preclinical PK/ADME and PK/PD knowledge exists to underwrite safe and effective human administration.
  • Experience within a team environment as both a member and a leader with strong organizational and interpersonal skills, including exceptional oral and written communication skills with a demonstrated ability to write protocols, nonclinical/clinical study reports and scientific peer-reviewed publications.
  • Ability to influence through effective communication, respectful challenge, and persuasion across the Research and Development organization is essential.
  • Ability to effectively represent the Company to key external stakeholders, effectively engage and present to staff at all levels, including senior management and technical and business experts clearly and at the appropriate level of detail in representing strategy, results and implications.
  • Demonstrate and maintain comprehensive cross-functional and industry perspective, judgement and ability to apply understanding to individual projects and programs.

Requirements

  • PhD in a related subject.
  • 8-10+ years industry-related experience in regulatory PKDM working within the biotechnology or pharmaceutical industry, including previous work with nucleic acid therapeutics.
  • Extensive training in pharmacokinetic analysis and biostatistics, including construction of PK and PK/PD models, simulation, and prediction of first-in-human and human equivalent doses is required.
  • Hands-on experience in all aspects of PKDM study conduct, including: study design, execution interpretation and reporting, in vitro/in vivo PK & PD and ADME, methods, animal models, inter-species scaling, advanced data analysis, modeling and simulation, reporting and compliance.
  • Experience authoring relevant sections of regulatory documents and providing expert representation to global regulatory agencies in support of submissions at all stages of development, ie, IND/CTA, CTD, IMPD, MAA/NDA/BLA/JNDA.
  • Extensive experience in the outsourcing and external oversight of PKDM studies conducted by qualified suppliers.
  • Experience in providing formal scientific/technical due diligence support for Business Development activities is required.
  • Evidence of leadership within the industry, eg such as through peer-reviewed publications or as a participant on expert panels or working groups, is preferred.
  • Must be motivated, creative, energetic, resourceful and adaptable, responding constructively to challenging new ideas, information, situations or criticism.
  • Must be able to balance big picture thinking with fine detail level analysis and have demonstrated ability in problem solving as applied to drug development and program/functional management.
  • Fluency in written and spoken English is required.
  • Domestic and occasional international travel required.

Lexington, MA

We are seeking highly motivated and scientifically rigorous individual to join RaNA and lead our Toxicology efforts.  The successful candidate will report to the Head of Translational Development and will be an integral part of the Research and Development team.

Summary of Role

The Head of Toxicology is responsible for providing strategy, expertise, representation and resources for assessment of drug safety to all program teams and RaNA management across all therapeutic areas and stages of development. S/he will provide leadership and oversight of the Toxicology group, and will work closely with Discovery, Chemistry, Regulatory and Clinical colleagues to assess the safety profiles of optimized leads and early development candidates and determine clinical safe starting dose, dose range, safety margins and anticipated safety parameters to be monitored during clinical development.  In addition, the Toxicology organization will be responsible for design and conduct of all phase-appropriate and registration-enabling studies (e.g., DART, safety pharmacology, carcinogenicity). The successful group leader is expected to maintain a flat, consensus-driven team and to balance big picture, long-term and strategic considerations with tactical, detailed technical aspects in approaching and dealing with project/program or product-related drug safety issues. This individual will be highly analytical, decisive, goal-oriented, and timeline sensitive while maintaining the highest of scientific and ethical standards. The Head of Toxicology develops and implements strategic plans for nonclinical drug safety assessment and actively participates in program teams, providing expert representation to global regulatory agencies as well as collaborating with R&D leadership and assisting in the identification of new business initiatives and in-licensing opportunities. The successful candidate will establish and maintain high quality systems and procedures for outsourcing, managing and reporting regulatory toxicology programs, studies and other activities in support of RaNA portfolio programs and to provide submission-ready documentation for the toxicology components of regulatory submissions.

Key Competencies

  • A broad understanding of the drug development process (both large & small molecule) and the ability to provide expert guidance in designing and implementing nonclinical Toxicology and Safety Pharmacology studies and development programs for biopharmaceuticals including protein therapies, antibodies, oligonucleotides and small-molecule therapeutics.
  • Ability to analyze, interpret and document nonclinical Toxicology data with overall responsibility to ensure that sufficient preclinical safety data and knowledge exist to underwrite safe and effective human administration.
  • Experience within a team environment as both a member and a leader with strong organizational and interpersonal skills, including exceptional oral and written communication skills with a demonstrated ability to write protocols, nonclinical/clinical study reports and scientific peer-reviewed publications.
  • Ability to influence through effective communication, respectful challenge, and persuasion across the Research and development organization is essential.
  • Ability to effectively represent the Company to key external stakeholders, effectively engage and present to staff at all levels, including senior management and technical and business experts clearly and at the appropriate level of detail in representing strategy, results and implications.
  • Demonstrate and maintain comprehensive cross-functional and industry perspective, judgement and ability to apply understanding to individual projects and programs.

