Position Overview:

We are seeking an experienced and motivated Scientist II to join the Cell therapy team within the Process Development department to execute on supporting BLA activities associated with PM359 ex vivo cell therapy program. This role is central to overseeing process validation and clinical manufacturing oversight at our CDMO partner and to provide technical documentation needed for regulatory submissions. This is an exciting opportunity to work at the intersection of cell biology, cell processing, bioengineering, and manufacturing to bring a breakthrough genetic medicine to patients in need and to gain experience with product licensure. 

This is a hands-on, technical role where the successful candidate will be involved in multiple technical and external manufacturing activities, so excellent organizational abilities, communications and collaboration are critical. The ideal candidate thrives when working in a fast-paced environment, working with purpose, and making an impact for patients.

 Primary Responsibilities:

• Apply knowledge in ex vivo cell therapy manufacturing unit operations (i.e., cell isolation, electroporation, culture, formulation, and cryopreservation) to prepare technical reports and documents for BLA.
• Use knowledge of CPPs, PARs/NORs and QbD applied to process validation.
• Collaborate with Analytical Development and Quality to document the process control strategy.

• Serve as Subject Matter Expert (SME) to provide on-site support at the CDMO, oversee process execution, contribute to knowledge transfer and operator training, review batch records, investigate and close process deviations, and analyze manufacturing trends to recommend improvements.

• Represent Cell Therapy MSAT on cross-functional team meetings; provide technical assessments and risk mitigation strategies. 
• Broaden experience and expertise by supporting other platform technologies associated with PM359 and then provide expertise to other pipeline programs. 

Qualifications

• PhD in Bioengineering, Chemical Engineering, Immunology, or related life science field with 3+ years of industry experience; or M.S/BS with 8+/10+ years of directly applicable full-time work experience.
• Deep hands-on experience in cell therapy manufacturing including cell isolation, gene editing, electroporation, cell culture, formulation, and cryopreservation
• Experience with automated cell therapy unit operations required (e.g., Rotea, LOVO, CliniMACS); experience with cell therapy analytical methods preferred

• Proven experience overseeing or working within cGMP manufacturing at a CDMO or internal GMP facility, including experience being the Person-In-Plant during campaigns, batch record creation and review.
• Proficiency with DoE and statistical methods for process characterization; ability to link process parameters to product quality outcomes
• Excellent written and verbal communication skills; ability to clearly present technical data to cross-functional audiences.
• Highly self-motivated, detail-oriented, and able to operate independently with strong ownership mindset.
• Comfortable in a fast-paced, matrixed biotech environment with evolving priorities.
• Familiarity with common statistical analysis tools (e.g., JMP, Minitab), project management tools (e.g., Smartsheet), and productivity tools including generative AI (e.g., Claude, ChatGPT).
• Ability to travel to manufacturing site up to 20% of the time as needed.

Preferred Qualifications

• Experience with late-stage HSC or T cell therapy process development, including PPQ execution and/or BLA CMC authorship; rare-disease program experience is considered a plus
• Prior experience as a Sponsor-side person-in-plant representative or as a cell therapy CDMO technical representative working with Sponsors.
• Familiarity with regulatory submission writing and review.