SVP, Bioprocess Manufacturing (Upstream/Downstream)
jfo_jfm_manufacturing-operations-bioprocess-manufacturing-upstream-d · E2 — E2 — Senior Director (Executive) · Executive
Executive leader accountable for the entire upstream and downstream bioprocess manufacturing organization across the enterprise.
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What this role is
Executive leader accountable for the entire upstream and downstream bioprocess manufacturing organization across the enterprise. At the Senior Director (Executive) (E2) level, the role owns multiple functions or a major area, multi-function strategy and risk, and drives major-area outcomes. Leads function leaders.
What this level does
- Lead multiple manufacturing functions or divisions through VPs — integrating upstream with downstream, MSAT, and manufacturing support — where decisions on capacity and campaign sequencing may impact company product-supply viability
- Resolve cross-functional, high-consequence issues spanning upstream process robustness, digital-plant data analytics, and specification/critical-attribute strategy across the manufacturing value chain
- Negotiate critical matters with top leadership on multi-product upstream campaign trade-offs, network capacity allocation, and investment in bioreactor and fermentation capacity
- Own the multi-site or multi-suite upstream operations budget and the digital/PAT (process analytical technology) roadmap that deepens process knowledge and drives yield improvement
- Accountable for the upstream contribution to BLA-supporting manufacturing and the qualification state of the manufacturing network across the products in the portfolio
- Knowledge applied
- Applies cross-functional knowledge integrating upstream with downstream, support, and digital/PAT capabilities; reasons about abstract, high-consequence trade-offs in multi-product capacity and specification strategy.
- Complexity & problem solving
- Solves cross-functional problems whose outcomes may impact company product-supply viability — network capacity conflicts, multi-product campaign sequencing, BLA-supporting qualification state.
- Collaboration & interaction
- Negotiates critical matters with top company leadership on capacity investment and campaign priorities.
- Typical experience
- 15+ years with strategic leadership of manufacturing functions or significant units, leading through VPs (E1–E2).
Skills at this level
- Upstream Process Ownership
- — Serves as owner of the upstream cell-culture/fermentation process, ensuring new products are successfully introduced into biologics manufacturing and that molecule-specific control strategy is maintained from startup into routine operations.
- Cell Culture and Fermentation Science
- — Applies deep knowledge of upstream cell culture and microbial fermentation processes — inoculation, seed expansion, and production bioreactor operation — to govern growth conditions such as pH, temperature, dissolved oxygen, and nutrient levels for target yield.
- Tech Transfer and PPQ Strategy
- — Directs late-stage upstream process development, technology transfer, Process Performance Qualification (PPQ) strategy, and BLA authoring to move processes into the manufacturing environment.
- External Process Development Oversight
- — Oversees design and execution of upstream process development conducted at CDMOs or external sites, ensuring the work is equivalent to internal standards.
- Digital Plant and Process Analytics
- — Maximizes the benefits of a digital plant, using data analytics and process analytical technology (PAT) to gain in-depth upstream process knowledge and continuously improve process performance.
- GMP Manufacturing Governance
- — Establishes and enforces current good manufacturing practice across upstream operations — batch record execution, SOP authoring, and safe handling of hazardous materials and waste — to sustain a compliant, audit-ready operation.
- New Facility Startup and Qualification
- — Governs commissioning, qualification, and startup of new upstream capacity and equipment, transitioning bioreactor and fermentation suites from build to routine GMP production.
- Manufacturing Network Strategy
- — Sets multi-site upstream capacity allocation, campaign sequencing, and make-vs-CDMO footprint to secure reliable biologics supply across the product portfolio.
- Process Improvement and Technology Adoption
- — Directs implementation of new technologies and process improvements that raise upstream yield, reliability, and cost performance across the manufacturing operation.
- Regulatory and External Representation
- — Represents upstream manufacturing science and control strategy to regulators, partners, and industry bodies during inspections, filings, and technical due diligence.
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https://jobframe.global/profile/jfo_jfm_manufacturing-operations-bioprocess-manufacturing-upstream-d%3A%3AE2
As of · 2026-07-31
Edition · canon-v2@2.1.0-complete
Source · canon-v2 cell + salary-benchmark (model)
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