Requirements

  • PhD in a related subject, with DABT certification.
  • 10+ years industry-related experience in regulatory Toxicology working within the biotechnology or pharmaceutical industry, including previous work with nucleic acid therapeutics.
  • Hands-on experience in all aspects of Toxicology study conduct including general, genetic, developmental and reproductive toxicology, carcinogenicity, toxicokinetics, and safety pharmacology and environmental risk assessment experience.
  • Demonstrated knowledge of global regulatory requirements and expectations for nonclinical safety assessment packages to support first in human, clinical development, and product registration, including thorough knowledge of GLP, GCP, ICH and other applicable global guidelines.
  • Experience authoring relevant sections of regulatory documents and providing expert representation to global regulatory agencies in support of submissions at all stages of development, ie, IND/CTA, CTD, IMPD, MAA/NDA/BLA/JNDA.
  • Extensive experience in the outsourcing and external oversight of nonclinical Toxicology studies conducted by qualified suppliers.
  • Experience in providing formal scientific/technical due diligence support for Business Development activities is required.
  • Evidence of leadership within the industry, eg such as through peer-reviewed publications or as a participant on expert panels or working groups, is preferred.
  • Must be able to balance big picture thinking with fine detail level analysis and have demonstrated ability in problem solving as applied to drug development and program/functional management.
  • Must be motivated, creative, energetic, resourceful and adaptable, responding constructively to challenging new ideas, information, situations or criticism.
  • Fluency in written and spoken English is required.
  • Domestic and occasional international travel required.

Lexington, MA

We are seeking a highly motivated and scientifically rigorous individual to join our team as an RNA Scientist in our Discovery group. This individual will demonstrate their leadership abilities via a thorough understanding of nucleic acid analytics, characterization, and development. They will work collaboratively within the group and with interdisciplinary teams, as well as building relationships externally with collaborators, CROs, CMOs, etc. There are several innovative projects that are ongoing, so we are looking for an exceptional scientist with either an MS or PhD (and accompanying industry experience) that has the proven ability to manage their time effectively.

Primary Responsibilities

  • Drive novel nucleic acid synthesis and structural characterization and applications towards in vivo protein production
  • Support mRNA batch production needs across multiple disease areas
  • Develop innovative assays for multiple lead programs as well as new discovery targets with focus on enzyme activity, identification, kinetics
  • Lead RNA/enzyme analytical discovery for mRNA platform with focus on characterization, design, execution and development of current and novel assays
  • Provide support for drug substance process development
  • Support and/or manage outside relationships with CROs with focus on assay development, technology transfer and troubleshooting for efficient completion of qualification/validation of all necessary assays to support CMC efforts
  • Build upon group’s instrumentational expertise and provide analytical insight across disciplines for MRT platform in a collaborative effort
  • Prepare technical reports and presentations for clear communication of scientific findings across interdisciplinary teams

Qualifications

M.S and 8+ years of experience in RNA Biology and Analytics (mixed with enzyme/protein experience)

OR

Ph.D. and 1-3+ years of experience in RNA Biology and Analytics (mixed with enzyme/protein experience)

  • Support mRNA batch synthesis and creation/characterization of novel synthetic constructs
  • Direct experience using chromatographic methods (HPLC/UPLC/AKTA), MS, gel electrophoresis, fragment analyzer, etc. Hands-on experience with LC-MS a plus
  • Experience with RNA ligation and reaction optimization is highly desired
  • Hands-on experience with isolation, characterization, quantification and handling of various nucleic acids (DNA, RNA, etc) is mandatory.  Messenger RNA (mRNA) experience would be given extreme preference
  • Analytical expertise (methods, assay development, troubleshooting) around RNA-based therapeutics is mandatory
  • Strong knowledge and execution of enzymatic assay development (ELISA, enzyme activity, western blot, silver stain, etc.) for protein detection characterization and quantification is imperative for success
  • Demonstrated record of successful in vitro/in vivo analysis supporting lead programs including proper RNA handling, tissue handling, protein/RNA isolation, etc. would be advantageous
  • Previous record of working with outside CRO/CMOs for technology transfer, guidance and troubleshooting is highly desired
  • Demonstrated track-record of progressing multiple projects forward under strict timelines
  • Desire to work in a fast-paced environment
  • Excellent organizational and communication skills
  • Strong analytical and problem-solving skills

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

Lexington, MA

We are seeking a highly motivated and scientifically rigorous individual to join our team as a Scientist.   The successful candidate will report to the Associate Director/Group Leader and be an integral part of the MRT Drug Delivery team.  This position offers opportunities to discover, formulate and create leading mRNA formulations for the treatment of a wide array of genetic diseases.

