Senior Director, Bioprocess Manufacturing (Upstream/Downstream)
jfo_jfm_manufacturing-operations-bioprocess-manufacturing-upstream-d · M6 — M6 — Vice President · Management
Senior executive leader overseeing all upstream and downstream bioprocess manufacturing operations across a site or network.
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What this role is
Senior executive leader overseeing all upstream and downstream bioprocess manufacturing operations across a site or network. At the Vice President (M6) level, the role owns a major function or division, enterprise priorities and external factors, and drives division-wide / organization-wide. Leads the leadership of a division.
What this level does
- Define the long-term upstream biomanufacturing strategy across functions/sites, shaping capacity, technology and network decisions
- Lead through senior managers to resolve abstract, cross-functional problems spanning upstream operations, MSAT, quality and supply chain
- Set the technology agenda for upstream — next-generation cell culture/fermentation platforms, automation, digital and PAT — and sponsor major process-introduction programs
- Negotiate with executives on critical upstream investment, capacity and compliance matters and shape GMP operations policy for the function
- Own executive accountability for upstream compliance posture, talent architecture and multi-year investment across the division
- Knowledge applied
- Defines long-term upstream strategy across functions/sites, setting the technology and platform agenda for cell culture/fermentation.
- Complexity & problem solving
- Resolves abstract, cross-functional problems spanning upstream operations, MSAT, quality and supply chain with long-term effect on the function.
- Collaboration & interaction
- Negotiates with executives on critical upstream investment and compliance matters and shapes GMP operations policy.
- Typical experience
- 12–15+ years of deep leadership across departments or divisions.
Skills at this level
- Cell Culture and Fermentation Operations
- — Executes and oversees inoculation, expansion, and maintenance of mammalian cell lines or microbial cultures in bioreactors, controlling growth conditions to produce biologic product upstream.
- Bioreactor Operation
- — Operates and monitors upstream bioreactors and fermenters, maintaining critical parameters (pH, temperature, dissolved oxygen, nutrient levels) to keep cultures within optimal growth ranges through the run.
- Aseptic Technique
- — Performs and enforces sterile operations using biosafety cabinets and validated practices during cell banking, harvest and culture handling to prevent contamination of live-cell systems.
- CIP and Sterilization
- — Prepares upstream equipment through clean-in-place, sterilization and autoclave/washer cycles, readying bioreactors, tanks and filtration systems for GMP use.
- Media and Buffer Preparation
- — Prepares and tests media and buffer solutions per SOP, including pH and conductivity adjustments, to supply defined inputs for cell culture and fermentation.
- GMP Documentation
- — Authors, executes and reviews batch records, logbooks and OJT documents and maintains accurate real-time records so upstream operations remain compliant and inspection-ready.
- cGMP Compliance
- — Applies current Good Manufacturing Practices and SOPs to keep clean-room upstream areas compliant with regulatory requirements and ready for inspection.
- Upstream Process Troubleshooting
- — Diagnoses and resolves cell culture/fermentation and equipment problems arising during runs, restoring operations and preventing recurrence across bioreactor trains.
- Raw Material and Consumable Management
- — Manages readiness of media, buffers and single-use assemblies required for manufacturing so upstream campaigns are not starved of inputs.
- Batch Record Review
- — Reviews executed batch records for completeness and compliance, dispositioning them before QA review to release upstream production steps.
- Continuous Improvement
- — Identifies and implements process-improvement actions in the upstream area, raising yield, reliability and compliance of cell culture/fermentation operations.
- Commissioning and Qualification
- — Leads the upstream contribution to commissioning, qualification and facility startup for new or expanded cell culture and fermentation capacity.
- Process Transfer and Introduction
- — Drives tech-transfer readiness and introduction of new upstream processes onto the manufacturing floor, including PPQ and BLA-support milestones.
- Manufacturing Budget Management
- — Sets and stewards upstream operating and capital budgets, headcount plans and staffing aligned to production and network capacity strategy.
- PAT and Digital Optimization
- — Applies process analytical technology and digital tools to optimize upstream cell culture/fermentation control strategy and drive process-improvement roadmaps across suites.
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As of · 2026-07-31
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