Senior Bioprocess Manufacturing Specialist (Upstream/Downstream)
jfo_jfm_manufacturing-operations-bioprocess-manufacturing-upstream-d · P4 — P4 — Senior Professional · Individual contributor
Experienced individual contributor who independently executes and troubleshoots 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
Experienced individual contributor who independently executes and troubleshoots upstream and downstream bioprocess manufacturing operations. At the Senior Professional (P4) level, the role owns a system or set of related features, devises new approaches, and drives multi-team / function outcomes. Technical lead for focused efforts; mentors several.
What this level does
- Lead technical support for introducing new or transferred manufacturing processes into the upstream environment, from equipment startup through validation into routine operations
- Analyze upstream process performance across multiple batches, evaluating interacting variables (media, cell line behavior, bioreactor conditions) to identify and resolve root causes of variability
- Select methods and design improvement initiatives for upstream unit operations, and may lead cross-shift or project teams executing them
- Author scientific reports and technical documentation supporting process changes, deviations, and CAPA, and interface with QA, MSAT, and validation groups
- Serve as upstream subject-matter reference on molecule-specific control strategy during scale-up and changeover events
- Knowledge applied
- Applies advanced understanding of upstream process design and molecule-specific control strategy to introduce and stabilize new processes; selects analytical methods and improvement approaches.
- Complexity & problem solving
- Performs in-depth analysis of complex, interacting upstream variables across multiple batches to isolate root causes of variability.
- Collaboration & interaction
- Coordinates across manufacturing, MSAT, QA, and validation; may lead project or cross-shift teams and influence technical decisions.
- Typical experience
- 8+ years, often with graduate education in a life-science or engineering discipline.
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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