Manager-Manufacturing Sciences & Technology (MSAT)
About The Position
The Manager, MSAT – Cell Therapy will lead and execute Manufacturing Sciences & Technology (MSAT) strategies across multiple cell therapy projects, overseeing successful technology transfers from Process Development (PD) to GMP manufacturing. This role is critical for enabling scale-up, ensuring cleanroom readiness, and operational execution in a contract development and manufacturing (CDMO) environment. The ideal candidate has deep expertise in cell therapy (e.g., immune cells, HSCs, iPSC, MSC), a strong track record in tech transfer, and experience with GMP documentation, batch records, and regulatory compliance. They will serve as the MSAT voice, bridging PD and manufacturing teams, driving timelines, resolving technical risks, and maintaining high-quality standards under tight timelines.
Requirements
- Bachelor's degree required.
- Advanced degree (Master's or Ph.D.) in a relevant scientific or engineering field.
- 5 - 7 years of experience in MSAT, tech transfer, process development, or manufacturing within the biopharmaceutical or cell and gene therapy industry.
- Strong knowledge of cell and gene therapy manufacturing processes, including viral vector production, cell culture, and purification.
- Demonstrated experience with immune cell therapies (CAR-T, TCR), stem cells (HSC, iPSC, MSC).
- Proven track record in writing and reviewing GMP documentation (MBRs, protocols, batch records, deviations, change controls, CAPAs).
- Experience with cleanroom operations, qualification, and validation.
- Knowledge of cGMP, ICH, regulatory CMC requirements.
- Cultural competency and the ability to communicate effectively in a culturally sensitive manner with both individuals and groups from diverse backgrounds.
- Strong project and time management skills; ability to handle multiple projects simultaneously.
- Excellent communication and cross-functional leadership ability.
- Willingness to travel to manufacturing and development sites (domestic and international) as needed.
- Any combination of education, training and experience equivalent to the requirements above that has supplied the necessary knowledge, skills, and experience to perform the essential functions of the job.
Nice To Haves
- Experience with analytical method transfer is a plus.
- Experience working within a CDMO setting is strongly preferred and will be considered a significant advantage.
Responsibilities
- Technology Transfer & Process Scale-Up
- Cleanroom Readiness & Manufacturing Operations
- Quality Systems & Regulatory Documentation
- Project & Program Management
- Team Leadership & Mentorship
- Microbiology, Analytics & Compliance
- Continuous Improvement & Lifecycle Management
- Communication & Stakeholder Engagement
- Makes recommendations for improvements on laboratory and manufacturing processes and practices.
- Participates in individual or team projects as required.
- Participates in professional development by attending and presenting at conferences and seminars and is an active participant in national organizations.
- Any related duties as assigned.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
1,001-5,000 employees
