Upstream Bioprocess Manufacturing Associate
jfo_jfm_manufacturing-operations-bioprocess-manufacturing-upstream-d · P1 — P1 — Entry-Level Professional · Individual contributor
Entry-level individual contributor performing hands-on upstream bioprocessing tasks such as cell culture and fermentation under close supervision.
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Individual contributor
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Coordinates
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pay@2 · 2026-07
What this role is
Entry-level individual contributor performing hands-on upstream bioprocessing tasks such as cell culture and fermentation under close supervision. At the Entry-Level Professional (P1) level, the role owns own tasks within a defined component, routine problems with known solutions, and drives own deliverables. None — building the craft.
What this level does
- Weigh and check raw materials, prepare and test media or buffer solutions per SOPs and batch instructions (including pH and conductivity adjustments), and maintain a clean room environment to meet regulatory requirements
- Perform cell culture and fermentation operations — inoculation, expansion, and maintenance of cell lines or microbial cultures — under the direction of senior personnel
- Assemble, clean and sterilize process equipment, and perform clean-in-place (CIP) and sterilize-in-place (SIP) procedures on cell-growth equipment
- Complete electronic work instructions and batch documentation, and adhere to Good Manufacturing Practices, SOPs, and safety protocols including handling of hazardous materials and waste disposal
- Knowledge applied
- Applies basic cell culture/fermentation and aseptic procedures under detailed instruction; follows SOPs, batch records, and cGMP rules for media prep, weighing, and equipment cleaning.
- Complexity & problem solving
- Handles routine tasks with standard answers; escalates any parameter excursion or deviation to senior personnel rather than resolving it.
- Collaboration & interaction
- Works within a stable shift team, taking direction from senior associates and supervisors on the manufacturing floor.
- Typical experience
- 0–1 years; new entrant to biomanufacturing, technical certificate or science degree.
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
Edition · canon-v2@2.1.0-complete
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