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-Jia

“I am empowered to make an impact here.”

- Jia Tay, Scientist

Quote-John

“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

“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-Amy

“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

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.

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.

Senior Scientist, Manufacturing Sciences and Technology

Lexington, MA

We are seeking a highly motivated and scientifically rigorous individual to join our team as a Senior Scientist.  The successful candidate will report to the Vice President, Manufacturing and be an integral part of the MRT production team. 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 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.

Key Skills and Competencies

  • Coordinate technology transfer of mRNA and nanoparticle manufacturing processes.
  • Demonstrated expertise in process development/scale-up of drug product formulation.
  • 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.
  • Ability to provide technical support and resolve scale-up and manufacturing issues, 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

  • Chemistry, Chemical engineering or Biochemistry BS/MS with 12+ years of experience or PhD with 6+ years of experience in pharmaceutical or biotechnology company.
  • Demonstrated success in nucleic acid delivery and the development of novel drug carriers with hands-on technology transfer experience in lipid nanoparticle (LNP) and polymer-based nanoparticle formulations.
  • Experience with analytical tools for release and characterization of drug product processes and drug products.
  • Demonstrated ability to apply fundamental scientific and engineering skills to evaluation of processes and development of practical solutions to technical challenges.
  • Strong familiarity with cGMP, ICH and regulatory guidelines
  • Ability to work with CROs/CMOs
  • Desire to work in a fast-paced environment
  • Excellent organizational and communication skills
  • Operational execution 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.

Scientist, Drug Delivery & Process Development

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.

Primary Responsibilities

  • Lead laboratory formulation development of mRNA drug targets entailing: production of LNP/polymer-based nanoparticles for in vivo studies, formulation optimization and characterization
  • Support scale-up activities for large scale production of RNA/carrier drug product (design, execution, batch record production/analysis)
  • Manage outside relationships with CROs with focus on in vivo studies, drug carrier design/development, assay development
  • Develop alternate formulations tailored for various routes of administration
  • Prepare technical reports, presentations, etc. for clear communication of scientific findings to cross-functional groups

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/characterization/handling is preferred
  • Further experience with process development/scale-up is highly desired
  • Working knowledge of organic chemistry and its applications to drug delivery (required)
  • Previous experience designing successful drug products for various routes of administration (subcutaneous, intramuscular, pulmonary, 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.

 

 

 

 

 

Associate Director, Regulatory Operations

Cambridge, MA

We are seeking a highly motivated and scientifically rigorous individual to join our team as Associate Director, Regulatory Operations. The successful candidate will report to the Chief Scientific Officer and be an integral part of the R&D team. This position offers opportunities to develop and execute the global regulatory strategy for a portfolio of mRNA-based therapies. The successful candidate will be responsible for developing and directing global regulatory strategy; planning, overseeing and delivering all regulatory filings; and managing all interactions and meetings with regulatory agencies.

Primary Responsibilities

  • Develop and direct the global regulatory strategy and objectives for multiple mRNA-based therapeutics. As the regulatory lead, represent regulatory on all key internal decision-making teams and on all external interactions with regulatory agencies.
  • Based on technical and regulatory knowledge, provide proactive guidance to internal teams on the development of strategic plans, specifically to identify and assess regulatory risks associated with different strategies; and help internal teams problem-solve complex regulatory and clinical issues, and generate options for decision-making.
  • Lead the development and submission of regulatory documents, e.g., pre-IND and end-of-Phase 2 briefing books, INDs, NDA/BLAs, CTAs, MAAs, and other relevant regulatory filings (responses to regulatory queries, IND safety reports).
  • Lead and facilitate meetings with regulatory agencies and prepare internal teams for these interactions.
  • Clearly communicate the regulatory strategy and deliverables to project teams, and proactively drive project teams and external vendors to meet the designated timelines for deliverables.

Qualifications

  • BA, BS, MA, MS, PhD, MD in science or healthcare preferred, or equivalent relevant experience.
  • At least 8-10 years of regulatory affairs or equivalent experience. The regulatory experience should be sufficiently broad to ensure appropriate regulatory leadership for all stages of development.
  • Demonstrated success in guiding the development of new investigational products, spanning preclinical through Phase 3 clinical development.
  • Hands-on experience in the preparation of regulatory filings, including preparation of INDs and NDAs/BLAs, and pre-IND and end-of-Phase 2 meeting materials.
  • Experience with FDA and EMA interactions, and interactions with other global regulatory agencies highly preferred. Experience in conducting face-to-face and teleconference meetings with regulatory agencies.
  • Strong competency in understanding global regulatory requirements and emerging changes in the global regulatory landscape.
  • Strong analytical and problem-solving skills; specifically, to analyze and interpret scientific and clinical data, and to problem-solve complex regulatory and clinical issues.
  • Ability to present complex issues in oral and written form.
  • Excellent organizational skills.
  • Desire to work in a fast-paced environment.

