M6
jfo_jfm_manufacturing-operations-bioprocess-manufacturing-upstream-d::M6
Senior Director, Bioprocess Manufacturing (Upstream/Downstream)

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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6 of 8

Track

Management

Family rungs priced

51-0000

Coordinates

3 / 4 spaces

pay@2 · 2026-07

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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