Sr./Principal Engineer or Scientist, Process Development, PVU
Moderna and its subsidiary Caperna are working to develop first-in-class mRNA based immunoncology medicines specifically targeted to the genetic background of an individual patient's tumor. Moderna's Personalized Vaccine Unit, an integrated product development team residing in the Technical Development organization, has been tasked with the challenge of applying Moderna's unique mRNA production processes to the manufacturing of individualized mRNA medicines.
Moderna is seeking a Process Development Scientist/Engineer to join the Personalized Vaccines Unit for a position based at their Cambridge, MA site. In this role, you will have the opportunity to drive the development of commercializable mRNA and LNP production and purification processes, as well as DNA template purification. The incumbent will lead a team within the Personalized Vaccine Unit, and will collaborate closely with Moderna's core platform process development, analytical development and process automation teams to adapt existing technologies or develop new technologies for application in personalized medicine manufacturing. Our goal is to enable clinical studies and one day commercial manufacturing, so you will work closely with the Personalized Vaccine Unit's technical operations and QA teams for technical transfer to the manufacturing facility for GMP production.
The successful candidate must be able to work in a fast paced and highly dynamic environment, will value building and mentoring a team, will have relevant experience in large molecule bioprocessing, and will be able to contribute to both process development and commercialization related activities for the Personalized Cancer Vaccines program.
- Oversee development and definition of robust Phase-Appropriate processes for production and purification of personalized mRNA vaccines to enable IND-supporting activities; contribute to IND authoring activities.
- Design, conduct and analyze experiments to define the process, critical parameters, design space, and confirm robust performance of the manufacturing process; develop scale-down models where needed.
- Collaborate with the analytical development teams in support of process development, as well as to drive new analytical method development where required for process characterization.
- Collaborate closely with the process automation team to develop custom automation solutions to streamline the manufacturing of personalized mRNA therapeutics.
- Prepare process descriptions, technical reports, and communicate findings internally and externally as appropriate.
- Lead or contribute to process risk assessments, process validations, and other commercialization related activities in support of advancing through clinical development to product licensure.
- Support the External Manufacturing team as required to enable efficient technology transfer to the GMP manufacturing facility.
- Supervise junior staff in process development activities.
- Minimum Qualifications: BS in Chemical Engineering, Chemistry, Biochemical Engineering, Biochemistry or closely related field, and 7+ years relevant industry experience.
- Preferred Qualifications: MS with 5+, or PhD with 3+ years of relevant experience in process development of biomacromolecules (RNA, DNA, proteins, mAbs, viruses) as well as:
- Hands on experience with macromolecular purification techniques including column chromatography, UF/DF, and non-traditional separations (e.g., ATPS).
- Experience with process scale-up / scale-down for purification of novel biologics
- Working knowledge of statistical design of experiments (DoE) and analysis
- Knowledge of cGMP, ICH, regulatory guidelines and QbD principles as they apply to risk management and product commercialization
- Knowledge of nucleic acid chemistry and biology is a plus
- Ability to thrive in a diverse and fast paced environment
- Experience supervising technical staff
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.