VP, Downstream Processing
jfo_jfm_biopharmaceutical-manufacturing-operations-downstream-processing · E1 — E1 — Director (Executive) · Executive
Executive leader accountable for the strategy, performance, and compliance of all downstream bioprocessing operations across the manufacturing network.
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What this role is
Executive leader accountable for the strategy, performance, and compliance of all downstream bioprocessing operations across the manufacturing network. At the Director (Executive) (E1) level, the role owns a significant function with strategic authority, strategic and cross-functional, and drives function-wide enterprise impact. Executive leadership of a function.
What this level does
- Lead the complete downstream processing function through Directors, owning cGMP execution of chromatography, TFF, viral inactivation, and bulk fill operations against Right-First-Time and batch-record compliance targets
- Set the downstream purification process development strategy and platform for the biologics portfolio, directing design, execution, analysis, and documentation across all stages of purification development
- Own downstream process transfer into the manufacturing site, CMOs, and partner sites, accountable for successful scale-up and technical fit of chromatography and filtration unit operations
- Govern the CAPA and continuous-improvement program for downstream operations, ensuring recurring purification and filter-integrity failures are root-caused and closed
- Represent downstream operations to other executives and major customers, and manage capital planning for new chromatography and filtration equipment specification, commissioning, and qualification
- Knowledge applied
- Applies deep functional expertise in downstream unit operations (chromatography, TFF, viral inactivation, bulk fill) and cGMP purification process development to set the functional strategy; requires detailed company knowledge of the product portfolio and manufacturing network.
- Complexity & problem solving
- Solves functional-strategy problems — platform selection, process transfer risk, capacity vs. compliance trade-offs — where errors carry serious functional and business consequences to supply.
- Collaboration & interaction
- Interfaces with other executives and major customers/CMOs; represents downstream operations in cross-functional forums and technology-transfer negotiations.
- Typical experience
- 12–15+ years of downstream/biomanufacturing and management experience, including leading purification process development and GMP operations through Directors.
Skills at this level
- Downstream Purification Platform Strategy
- — Sets the technology roadmap for biologics purification — selecting and sequencing chromatography (affinity, ion exchange, polishing), tangential-flow and normal-flow filtration, and viral inactivation steps — to meet portfolio yield, purity, and cost-of-goods targets.
- cGMP Manufacturing Governance
- — Ensures downstream operations run to cGMP and good documentation practice, governing Batch Production Records, Master Batch Records, and SOPs so that purification work is executed Right-First-Time across sites.
- Process Transfer & CMO Management
- — Directs transfer of downstream purification processes into internal manufacturing sites, CMOs, and partner sites, ensuring chromatography and filtration unit operations scale and perform reliably at the receiving facility.
- Purification Process Development Leadership
- — Directs the design, execution, analysis, and documentation of all stages of purification process development, converting development-stage processes into robust, transferable manufacturing trains.
- CAPA & Continuous Improvement Governance
- — Governs corrective and preventive action programs for downstream operations, ensuring recurring purification, yield, and filter-integrity failures are root-caused and permanently closed with continuous-improvement discipline.
- Manufacturing Capacity & Capital Planning
- — Plans and arbitrates capital investment in new chromatography and filtration equipment and facilities — specification, commissioning, and qualification — against portfolio capacity and network make/buy decisions.
- Viral Clearance & Regulatory Risk Management
- — Owns the regulatory risk associated with viral inactivation/clearance and downstream process changes, ensuring validation and comparability hold across sites and product filings.
- Enterprise Supply Strategy
- — Integrates downstream manufacturing capability, CMO partnerships, and internal capacity into corporate supply and portfolio strategy to protect commercial continuity of the biologics franchise.
- Cross-Functional Manufacturing Integration
- — Aligns downstream purification with upstream cell culture, fill-finish, MSAT, and quality functions so end-to-end biologics manufacturing decisions balance yield, compliance, and throughput.
- Executive & Board Engagement
- — Represents manufacturing/technical operations strategy and enterprise supply risk to the CEO, board, investors, regulators, and industry leaders.
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As of · 2026-07-30
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