Downstream Processing Supervisor
jfo_jfm_biopharmaceutical-manufacturing-operations-downstream-processing · M1 — M1 — Manager (Team Lead) · Management
Supervises a team of downstream processing technicians executing purification and formulation operations for biopharmaceutical products.
No pay estimate for this profile yet.
Ask about this role
grounded in this role's JobFrame record + structureDownload this job's description (markdown) → derived live from this record.
Key statistics
The identity block — every fact is canon, none is generated.
1 of 8
Track
Management
Family rungs priced
—
—
—
Coordinates
2 / 4 spaces
pay@2 · 2026-07
What this role is
Supervises a team of downstream processing technicians executing purification and formulation operations for biopharmaceutical products. At the Manager (Team Lead) (M1) level, the role owns a single team, day-to-day delivery and people issues, and drives team output and health. Direct people management of one team.
What this level does
- Supervise a shift crew of downstream operators executing chromatography, UF/DF and viral filtration runs to approved Batch Production Records, ensuring work is completed 'Right First Time' per GMP and good documentation practices
- Assign daily set-up, operation, cleaning and CIP/SIP tasks across downstream skids and mixers, and confirm buffer and media solutions are prepared and staged for each scheduled production run
- Review batch parameter recording and in-process monitoring for completeness and accuracy before batch progression, escalating out-of-limit results to the department manager
- Enforce cleanroom cleanliness, 5S workplace organization and raw material inventory levels within the unit, coaching operators on aseptic behavior and gowning
- Deliver on-the-job training and initial sign-off of junior associates on defined downstream procedures and equipment
- Knowledge applied
- Applies established downstream GMP procedures — chromatography, UF/DF, viral filtration set-up/operation/cleaning and buffer preparation — to direct daily unit operations within approved practices.
- Complexity & problem solving
- Handles limited-scope, largely defined problems arising during runs; escalates out-of-limit parameters and non-routine deviations rather than defining new methods.
- Collaboration & interaction
- Daily interaction with shift operators and immediate peers; routine handoffs to Quality and buffer/media prep.
- Typical experience
- Functional downstream expert with some leadership exposure; typically 5+ years cGMP downstream experience with a HS diploma or a Bachelor's with team-lead exposure.
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.
Model-authored from 21 retrieved sources, then adversarially reviewed by an independent judge panel and held to a minimum-evidence floor before publication. Distinct from corpus-extracted content, which is labelled as such.
Scan / share this profile
Put this on a job description, posting, poster, book, or catalog — it opens this canonical profile.
https://jobframe.global/profile/jfo_jfm_biopharmaceutical-manufacturing-operations-downstream-processing%3A%3AM1
As of · 2026-07-30
Edition · canon-v2@2.1.0-complete
Source · canon-v2 cell + salary-benchmark (model)
Act on this profile
Guides
A guided career narrative for this exact profile — pilot clusters first.
Assessments
Level-scoped evaluation criteria, BARS frames, and structured-interview dimensions — from this profile's canon + O*NET.
Free
Assemble a validated assessment battery for a role from the library's pieces.
Free
Past-behavior-first structured interview questions, anchored rating scales, and panel-scoring instructions — from this profile's canon + O*NET.
Free
The complete work-products kit for one canonical job profile: level-scoped evaluation criteria with BARS frames, structured-interview dimensions and guide, performance criteria, and goal/scorecard templates — all canon-grounded and basis-labeled.
$29
Work-products kits for every level and focus in one job family — the hiring-manager shape: assess, interview, and set goals across the whole ladder consistently.
$99
Every work-products kit across all canonical profiles, refreshed as source editions land.
$49/mo
Every work-products kit across all canonical profiles, refreshed as source editions land. Annual billing (two months free).
$490/yr
JobFrame Enterprise
One job framework. Every talent decision.
The unified, transparent framework your hiring, pay, performance, promotion, learning, and management decisions all build on — recomputed into your org's own maintained edition.
Recalculate for your org