The successful candidate will be responsible for supporting key formulation development for our MRT platform encompassing in vitro/in vivo mRNA formulation screening, nanoparticle design and characterization, new delivery modalities and applications as well as other critical responsibilities. This Scientist will demonstrate leadership via a thorough understanding of nucleic acid delivery and characterization. They will work collaboratively within the MRT group as well as within interdisciplinary teams, while simultaneously building relationships with outside collaborators, CROs, and/or CMOs.

Primary Responsibilities 

  • Conduct laboratory formulation development of mRNA drug targets entailing: production of LNP & polymer-based nanoparticles for invitro/in vivo studies
  • Application of knowledge towards formulation optimization for enhanced cellular uptake, endosomal escape, biodegradation and characterization
  • Focus on alternate routes of administration including local delivery, targeting, etc.
  • Develop stabilized formulations, lyophilization, improved thermal properties, etc.
  • Work closely with select CROs with focus on in vivo studies, drug carrier design/development, assay development
  • Prepare technical reports and presentations for clear communication of scientific findings across interdisciplinary teams
  • Manages time effectively demonstrating ability to perform multiple projects at one time

Qualifications

  • Ph.D. in Chemistry, Chemical engineering or Biochemistry
  • 1-3 years of industrial experience preferred
  • Demonstrated success in nucleic acid delivery and the development of novel drug carriers with hands-on experience in lipid nanoparticle (LNP) formulations, polymer-based nanoparticles & characterization (required)
  • Direct experience with messenger RNA encapsulation/quantification/characterization/handling is preferred
  • Working knowledge of organic chemistry and its applications to drug delivery (preferred)
  • Demonstrated thorough understanding of intracellular pathways, biodistribution parameters, kinetics, etc.
  • Previous experience designing successful drug products for various routes of administration (subcutaneous, intramuscular, pulmonary, GI, CNS, etc.)
  • Familiarity with lyophilization theory and techniques
  • Strong disposition for analytics (QC, methods, assay development)
  • Demonstrated experience in working with outside CROs/CMOs
  • Desire to work in a fast-paced environment
  • Excellent organizational and communication skills
  • Strong analytical and problem-solving skills

 RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

Lexington, MA

We are seeking a highly motivated and organized individual to join our team as a Project Manager.   The successful candidate will report to the Vice President of Manufacturing and be an integral part of the CMC team.  This position offers opportunities to work with multiple external CROs and CMOs in addition to the RaNA Therapeutics team.  The successful candidate will be responsible for management of multiple external CMC-related projects.

Primary Responsibilities

  • Manage CMC projects outsourced to multiple CROs / CMOs. Collaborate with internal and external teams to set priorities, plan activities, monitor progress, make decisions, resolve issues and identify risks and mitigation plans.
  • Track timelines, milestones and deliverables for outsourced projects to provide input into overarching program plan.
  • Manage inventory of multiple raw materials required for drug substance and drug product production. Coordinate with multiple vendors to order required raw materials and monitor outstanding deliveries.
  • Review and approve project/product related documentation including protocols, reports, procedures and specifications.
  • Assist in compilation of CMC information to support IND applications.
  • Assist in the development of new contracts with external CROs / CMOs. Track invoices against purchase orders.  Assist with budget planning and development.

Qualifications

  • Bachelor’s or Master’s degree in life sciences or engineering.
  • 5-8 years (Bachelor’s) / 3-5 years (Master’s) experience in a similar position, 5-10 total years’ experience in the biotechnology / pharmaceutical industry.
  • Demonstrated success in managing multiple projects effectively.
  • Ability to effectively represent the Company to external CROs and CMOs.
  • Knowledge of product development process including typical Chemistry, Manufacturing and Controls (CMC) activities.
  • Experience with analytical method development and qualification, process development, and cGMP manufacturing and release.
  • Desire to work in a fast-paced environment.
  • Excellent organizational and communication skills.
  • PMP certification desirable.

