Upstream Bioprocess Manufacturing Technician
jfo_jfm_manufacturing-operations-bioprocess-manufacturing-upstream-d · P2 — P2 — Developing Professional · Individual contributor
An individual contributor who operates upstream bioprocess manufacturing equipment and executes cell culture production steps under established procedures.
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Individual contributor
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Coordinates
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pay@2 · 2026-07
What this role is
An individual contributor who operates upstream bioprocess manufacturing equipment and executes cell culture production steps under established procedures. At the Developing Professional (P2) level, the role owns defined deliverables / small features, applies established patterns, and drives own and immediate-team deliverables. May guide interns.
What this level does
- Operate the full range of upstream production equipment in the assigned area — media formulation equipment, glass washers, dispensary, bioreactors, and harvest equipment — during routine, start-up, and product-changeover activities
- Monitor critical process parameters such as pH, temperature, dissolved oxygen, and nutrient levels to hold optimal growth conditions, and troubleshoot deviations during the cell culture or fermentation process
- Execute seed train and bioreactor unit operations in accordance with batch requirements, and execute validation protocols while ensuring strict cGMP compliance
- Use process automation systems (e.g., DeltaV/Syncade, OSI/PI Historian) and business systems (e.g., SAP) to run and record operations
- Write, review, and revise area SOPs, Batch Records, Logbooks, and On-The-Job Trainings, and review executed Batch Records for accuracy
- Knowledge applied
- Operates the full upstream equipment set and automation/business systems using defined procedures; applies working judgment to seed train and bioreactor unit operations in familiar situations.
- Complexity & problem solving
- Handles moderately complex, conventional problems — troubleshooting pH/DO/temperature deviations during a run using established corrective steps.
- Collaboration & interaction
- Builds productive working relationships across the shift; authors and revises SOPs, batch records, and OJTs used by peers.
- Typical experience
- 2+ years in cGMP upstream operations, or a science degree with limited experience.
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 · 2026-07-30
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