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Key Responsibilities and Required Skills for Bioprocess Technician

💰 $50,000 - $75,000

BiotechnologyBiomanufacturingQualityLaboratory

🎯 Role Definition

The Bioprocess Technician is a hands-on manufacturing and laboratory professional who executes and documents upstream and downstream bioprocess operations in support of biologics production, process development, and scale-up. Working under cGMP and SOP governance, the Technician operates bioreactors and fermentation systems, performs aseptic cell culture, prepares media and buffers, executes downstream purifications (chromatography, TFF, filtration), collects and processes samples for QC testing, troubleshoots routine process and equipment issues, maintains accurate electronic and paper batch records, and collaborates with engineering, quality, and R&D teams to deliver reproducible, compliant process outcomes. This role requires strong aseptic technique, attention to data integrity, and practical experience with manufacturing equipment and documentation.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Laboratory Technician (Cell Culture / Microbiology)
  • Manufacturing Technician I or Production Associate
  • Quality Control Technician or Research Assistant

Advancement To:

  • Senior Bioprocess Technician or Lead Technician
  • Process Development Associate / Specialist
  • Manufacturing Supervisor or Production Manager
  • Validation Engineer or Quality Engineer

Lateral Moves:

  • Quality Control Analyst
  • Downstream Purification Specialist
  • Analytical Development Technician

Core Responsibilities

Primary Functions

  • Operate, monitor, and document bioreactor and fermenter runs (stirred-tank, single-use, and stainless steel systems) including setup, inoculation, parameter control (pH, DO, temperature, agitation), and sterile sampling to ensure consistent upstream bioprocess performance.
  • Prepare, weigh, and sterile-filter media, supplements, buffers, and reagents following written procedures and batch records to meet production and analytical quality standards.
  • Execute aseptic cell culture techniques for microbial and mammalian cell lines, including thawing, expansion, maintenance, passaging, and scale-up transfers while maintaining sterility and cell line integrity.
  • Perform downstream operations such as tangential flow filtration (TFF), depth and sterile filtration, centrifugation, and multiple modes of chromatography (affinity, ion exchange, SEC) with protocol adherence and accurate process parameter control.
  • Complete and maintain accurate electronic batch records (EBR) and paper batch records, including start-up and shut-down logs, QC sample submissions, and deviation documentation to comply with cGMP and FDA requirements.
  • Conduct routine inline and offline process monitoring (pH, conductivity, turbidity, temperature) and collect representative samples for analytical testing (HPLC, ELISA, UV/Vis, SDS-PAGE) while maintaining chain-of-custody and LIMS entries.
  • Perform routine preventative maintenance, calibration verification, cleaning-in-place (CIP) and sterilization-in-place (SIP) cycles for process equipment and support equipment validation activities as required.
  • Investigate, document, and escalate process deviations, non-conformances, and out-of-specification results following CAPA procedures, and support root cause analysis and corrective action implementation.
  • Execute aseptic fill/finish support tasks including vial fill, stopper placement, and visual inspections in controlled environments, following gowning and cleanroom behavior protocols.
  • Maintain inventory of raw materials, single-use consumables, chromatography resins, and spare parts; coordinate material requests and quarantine/unquarantine materials with QA.
  • Support process transfers and scale-up activities by running pilot batches, collecting performance data, and collaborating with process engineers to ensure scalability and reproducibility of protocols.
  • Prepare and sterilize process lines, single-use assemblies, and connectors, ensuring proper flow path assembly, leak checks, and sterile connections for closed-system processing.
  • Train and mentor junior technicians on bioprocess operations, SOPs, safety practices, aseptic technique, and documentation expectations to build team capability and maintain operational consistency.
  • Maintain cleanroom and production area environmental monitoring programs, perform routine surface and air sampling, and document results to support contamination control and regulatory compliance.
  • Execute sample preparation for in-process and release testing, including dilution, filtration, and labeling, ensuring timely submission to QC laboratories and accurate LIMS data entry.
  • Support process optimization and continuous improvement initiatives by collecting process metrics, proposing operational improvements, and participating in cross-functional improvement teams.
  • Coordinate waste handling and biohazard disposal in accordance with institutional biosafety procedures, local regulations, and environmental health and safety (EHS) guidelines.
  • Participate in internal and external audits and inspections by providing process documentation, demonstrating operations, and implementing agreed corrective actions in collaboration with QA.
  • Maintain equipment logs, SOP revision requests, and training records; actively contribute to revision and improvement of SOPs to reflect best practices and lessons learned.
  • Ensure data integrity and accurate record keeping by reviewing entries for completeness, following ALCOA+ principles, and escalating discrepancies promptly to supervisors and QA.
  • Troubleshoot common process equipment issues including pumps, sensors, probes, and control systems; coordinate with vendors or engineering for complex repairs and downtime mitigation.
  • Support scale-out and commercial production campaigns by preparing materials, executing runs with consistent yields and quality attributes, and communicating production status to stakeholders.
  • Implement and adhere to safety, PPE, and chemical handling procedures, conduct hazard assessments for new operations, and participate in safety training and emergency response drills.
  • Collaborate with analytical and R&D teams to support method transfers, characterization studies, and sample stability programs to inform process decisions and product lifecycle management.

