Principal Downstream Processing Engineer
jfo_jfm_biopharmaceutical-manufacturing-operations-downstream-processing · P6 — P6 — Principal Professional · Individual contributor
Serves as the top technical authority for downstream biopharmaceutical purification processes across manufacturing operations.
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The identity block — every fact is canon, none is generated.
6 of 8
Track
Individual contributor
Family rungs priced
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Coordinates
2 / 4 spaces
pay@2 · 2026-07
What this role is
Serves as the top technical authority for downstream biopharmaceutical purification processes across manufacturing operations. At the Principal Professional (P6) level, the role owns organization-wide architecture and the hardest problems, strategic, open-ended problems shaping the technical future, and drives organization-wide. Recognized authority; multiplies many teams.
What this level does
- Advance the downstream platform across the organization by improving efficiency and cost effectiveness through research and innovation, assessing emerging technologies and industry best practices against the current purification paradigm.
- Set the process robustness and viral-safety design basis that manufacturing teams rely on — using predictive analysis of clearance, capacity, and failure modes rather than trial-and-error alone — so processes transfer right the first time.
- Collaborate with academia, industry, and vendors to drive development and early adoption of novel purification technologies (e.g., continuous/connected chromatography, single-use trains).
- Supervise, coach, and develop talent within the downstream function, guide career development, and build strong, collaborative teams while shaping the multi-year downstream technology roadmap.
- Knowledge applied
- Field-shaping authority on downstream platforms who uses predictive analysis of clearance, capacity, and failure modes to set the design basis before building.
- Complexity & problem solving
- Solves organization-wide problems and drives innovation, resolving conflicting cross-operation trade-offs on incomplete knowledge to ensure right-first-time transfer.
- Collaboration & interaction
- Influences industry and company direction; partners with academia, industry, and vendors and provides high-level mentorship to the function.
- Typical experience
- 15+ years; principal downstream expert, often with a PhD and industry leadership.
Skills at this level
- Chromatography unit operations
- — Executes and develops capture and polish chromatography steps for protein purification, selecting and sequencing columns to remove impurities while preserving product yield.
- Ultrafiltration / Diafiltration (UF/DF)
- — Operates and optimizes tangential-flow UF/DF steps to concentrate product and exchange buffers into the final bulk drug substance formulation.
- Viral and normal-flow filtration
- — Sets up and runs viral filtration and normal-flow filtration skids to achieve viral clearance and clarification targets within validated process limits.
- Separation science
- — Applies understanding of chromatography resin selectivity, protein binding thermodynamics, packed-column flow dynamics, and membrane–feed-stream interaction to design and sequence purification steps that reach purity without unacceptable product loss.
- Downstream equipment operation
- — Sets up, operates, cleans, and maintains bioprocess chromatography skids, production-scale columns, UF/DF and viral filtration skids, and mixers for GMP purification runs.
- GMP execution and documentation
- — Follows approved batch records and SOPs to run downstream steps 'Right First Time' under cGMP, recording data in real time with good documentation practices.
- Batch record and SOP authoring
- — Drafts and revises Batch Production Records, SOPs, study protocols, and reports to reflect and improve purification process execution, routing changes through change control.
- Bulk drug substance processing
- — Performs the terminal recovery and formulation steps that convert a harvested feed stream into purified, formulated bulk drug substance ready for fill-finish.
- Purification process development
- — Designs, executes, analyzes, and documents development studies — resin screening, load and pool challenges, filtration optimization — to define robust downstream processes.
- Process scale-up and tech transfer
- — Translates bench and pilot purification processes to GMP manufacturing scale, defining parameters and controls so processes perform reliably on production equipment.
- Process troubleshooting and root-cause analysis
- — Diagnoses recovery, purity, and equipment failures in the downstream train by analyzing in-process and release data to identify and eliminate root causes.
- Viral clearance and process robustness design
- — Predicts impurity clearance, membrane and resin capacity, and failure modes to establish the safety and robustness design basis a purification process is built against.
- Novel purification technology evaluation
- — Assesses and drives early adoption of emerging downstream technologies such as continuous/connected chromatography and single-use trains against current platform performance and cost.
- Team leadership and talent development
- — Supervises, coaches, and develops downstream associates and scientists, reviewing their technical work and guiding career growth within the function.
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https://jobframe.global/profile/jfo_jfm_biopharmaceutical-manufacturing-operations-downstream-processing%3A%3AP6
As of · 2026-07-30
Edition · canon-v2@2.1.0-complete
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