Bioprocess Manufacturing Technician
jfo_jfm_manufacturing-operations-bioprocess-manufacturing-upstream-d · P3 — P3 — Mid-Level Professional · Individual contributor
Experienced individual contributor who independently operates and troubleshoots upstream and downstream bioprocess manufacturing equipment to produce biologic products.
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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 operates and troubleshoots upstream and downstream bioprocess manufacturing equipment to produce biologic products. At the Mid-Level Professional (P3) level, the role owns features or a sub-system end-to-end, adapts existing approaches, and drives project / team outcomes. Mentors juniors informally.
What this level does
- Perform complex upstream biologics manufacturing activities with minimal supervision, independently executing standard cell culture / fermentation unit operations end to end
- Diagnose and resolve recurring upstream process issues, distinguishing equipment faults from process-parameter drift across the seed train and production bioreactors
- Propose and implement process improvements to upstream operations, planning and sequencing own work against batch schedules
- Contribute to new facility startup and equipment commissioning/qualification, drawing on knowledge of both upstream and downstream unit operations
- Coordinate documentation and training updates across the shift, mentoring junior associates on aseptic technique and batch execution
- Knowledge applied
- Applies in-depth upstream process knowledge across cell culture, fermentation, and harvest to execute complex operations independently and support commissioning/qualification.
- Complexity & problem solving
- Evaluates identifiable factors to diagnose recurring process issues and proposes concrete improvements; plans own work against batch schedules.
- Collaboration & interaction
- Networks with senior manufacturing and technical staff, coordinates activities within the shift, and mentors junior associates.
- Typical experience
- 5+ years upstream manufacturing (3+ with advanced 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
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