Secondary Functions

  • Assist with basic method development tasks under supervision, such as small-scale bioreactor experiments and initial downstream screening to support process development.
  • Create and maintain training aids, SOP checklists, and quick reference guides to improve operator adherence and reduce training time for common procedures.
  • Support procurement by evaluating consumable usage rates and suggesting vendor consolidation or alternative sourcing to reduce costs and lead times.
  • Participate in weekly production meetings and cross-functional huddles to communicate run results, material needs, and improvement opportunities.
  • Provide on-call support for off-shift troubleshooting and equipment failures during critical batches, ensuring timely resolution to protect product integrity.
  • Help maintain calibration schedules and coordinate third-party vendor calibration activities to ensure uninterrupted compliance and operation.
  • Participate in pilot plant layout and workflow reviews to ensure ergonomic, contamination-controlled, and scalable operations.

Required Skills & Competencies

Hard Skills (Technical)

  • Aseptic technique and sterile processing for mammalian and microbial systems.
  • Bioreactor and fermenter operation (single-use and stainless steel), including setup, control, and harvest procedures.
  • Upstream cell culture (suspension and adherent) experience and knowledge of cell line handling, viability assessment, and contamination control.
  • Downstream purification methods: column chromatography (affinity, ion exchange, SEC), tangential flow filtration (TFF), depth and sterile filtration, and centrifugation.
  • Proficiency with laboratory and manufacturing analytical techniques: HPLC, UV/Vis spectroscopy, ELISA, SDS-PAGE, and basic wet chemistry assays.
  • Electronic batch record systems (EBR) and Laboratory Information Management Systems (LIMS) data entry and sample tracking.
  • Practical knowledge of cGMP regulations, SOP execution, batch record completion, and documentation best practices for regulated biologics manufacturing.
  • Instrument troubleshooting, preventive maintenance, and calibration verification for pumps, sensors, probes, and control systems.
  • Experience with cleaning-in-place (CIP) and sterilization-in-place (SIP) procedures and validation support activities.
  • Familiarity with environmental monitoring programs, contamination control strategies, and cleanroom behavior and gowning.
  • Data integrity practices and ALCOA+ awareness for manufacturing and laboratory records.
  • Basic process development support skills: pilot runs, scale-up awareness, and process parameter characterization.

Soft Skills

  • Strong attention to detail and high standards for documentation accuracy and data integrity.
  • Analytical problem-solving and practical troubleshooting mindset for process and equipment issues.
  • Clear verbal and written communication skills to interact with cross-functional teams, QA, and external vendors.
  • Team player with the ability to train and mentor junior staff and work in collaborative manufacturing environments.
  • Time management and prioritization abilities to meet production schedules and QC submission deadlines.
  • Adaptability to changing protocols, shift work, and high-priority production demands.
  • Proactive continuous improvement orientation with a focus on operational efficiency and quality.
  • Strong safety mindset with consistent adherence to EHS and biosafety protocols.

Education & Experience

Educational Background

Minimum Education:

  • Associate degree (A.S./A.A.S.) in Biotechnology, Biological Sciences, Microbiology, Chemical Technology, or related technical field.

Preferred Education:

  • Bachelor’s degree (B.S.) in Biochemistry, Biotechnology, Chemical Engineering, Microbiology, or related life sciences/engineering discipline.

Relevant Fields of Study:

  • Biotechnology
  • Biochemical Engineering
  • Microbiology
  • Biochemistry
  • Chemical Technology

Experience Requirements

Typical Experience Range: 1–5 years of hands-on experience in bioprocessing, cell culture, fermentation, or biologics manufacturing.

Preferred:

  • 2–4 years of documented GMP manufacturing or bioprocess laboratory experience, including bioreactor operation and downstream purification.
  • Demonstrated experience with electronic batch records, LIMS, and regulated documentation practices.
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