Position Overview:

We are seeking a talented, experienced, motivated and resilient Senior Scientist/Engineer to join the cell therapy process development team. This is an exciting opportunity to make a significant impact on process design, process development GLP manufacturing, tech transfer to CDMO and technical collaboration for making clinical supplies of prime-edited cell therapies to support Prime Medicine’s ex vivo clinical programs. You will lead projects independently and within small technical development teams, and work with fellow scientists and engineers in various R&D and CMC teams. You will also serve as a cell therapy process development SME, both within the company, and externally by working with partners. The ideal candidate will be able to excel as a member of a cross-functional team who works closely with colleagues in Research, Technical Development, External Manufacturing/Supply Chain, Clinical Operations and Quality to advance Prime’s cell based pipeline of genetic medicines.

Primary Responsibilities:

• Independently lead the design, execution and analysis of process development studies using biological and engineering principles to develop and improve process steps to support prime-edited cell therapy programs
• Lead discussions with process and analytical/QC team members to gain insights and understanding, identify critical process parameters, and improve process robustness for manufacturing implementation
• Author & review technical reports, SOPs, draft batch records, and sections for regulatory submissions
• Serve as Subject Matter Expert (SME) during process development and technology transfer to CDMOs, and partner with CDMO for cGMP manufacturing of prime edited cell therapy drug products; lead troubleshooting resolutions and investigations
• Support new technology evaluations with emphasis on product quality, productivity and/or process robustness
• Effectively manages junior staff (as needed) to be outstanding members of process development team and company
• Critically evaluate experiment data and communicate scientific findings as oral presentations and written reports

Basic Qualifications:

• PhD in biotechnology, bioengineering, chemical engineering, or related life science discipline with 3+ years of relevant industry experience; MS candidates considered with 6+ years of industry experience
• Hands-on experience in advanced bioprocessing and/or cell and gene therapy process development; experience with hematopoietic stem cells (HSCs) preferred  
• Experience with automated cell therapy unit operations required (e.g., Rotea, LOVO); experience with cell therapy analytical methods preferred
• Experience executing and documenting IND-enabling studies and familiarity with comparability studies
• Experience in collaborating with CDMOs in an GMP environment
• Knowledge of GMP and ICH regulations for advanced therapies
• Knowledge of statistical software (e.g., JMP)
• Strong technical writing and verbal communication skills
• Must be able to effectively manage time across multiple projects with competing timelines/priorities
• Able to work both independently and collaboratively in a fast-paced, dynamic and entrepreneurial setting