Senior Manager, Downstream Processing (Biopharmaceutical Manufacturing)
jfo_jfm_biopharmaceutical-manufacturing-operations-downstream-processing · M4 — M4 — Director · Management
Senior manager overseeing multiple downstream processing teams and operations across biopharmaceutical manufacturing.
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pay@2 · 2026-07
What this role is
Senior manager overseeing multiple downstream processing teams and operations across biopharmaceutical manufacturing. At the Director (M4) level, the role owns a function or department, strategic priorities and cross-functional alignment, and drives function-level results. Leads managers; sets direction for the function.
What this level does
- Direct multiple downstream sections or shifts as a critical manufacturing function, where execution failures could jeopardize clinical supply and regulatory commitments
- Set downstream operational strategy and policy — process robustness standards, equipment lifecycle and qualification approach, and staffing models — aligned to plant and program business objectives
- Engage senior manufacturing, Quality and program leadership on downstream capacity, deviation risk and technology-transfer plans for pipeline advancement
- Own the annual operating budget and capital plan for downstream areas, including chromatography media, single-use consumables and skid investments
- Sponsor cross-functional troubleshooting from process development through manufacturing to resolve complex purification performance and yield limits
- Knowledge applied
- Sets downstream policy and robustness/qualification standards, aligning multi-section operations with plant and program objectives.
- Complexity & problem solving
- Solves strategic problems where downstream execution failures could jeopardize clinical supply; balances capacity, risk and cost across sections.
- Collaboration & interaction
- Engages senior manufacturing, Quality and program leaders on downstream strategy, capacity and technology transfer.
- Typical experience
- 8–10+ years with complex multi-team or multi-section downstream leadership.
Skills at this level
- Downstream purification operations
- — Directs GMP execution of recovery and purification unit operations — clarification (depth filtration, centrifugation), chromatography (AEX, SEC, HIC) and TFF for concentration and diafiltration — to yield, purity and schedule targets.
- Chromatography and filtration equipment operation
- — Oversees set-up, operation, cleaning, CIP/SIP and qualification of downstream bioprocessing equipment including chromatography systems, UF/DF and viral filtration skids and mixers.
- Buffer and media preparation management
- — Ensures timely preparation and staging of buffer and media solutions critical to each production run, coordinating prep sequencing with downstream operations.
- GMP and good documentation practices
- — Enforces Right First Time execution to approved procedures, forms and Batch Production Records under Good Manufacturing Practice, good documentation practices and GLP.
- Batch record and SOP authoring
- — Reviews and directs revision and initiation of Batch Production Records, SOPs, Master Batch Records, study protocols and reports for downstream operations.
- Deviation and CAPA management
- — Directs investigation of downstream deviations, writes and drives CAPAs, and uses root-cause findings to prevent recurrence across production runs.
- Aseptic processing and cleanroom control
- — Oversees cleanroom cleanliness, gowning discipline, aseptic processing and media fill qualifications in the downstream manufacturing environment.
- Equipment commissioning and qualification
- — Specifies, commissions and qualifies new downstream equipment and skids, ensuring readiness for GMP production use.
- Technology transfer to GMP manufacturing
- — Manages translation of bench-scale purification processes to GMP manufacturing, ensuring seamless transfer and troubleshooting support during clinical production runs.
- Manufacturing budget and resource planning
- — Owns operating and capital budgets for downstream areas, planning chromatography media, single-use consumables, equipment and staffing to meet production demand.
- Team leadership and operator qualification
- — Builds downstream teams through training, on-the-job qualification, mentorship and competency progression of associates on defined procedures and equipment.
- Process trend and data analysis
- — Evaluates batch and deviation trends and large process data sets to assess integrity, interpret performance limits and direct operational improvements.
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As of · 2026-07-30
Edition · canon-v2@2.1.0-complete
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