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

Clinical Program Lead (Associate Director/Senior Manager)

Lexington, MA

We are seeking a highly motivated and scientifically rigorous individual to join our team as Clinical Program Lead. The successful candidate will report to the Vice President of MRT Clinical Operations and be an integral part of the MRT team. This position offers the opportunity to have a primary role in the clinical development of a portfolio of mRNA-based therapies. The successful candidate will be responsible for the strategic and operational oversight, management, and delivery of all clinical studies in the program.

Primary Responsibilities

  • Responsible for the strategic and operational aspects of the clinical studies in the development program for multiple mRNA-based therapeutics. As the Clinical Program Lead, provides functional input into the clinical development plan that is consistent with the goals of the program.
  • Authors, provides input, and/or oversees program and/or study documents.
  • Manages clinical outsourcing and is the representative on CRO and other vendor oversight teams.
  • Manages financial aspects of studies, including CRO and investigator budgets. Provides critical review of contracts and/or work orders, and oversees ongoing performance of CROs and other vendors.
  • Collaborates with project physician, data manager and statistician, and other relevant functional areas on clinical trial design and CRF generation.
  • Oversees study level document generation (e.g., clinical study reports, ICFs, trial submissions to regulatory agencies, pharmacy and lab manuals).
  • Participates in the selection of investigational sites with project physician.
  • Ensures clinical trial site’s adherence to pertinent regulations. Leads ongoing review of data to ensure GCP.
  • Clearly communicate the clinical development strategy and deliverables to project teams and external vendors, and proactively drive project teams and external vendors to meet the designated timelines for deliverables.

Qualifications

  • Bachelor’s degree or nursing qualification is required. Scientific/healthcare field preferred but not required. Advanced degree preferred.
  • Significant clinical research experience (at least 8 years) with evidence of increasing responsibility in a pharmaceutical company or CRO. Clear and thorough understanding of all aspects of clinical trial conduct. Global clinical trial experience is required.
  • Detailed knowledge of current regulatory requirements and guidelines governing clinical research.
  • Participation in IND and NDA/BLA submissions is preferred.
  • Experience leading cross-functional teams.
  • Excellent communication and organizational skills.
  • Desire to work in a fast-paced environment.

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 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 scientifically rigorous individual to join our team as a Senior Scientist.  The successful candidate will report to the Vice President, Manufacturing and be an integral part of the MRT production team. 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 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.

Key Skills and Competencies

  • Coordinate technology transfer of mRNA and nanoparticle manufacturing processes.
  • Demonstrated expertise in process development/scale-up of drug product formulation.
  • 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.
  • Ability to provide technical support and resolve scale-up and manufacturing issues, 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

  • Chemistry, Chemical engineering or Biochemistry BS/MS with 12+ years of experience or PhD with 6+ years of experience in pharmaceutical or biotechnology company.
  • Demonstrated success in nucleic acid delivery and the development of novel drug carriers with hands-on technology transfer experience in lipid nanoparticle (LNP) and polymer-based nanoparticle formulations.
  • Experience with analytical tools for release and characterization of drug product processes and drug products.
  • Demonstrated ability to apply fundamental scientific and engineering skills to evaluation of processes and development of practical solutions to technical challenges.
  • Strong familiarity with cGMP, ICH and regulatory guidelines
  • Ability to work with CROs/CMOs
  • Desire to work in a fast-paced environment
  • Excellent organizational and communication skills
  • Operational execution 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.

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.

Primary Responsibilities

  • Lead laboratory formulation development of mRNA drug targets entailing: production of LNP/polymer-based nanoparticles for in vivo studies, formulation optimization and characterization
  • Support scale-up activities for large scale production of RNA/carrier drug product (design, execution, batch record production/analysis)
  • Manage outside relationships with CROs with focus on in vivo studies, drug carrier design/development, assay development
  • Develop alternate formulations tailored for various routes of administration
  • Prepare technical reports, presentations, etc. for clear communication of scientific findings to cross-functional groups

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/characterization/handling is preferred
  • Further experience with process development/scale-up is highly desired
  • Working knowledge of organic chemistry and its applications to drug delivery (required)
  • Previous experience designing successful drug products for various routes of administration (subcutaneous, intramuscular, pulmonary, 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.

