Manager, Downstream Processing
jfo_jfm_biopharmaceutical-manufacturing-operations-downstream-processing · M3 — M3 — Senior Manager · Management
Leads a team of downstream processing professionals responsible for purification and recovery operations in biopharmaceutical manufacturing.
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.
3 of 8
Track
Management
Family rungs priced
—
—
—
Coordinates
2 / 4 spaces
pay@2 · 2026-07
What this role is
Leads a team of downstream processing professionals responsible for purification and recovery operations in biopharmaceutical manufacturing. At the Senior Manager (M3) level, the role owns multiple teams or a sub-function, multi-team execution and resourcing trade-offs, and drives sub-function outcomes. Manages managers and/or several teams.
What this level does
- Manage the downstream processing department across shifts, holding accountability for operational output, area budget and adherence of chromatography/UF-DF/viral filtration operations to the CGMP biologics quality system
- Evaluate recurring deviation and batch trend data across production runs to identify systemic process or equipment issues and direct corrective/preventive actions with process development and engineering
- Lead independent improvement projects (e.g., cycle-time reduction, buffer prep automation, equipment qualification campaigns) and manage the associated technical and staffing resources
- Lead or coordinate through supervisors and leads, setting production priorities, staffing plans and training pipelines for the downstream unit
- Partner with Quality and process development on technology-transfer readiness and troubleshooting during clinical or commercial production runs
- Knowledge applied
- Applies departmental management of downstream operations, using trend evaluation across runs to drive process and equipment improvements in a CGMP biologics environment.
- Complexity & problem solving
- Addresses diverse operational and quality issues, evaluating deviation/batch trends and leading independent improvement and qualification projects.
- Collaboration & interaction
- Leads the downstream functional team; partners with process development, engineering and Quality on transfer and troubleshooting.
- Typical experience
- 5–7+ years managing professionals, downstream operations and area budgets.
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%3AM3
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