Position OverviewThe Associate Director, Drug Substance MSAT, leads end-to-end process stewardship (Upstream and Downstream) for an assigned manufacturing suite (DSM1 or DSM2). The role executes MSAT strategy, builds and develops a team of scientists and engineers, and optimizes large scale cell culture operations across seed/production bioreactors and purification trains. With a focus on innovation and reliability, this leader drives technical stewardship through tech transfer execution, process performance qualification (PPQ) execution, commercialization, as well as continuous improvement initiatives. This leader partners closely with the rest of the MSAT leadership team, Manufacturing, QA, Automation, and Engineering to improve systems and working methods. The Associate Director serves as the suite's technical owner in client forums, translating product requirement needs into clear plans, stage gates, and flawless execution to enable compliant, on time Drug Substance delivery.
Job DescriptionWhat You'll Do:- 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
- Performs other duties, as assigned
Minimum 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
