Staff Bioprocess Manufacturing Engineer (Upstream/Downstream)
jfo_jfm_manufacturing-operations-bioprocess-manufacturing-upstream-d · P5 — P5 — Expert Professional · Individual contributor
Expert-level individual contributor who drives technical excellence and process optimization across upstream and downstream bioprocess manufacturing operations.
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Track
Individual contributor
Family rungs priced
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Coordinates
2 / 4 spaces
pay@2 · 2026-07
What this role is
Expert-level individual contributor who drives technical excellence and process optimization across upstream and downstream bioprocess manufacturing operations. At the Expert Professional (P5) level, the role owns multiple systems or a technical domain, establishes the approach, and drives org / multi-team outcomes. Leads cross-team technical initiatives.
What this level does
- Own the upstream control strategy for one or more product lines — cell culture process parameters, critical attributes, and the basis of specifications — and defend design choices against process and quality challenges
- Drive data-driven decision-making and technology introduction, maximizing the value of a digital plant through data analytics and process analytical technology (PAT) applied to bioreactor operations
- Independently lead resolution of strategic upstream manufacturing problems where root cause is ambiguous, using historical process data and designed experiments rather than trial-and-error alone
- Set and champion Lean Manufacturing and continuous-improvement initiatives across the upstream area, quantifying yield, titer, and robustness gains
- Act as the internal and cross-site technical authority for upstream science, representing manufacturing sciences in process-transfer and regulatory discussions
- Knowledge applied
- Deep expertise in upstream cell culture science and control strategy; owns process performance for product lines and drives technology/PAT and digital-plant adoption.
- Complexity & problem solving
- Solves strategic, ambiguous upstream problems using process data and designed experiments rather than iterative trial-and-error, foreseeing consequences before at-scale changes.
- Collaboration & interaction
- Builds influential internal and cross-site networks; acts as technical spokesperson in process-transfer and regulatory contexts.
- Typical experience
- 12+ years with extensive upstream biomanufacturing expertise.
Skills at this level
- Aseptic Technique
- — Performs aseptic manipulation of cell cultures within Grade A cleanroom environments, maintaining sterility of media, inoculum, and bioreactor connections to prevent contamination of upstream batches.
- Cell Culture & Bioreactor Operation
- — Inoculates, expands, and maintains mammalian cell lines or microbial cultures and runs seed-train and production bioreactors, controlling growth conditions to meet batch and titer requirements.
- Media & Buffer Preparation
- — Weighs, formulates, and tests upstream media and buffer solutions per batch instructions, adjusting pH and conductivity and verifying raw materials before use.
- CIP/SIP & Equipment Preparation
- — Assembles, cleans, and sterilizes upstream process equipment using clean-in-place and sterilize-in-place procedures to ready bioreactors and ancillary equipment for cell growth.
- Process Parameter Monitoring & Troubleshooting
- — Monitors pH, temperature, dissolved oxygen, and nutrient levels during culture/fermentation and diagnoses and corrects excursions to hold optimal growth conditions.
- cGMP & Batch Documentation
- — Executes operations in compliance with cGMP, completes and reviews electronic batch records and logbooks, and authors and revises SOPs and on-the-job training materials.
- Process Automation & Manufacturing Systems
- — Operates and records upstream production using automation platforms (DeltaV/Syncade, OSI/PI Historian) and business systems (SAP) to run and track batch execution.
- Process Validation & Commissioning
- — Executes validation protocols and supports commissioning and qualification of upstream equipment and facilities during startup and product changeover.
- Upstream Process Improvement
- — Identifies and implements improvements to cell culture and fermentation operations, applying Lean Manufacturing methods to raise yield, robustness, and efficiency.
- Control Strategy & Critical Attributes
- — Understands molecule-specific upstream control strategy and the basis of specifications and critical quality attributes, and applies it to process introduction and defense.
- Process Data Analytics & PAT
- — Applies data analytics and process analytical technology to bioreactor and culture data to drive data-informed decisions and continuously improve upstream performance.
- Technical Documentation & Reporting
- — Generates scientific reports and technical documentation for process changes, deviations, and improvements supporting upstream manufacturing and technology transfer.
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As of · 2026-07-31
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