Director, Downstream Processing
jfo_jfm_biopharmaceutical-manufacturing-operations-downstream-processing · M5 — M5 — Senior Director · Management
Directs downstream biopharmaceutical manufacturing operations across multiple production lines or sites, setting strategy and ensuring capacity, compliance, and performance goals are met.
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Management
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Coordinates
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pay@2 · 2026-07
What this role is
Directs downstream biopharmaceutical manufacturing operations across multiple production lines or sites, setting strategy and ensuring capacity, compliance, and performance goals are met. At the Senior Director (M5) level, the role owns multiple functions or a large department, org-level trade-offs and investment, and drives multi-function results. Leads directors and managers.
What this level does
- Direct downstream manufacturing operations at a site or across a CDMO client portfolio through department managers, with decisions impacting overall manufacturing division performance
- Define site-wide methods and standards for downstream process execution, characterization at scale, and manufacturability of transferred purification processes
- Influence executives and major clients on downstream capability, capacity commitments and manufacturing development roadmaps for new modalities
- Establish the strategic equipment, facility and workforce plan for downstream (chromatography, TFF, viral filtration) supporting the multi-year manufacturing pipeline
- Lead resolution of complex, org-wide downstream issues — recurrent yield/quality risk, comparability at technology transfer — coordinating Research through Manufacturing
- Knowledge applied
- Directs site or portfolio downstream operations through managers, defining methods for at-scale purification execution and manufacturability.
- Complexity & problem solving
- Resolves complex, org-wide downstream issues and defines the methods and standards used across the function.
- Collaboration & interaction
- Influences executives and major clients on downstream capability, commitments and development roadmaps.
- Typical experience
- 10–12+ years including second-level management and manufacturing strategy work.
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
Source · canon-v2 cell + salary-benchmark (model)
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