 

 

 

 

 

Cambridge, MA

We are seeking a highly motivated and scientifically rigorous individual to join our team as Associate Director, Regulatory Operations. The successful candidate will report to the Chief Scientific Officer and be an integral part of the R&D team. This position offers opportunities to develop and execute the global regulatory strategy for a portfolio of mRNA-based therapies. The successful candidate will be responsible for developing and directing global regulatory strategy; planning, overseeing and delivering all regulatory filings; and managing all interactions and meetings with regulatory agencies.

Primary Responsibilities

  • Develop and direct the global regulatory strategy and objectives for multiple mRNA-based therapeutics. As the regulatory lead, represent regulatory on all key internal decision-making teams and on all external interactions with regulatory agencies.
  • Based on technical and regulatory knowledge, provide proactive guidance to internal teams on the development of strategic plans, specifically to identify and assess regulatory risks associated with different strategies; and help internal teams problem-solve complex regulatory and clinical issues, and generate options for decision-making.
  • Lead the development and submission of regulatory documents, e.g., pre-IND and end-of-Phase 2 briefing books, INDs, NDA/BLAs, CTAs, MAAs, and other relevant regulatory filings (responses to regulatory queries, IND safety reports).
  • Lead and facilitate meetings with regulatory agencies and prepare internal teams for these interactions.
  • Clearly communicate the regulatory strategy and deliverables to project teams, and proactively drive project teams and external vendors to meet the designated timelines for deliverables.

Qualifications

  • BA, BS, MA, MS, PhD, MD in science or healthcare preferred, or equivalent relevant experience.
  • At least 8-10 years of regulatory affairs or equivalent experience. The regulatory experience should be sufficiently broad to ensure appropriate regulatory leadership for all stages of development.
  • Demonstrated success in guiding the development of new investigational products, spanning preclinical through Phase 3 clinical development.
  • Hands-on experience in the preparation of regulatory filings, including preparation of INDs and NDAs/BLAs, and pre-IND and end-of-Phase 2 meeting materials.
  • Experience with FDA and EMA interactions, and interactions with other global regulatory agencies highly preferred. Experience in conducting face-to-face and teleconference meetings with regulatory agencies.
  • Strong competency in understanding global regulatory requirements and emerging changes in the global regulatory landscape.
  • Strong analytical and problem-solving skills; specifically, to analyze and interpret scientific and clinical data, and to problem-solve complex regulatory and clinical issues.
  • Ability to present complex issues in oral and written form.
  • Excellent organizational skills.
  • Desire to work in a fast-paced environment.

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 Clinical Program Lead. The successful candidate will report to the Vice President of MRT Clinical Operations and be an integral part of the MRT team. This position offers the opportunity to have a primary role in the clinical development of a portfolio of mRNA-based therapies. The successful candidate will be responsible for the strategic and operational oversight, management, and delivery of all clinical studies in the program.

Primary Responsibilities

  • Responsible for the strategic and operational aspects of the clinical studies in the development program for multiple mRNA-based therapeutics. As the Clinical Program Lead, provides functional input into the clinical development plan that is consistent with the goals of the program.
  • Authors, provides input, and/or oversees program and/or study documents.
  • Manages clinical outsourcing and is the representative on CRO and other vendor oversight teams.
  • Manages financial aspects of studies, including CRO and investigator budgets. Provides critical review of contracts and/or work orders, and oversees ongoing performance of CROs and other vendors.
  • Collaborates with project physician, data manager and statistician, and other relevant functional areas on clinical trial design and CRF generation.
  • Oversees study level document generation (e.g., clinical study reports, ICFs, trial submissions to regulatory agencies, pharmacy and lab manuals).
  • Participates in the selection of investigational sites with project physician.
  • Ensures clinical trial site’s adherence to pertinent regulations. Leads ongoing review of data to ensure GCP.
  • Clearly communicate the clinical development strategy and deliverables to project teams and external vendors, and proactively drive project teams and external vendors to meet the designated timelines for deliverables.

Qualifications

  • Bachelor’s degree or nursing qualification is required. Scientific/healthcare field preferred but not required. Advanced degree preferred.
  • Significant clinical research experience (at least 8 years) with evidence of increasing responsibility in a pharmaceutical company or CRO. Clear and thorough understanding of all aspects of clinical trial conduct. Global clinical trial experience is required.
  • Detailed knowledge of current regulatory requirements and guidelines governing clinical research.
  • Participation in IND and NDA/BLA submissions is preferred.
  • Experience leading cross-functional teams.
  • Excellent communication and organizational skills.
  • Desire to work in a fast-paced environment.

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