astrazenecaGaithersburg, MD
Senior Director, Site Manufacturing Science and Technology, Cell Therapy Technical Operations
Senior Director, Site Manufacturing Science and Technology, Cell Therapy Technical Operations
Senior Director, Site Manufacturing Science and Technology, Cell Therapy Technical Operations
astrazenecaGaithersburg, MD
today
Pharmaceutical Preparation ManufacturingResearch and Development in BiotechnologyBiological Product Manufacturing
Apply for this role (opens in a new tab)Overview:
In this role you lead Site MSAT for cell therapy across a global network, guiding tech transfer, process validation, and commercial manufacturing. You partner with Manufacturing Operations, Quality, Supply Chain and QC to ensure robust, compliant supply from clinical through commercial stages. You will build and mentor site MSAT teams, drive harmonized process strategies, and enable sustained process understanding and regulatory readiness. This position offers a strategic impact on site readiness, product quality, and supply continuity in a fast-paced cell therapy landscape. Compensation / Benefits short-term incentive bonuses equity-based awards retirement programs paid time off health, dental, and vision coverage
Responsibilities:
Define and execute the Site MSAT strategy aligned with Cell Therapy Technical Operations across clinical and commercial stages Build, mentor, and lead Site MSAT teams with deep cell therapy GMP operations and process science expertise Serve as core member of the site Manufacturing Operations team for long-range supply planning and operational excellence Lead late-stage and commercial process execution strategies to harmonize quality and regulatory compliance Represent Site MSAT in technology transfer, process validation, and commercial supply teams Lead Clinical manufacture and PPQ readiness at manufacturing sites (materials, facility, equipment, documentation, operations) Implement Proactive Process Analysis (PPA) and Continued Process Verification (CPV) across sites for ongoing control and understanding Identify and implement process improvements to robustness, cost, throughput, and supply continuity Lead regulatory submissions for site CMC sections and support health authority inspections and audits Maintain compliance with cGMP, ICH guidelines, and global regulatory expectations Develop and defend scientific justifications for SOPs, MBRs, and site-specific changes to approved products Oversee site-specific Change Controls with the global MSAT team Collaborate with Governance through Change Controls and Technical Governance Committees
Key requirements:
12+ years in cell therapy/biologics/vaccines in technical development, manufacturing operations, CMC leadership or CMO management Deep expertise in cell therapy manufacturing processes and technologies; experience in biologics/vector/vaccine contexts Extensive GMP manufacturing operations background and site readiness for clinical and commercial supply Proven ability to build and lead high-performing cross-functional teams leadership cross-functional collaboration strategic thinking cell therapy manufacturing processes and technologies tech transfer process validation
Also on the board Same function, level within a rung
Level
Manager
Location
Gaithersburg, MD
Occupation
Natural Sciences Managers
Industry
Pharmaceutical Preparation Manufacturing
Posted
today