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

Lexington, MA

We are seeking a highly motivated and scientifically rigorous individual to join our team as an Associate Scientist, mRNA Process Development and Biological Characterization. The successful candidate will report to the Associate Director/Group Leader and be an integral part of the MRT team.  This position offers opportunities to discover, create leading mRNA production processes providing crucial drug substance material applicable for the treatment of a wide array of genetic diseases.  The successful candidate will be responsible for supporting mRNA process development for our MRT platform encompassing the development of the largest scale mRNA production in the industry, optimization of current small scale mRNA batch production, full characterization of drug substance material as well as other critical responsibilities.

Primary Responsibilities

  • Support mRNA process development efforts for multiple mRNA drug targets entailing: large-scale batch production, batch record execution/maintenance, optimization of mRNA processes (enzymatic/physical/analytical)
  • Provide accurate and reproducible execution of analytical characterization for full release panel for mRNA drug substance
  • Conduct biological assays such as ELISA, western blot, gel electrophoresis supporting lead programs
  • Prepare technical reports and makes recommendations based on research outcomes

Qualifications

  • M.S. in Biology, Biochemistry, Engineering
  • 6-10 years of industrial experience preferred
  • Demonstrated success in nucleic acid synthesis/handling(RNase-Free)/application with hands-on experience in messenger RNA production/characterization (required)
  • Further experience with process development/scale-up and a working knowledge of batch record documentation is highly desired
  • Familiarity with GMP operations is preferred
  • Strong disposition for analytics (QC, methods, assay development)
  • Ability to conduct routine biological assays including ELISA, western blot, silver stain, gel electrophoresis, etc. would be preferred
  • Handling/analysis of in vitro/in vivo tissue and serum samples is advantageous
  • Desire to work in a fast-paced environment
  • Excellent organizational and communication skills
  • Strong analytical and problem-solving skills

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

Lexington, MA

We are seeking a highly motivated and scientifically rigorous individual to join our team as a Principal Development Scientist. The successful candidate will report to the Vice President, Manufacturing and be an integral part of the MRT team. The position will focus on drug substance and drug product manufacture, drug formulation, regulatory and analytical support, including development, validation, and data review for drug substances and drug products.

Will also provide technical support to the MRT team for the pharmaceutical development of RaNA’s Messenger RNA Therapeutics lead candidates.  The position will help develop scalable and robust formulation processes for drug substance and drug product and serve as the process knowledge link between Process Development and drug substance and drug product manufacturing.

Primary Responsibilities

80%

  • Provide technical leadership for drug product development and tech transfer activities.
  • Author/review development documents and support IND regulatory submissions
  • Represent within cross functional project teams including process development, CMC and tech transfer teams
  • Will provide support in laboratory to Process Development team when needed as it relates to manufacture of DS or DP.          
  • Manages and oversees the development of drug substances and drug formulations and/or transfer of development activities with RaNA contractors.
  • Provides technical input for selecting external RaNA contractors as well as managing the day-to-day contractor activities with MRT Program Managers.
  • Leads drug /device compatibility assessment activities.
  • Works closely with GMP manufacturers of drug products and drug substances.
  • Writes/reviews protocols and performs batch record review for manufacturer of drug substances and drug products.
  • Writes/reviews analytical method protocols and stability protocols.
  • Writes CMC and drug/device compatibility documents to support IND filings.
  • Provides any necessary support to line manager as required

20%

  • Assists in the review and evaluation of CMC documents during a due diligence exercise.
  • Uses DOE and QbD principles in developing robust API and Finished Product manufacturing processes

Key Skills and Competencies

  • The principal development scientist position will work closely with groups within MRT including Process and Analytical Development as well as external contract organizations, and participate /lead tech transfer teams and work with CMO on cGMP manufacture and release of drug product.
  • Extensive experience and demonstrated track record in biopharmaceutical development including but not limited to formulation development, drug product development, drug product process characterization and validation.
  • In-depth understanding of nucleic acid drug development, formulation, delivery systems and drug/device characterization.
  • Must be well-organized and self-motivated, and possess an independent work style.
  • Ability to lead effectively and concurrently on multiple projects in a goal-oriented, timeline-driven, and dynamic work environment while ensuring quality and accuracy.
  • Proactively identify potential issues and develop creative solutions to technical problems to keep projects on schedule.
  • Excellent interpersonal skills with the ability to interact professionally and effectively with peers, management, and leadership both within and outside RaNA.

Qualifications

  • Ph.D. degree in pharmaceutical chemistry, biochemistry, engineering or related disciplines.
  • Minimum of 8 years of experience in pharmaceutical development and manufacturing of nucleic acid-based therapeutics.
  • Experience with PD/mfg, release testing, formulation development, drug/device characterization

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.