Manager-Manufacturing Sciences & Technology (MSAT)

Responsibilities

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.

 

1. 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. 

2. Cleanroom Readiness & Manufacturing Operations

• 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. 

3. Quality Systems & Regulatory Documentation

• 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. 

4. Project & Program Management

• 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. 

5. Team Leadership & Mentorship

• 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. 

6. Microbiology, Analytics & Compliance

• 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. 

7. Continuous Improvement & Lifecycle Management

• 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. 

8. Communication & Stakeholder Engagement

• Act as the voice of MSAT, bridging gaps betwe