Senior Manager/Associate Director, Drug Substance MSAT

About the role

The Associate Director, Drug Substance MSAT, leads end-to-end process stewardship (Upstream and Downstream) for an assigned manufacturing suite (DSM1 or DSM2).

Responsibilities

• Assigns and coaches upstream/downstream scientists, engineers, and team members; directs upstream/downstream technical leads for TT execution and readiness activities; reviews performance and concerns, partners with HR as needed for resolution
• Owns product and process stewardship by leading end to end technical strategy execution for assigned products in the suite from new product introduction through commercialization, covering upstream (seed/production bioreactors) and downstream (purification trains)
• Sets direction in defining and maintaining the process control strategy by translating product critical quality attributes into upstream/downstream critical process parameters, acceptable ranges, and control plans
• Ensures process flow diagram, change controls, and associated documents remain current
• Ensures floor presence, safety, and compliance as well as successful manufacturing process comparability and validation runs
• Drives continuous improvement projects to improve manufacturability, reliability, efficiency, quality, cost, and compliance
• Establishes systems and procedures to enable proactive process monitoring, analysis, and reporting of manufacturing process data (within batch and batch-to-batch)
• Promotes professional development, psychological safety, accountability, personal ownership, and proactive problem-solving; runs effective tier huddles; recognizes contributions and shares learnings (Yokoten)
• Oversees critical manufacturing investigations and deviations; reviews trends, capability, and alarms; determines true root cause; initiates, oversees, and verifies corrective and preventive actions (CAPAs); authors and approves change controls
• Authors Chemistry, Manufacturing, and Control (CMC) sections of regulatory filings; supports the CMC review of regulatory submissions, site inspections, and health authority inquiries, as required
• Partners with Client, Process Development, Quality, Manufacturing, and Engineering on large-scale platform development, technology innovation, scale-up, and manufacturability as part of tech transfer (TT), as needed
• Coordinates cross-functional delivery by collaborating with Manufacturing, Quality, Automation, Engineering, Supply Chain, and other support groups to align schedules, resources, and decisions under tiered governance; utilizes clear decision rights (D.A.I model)
• Functions as a senior leader to support supplier technical evaluations, risk assessments, raw material evaluations, and qualifications
• Administers company policies such as time off, shift work, and inclement weather that directly impact employees
• Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports, etc.)
• Participates in the recruitment process and retention strategies to attract and retain talent, as needed

Requirements

• Master’s degree in an Engineering or Scientific field with 9+ years of experience OR Bachelor’s degree in an Engineering or Scientific field with 11+ years of experience
• 8+ years of people management/leadership experience
• 9+ years of CMC experience leading pre-approval and post-approval activities for biologic product, including process development and Good Manufacturing Practices (GMP)

Preferred Requirements

• 12+ years of experience in similar role with large projects from conceptual design phase to operations
• 8+ years of experience leading technical departments
• Technical leadership experience with drug substance manufacturing facilities
• Prior drug substance development and manufacturing experience including process validation, process transfer, commercialization, manufacturing support, and troubleshooting drug substance operations
• Experience communicating and collaborating with a global team