Manager-Manufacturing Sciences & Technology (MSAT)

New York Blood Center Enterprises•Rye, NY

3d•$150,000 - $160,000

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 Lead end-to-end tech transfer of cell therapy processes (immune cells, stem cells such as HSCs, iPSC, MSC) from development to clinical and commercial manufacturing.
Develop and manage risk assessments, process characterization plans, sampling plans, and transfer protocols.
Own master batch records (MBRs), process descriptions, and other GMP documentation required for transfer.
Interface as a Person-in-Plant (PiP) during engineering and GMP runs to ensure transfer fidelity.
Provide technical leadership in upstream and downstream scale-up, ensuring process robustness and reproducibility.
Coordinate with cross-functional teams (PD, AD, ASAT, Quality, Engineering, Operations) to align on transfer deliverables and timing.
Oversee cleanroom readiness and facility fit assessments, including equipment qualification, and environmental monitoring, aseptic process simulation, cleaning validation (i.e., establishing a cleaning protocol for the room, the BSC, etc.).
Lead equipment qualification and validation activities, ensuring GMP compliance.
Support establishment and maintenance of process monitoring systems (e.g., process trending, critical process parameter (CPP) tracking).
Drive troubleshooting of manufacturing issues, deviations, and investigations, working in partnership with Quality to implement CAPAs and root cause analyses.
Author, review, and approve GMP documentation including batch records, tech transfer reports, protocols, change controls, CAPAs, and deviations.
Maintain and update change control systems, process change assessments, and continuous process verification (CPV) plans.
Provide subject-matter input for regulatory filings (e.g., IND, CTA, BLA), CMC sections, and inspection support.
Manage multiple projects concurrently, prioritizing tasks, timelines, and resources with minimal supervision.
Lead cross-functional technical teams, including PD, AD, ASAT, Quality, Operations, and clients/partners, to deliver transfer and manufacturing milestones.
Identify risks early, propose mitigation strategies, and escalate issues proactively.
Facilitate process performance reviews, steering committees, and status reporting to senior leadership.
Provide technical mentorship and guidance to MSAT engineers/scientists, fostering a culture of continuous improvement and scientific rigor.
Build relationships with client/partner technical leads and internal stakeholders to ensure strong collaboration and alignment.
Support the development of MSAT strategy, resource planning, and capacity building.
Understand and oversee microbiology requirements (sterility, endotoxin, environmental monitoring) in manufacturing processes.
Support appropriate analytical methods transfer, validation, and implementation at manufacturing sites.
Maintain compliance with GMP, cGMP, and regulatory expectations, staying current with industry trends and regulatory guidance.
Lead process optimization initiatives, yield improvement, and cost reduction strategies over the product lifecycle.
Implement and manage continuous process verification (CPV) programs, including annual reporting and trending.
Drive post-transfer improvements, addressing process drift, changes, and scale-up lessons learned.
Act as the voice of MSAT, bridging gaps between development, manufacturing, quality, and regulatory teams.
Present technical updates, risk analyses, and mitigation plans to cross-functional teams and senior leadership.
Facilitate training programs for manufacturing and quality personnel on transferred processes and new technologies.
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.