Senior Supervisor, Downstream Processing
jfo_jfm_biopharmaceutical-manufacturing-operations-downstream-processing · M2 — M2 — Manager II · Management
Senior supervisor overseeing downstream purification operations and the shift-based operators who execute them.
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pay@2 · 2026-07
What this role is
Senior supervisor overseeing downstream purification operations and the shift-based operators who execute them. At the Manager II (M2) level, the role owns an established team or sub-function, cross-project coordination and priorities, and drives group delivery and development. Manages a team; sometimes manages leads.
What this level does
- Manage a team of skilled downstream associates and a lead across production runs, owning tactical delivery of the shift's clarification and purification batches to schedule and quality targets
- Coordinate cross-functionally with Quality, buffer/media prep and materials to sequence equipment set-up, chromatography column packing and buffer availability, resolving scheduling conflicts within known constraints
- Review and approve revisions to SOPs, study protocols and Master Batch Records authored by team members, and ensure CAPAs from downstream deviations are initiated and progressed
- Oversee commissioning and qualification support for new downstream equipment (chromatography systems, TFF/viral filtration skids) introduced into the unit
- Own operator qualification records, media fill/aseptic processing participation and competency progression for the team
- Knowledge applied
- Applies deeper downstream process and documentation knowledge (SOP/MBR authoring, CAPA, equipment commissioning/qualification) to direct a skilled team and junior lead.
- Complexity & problem solving
- Exercises judgment within known factors to sequence runs and resolve equipment/scheduling conflicts; contributes to protocol and procedure revision.
- Collaboration & interaction
- Cross-functional cooperation with Quality, materials and prep teams to keep chromatography and filtration runs on schedule.
- Typical experience
- 2–5 years in team leadership or specialist downstream roles atop strong hands-on process execution experience.
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
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