Bionova Scientific
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Upstream Bioprocess Engineer
role at
Bionova Scientific
Bionova is a rapidly growing biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our success depends on exceeding client expectations and working with top scientific talent in an agile, energized culture.
Position Summary The Manufacturing Bioprocess Engineer – Upstream is a front-line Subject Matter Expert (SME) responsible for the operational execution of upstream bioprocesses, including cell culture, seed train scale-up, and harvest activities. This role ensures reliable GMP manufacturing by troubleshooting operations, driving compliance, and implementing improvements. The BPS team collaborates with floor staff and cross-functional groups to deliver high-quality biologics while advancing manufacturing capabilities.
Essential Duties and Responsibilities
Operational Support: Serve as SME for upstream unit operations (media prep, inoculation, seed train, bioreactor operation, harvest). Provide technical guidance to operators and support resolution of real-time process or equipment issues. Monitor CPPs and CQAs to ensure compliance with process control strategies. Coordinate material flow with Supply Chain.
Deviation & Change Management: Investigate, manage, and own upstream-related deviations in the Quality Management System. Perform root cause analysis and implement effective CAPAs. Manage upstream-related change controls and ensure successful implementation.
Training & Knowledge Transfer: Develop and deliver upstream-specific GMP and technical training for manufacturing staff. Mentor operators on aseptic technique, bioreactor operations, and harvest practices. Maintain training records compliant with standards. Support MSAT with technology transfer.
Continuous Improvement: Identify and implement process improvements to increase yield, robustness, and efficiency. Apply Lean/Six Sigma tools to optimize workflows and reduce variability.
Compliance & Documentation: Author, revise, and review upstream SOPs, Electronic Batch Records, and work instructions. Ensure readiness for audits by maintaining GMP compliance across upstream operations.
Working Conditions: Role requires working in a lab/office setting with the ability to walk, stand, stoop, kneel, crouch, and lift up to 20 pounds occasionally.
Qualifications Education & Experience
BA/BS in Biological Science, Biotechnology, or Biochemical Engineering with 4 years of upstream pharmaceutical manufacturing experience; OR
MS with 2 years of upstream GMP operations experience.
Required Qualifications
Hands-on experience with mammalian cell culture, seed train expansion, and bioreactor operations.
Knowledge of process automation and single-use technologies.
Familiarity with principles driving biologics production.
Strong deviation ownership, CAPA development, and technical writing skills.
Ability to troubleshoot complex upstream issues and coach others effectively.
Strong problem-solving and facilitation skills; experience in training/mentoring operators in GMP upstream processes.
Project management or Operational Excellence/Six Sigma background.
Compensation & Benefits Compensation Range: The base compensation range for this role is between $80,000 and $90,000. Actual compensation may vary based on experience and qualifications.
Health Benefits: Health, dental, and vision insurance; benefits at a subsidized rate. Life Insurance and Disability Program: 100% covered by Bionova. Retirement Plan (401K) with up to 8% employer match. Paid time off: up to two weeks, plus 10 holidays and 5 days of sick leave.
Equal Opportunity Employer: Asahi Kasei believes a diverse workforce will enable us to support changes in the economy, society, and environment.
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Upstream Bioprocess Engineer
role at
Bionova Scientific
Bionova is a rapidly growing biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our success depends on exceeding client expectations and working with top scientific talent in an agile, energized culture.
Position Summary The Manufacturing Bioprocess Engineer – Upstream is a front-line Subject Matter Expert (SME) responsible for the operational execution of upstream bioprocesses, including cell culture, seed train scale-up, and harvest activities. This role ensures reliable GMP manufacturing by troubleshooting operations, driving compliance, and implementing improvements. The BPS team collaborates with floor staff and cross-functional groups to deliver high-quality biologics while advancing manufacturing capabilities.
Essential Duties and Responsibilities
Operational Support: Serve as SME for upstream unit operations (media prep, inoculation, seed train, bioreactor operation, harvest). Provide technical guidance to operators and support resolution of real-time process or equipment issues. Monitor CPPs and CQAs to ensure compliance with process control strategies. Coordinate material flow with Supply Chain.
Deviation & Change Management: Investigate, manage, and own upstream-related deviations in the Quality Management System. Perform root cause analysis and implement effective CAPAs. Manage upstream-related change controls and ensure successful implementation.
Training & Knowledge Transfer: Develop and deliver upstream-specific GMP and technical training for manufacturing staff. Mentor operators on aseptic technique, bioreactor operations, and harvest practices. Maintain training records compliant with standards. Support MSAT with technology transfer.
Continuous Improvement: Identify and implement process improvements to increase yield, robustness, and efficiency. Apply Lean/Six Sigma tools to optimize workflows and reduce variability.
Compliance & Documentation: Author, revise, and review upstream SOPs, Electronic Batch Records, and work instructions. Ensure readiness for audits by maintaining GMP compliance across upstream operations.
Working Conditions: Role requires working in a lab/office setting with the ability to walk, stand, stoop, kneel, crouch, and lift up to 20 pounds occasionally.
Qualifications Education & Experience
BA/BS in Biological Science, Biotechnology, or Biochemical Engineering with 4 years of upstream pharmaceutical manufacturing experience; OR
MS with 2 years of upstream GMP operations experience.
Required Qualifications
Hands-on experience with mammalian cell culture, seed train expansion, and bioreactor operations.
Knowledge of process automation and single-use technologies.
Familiarity with principles driving biologics production.
Strong deviation ownership, CAPA development, and technical writing skills.
Ability to troubleshoot complex upstream issues and coach others effectively.
Strong problem-solving and facilitation skills; experience in training/mentoring operators in GMP upstream processes.
Project management or Operational Excellence/Six Sigma background.
Compensation & Benefits Compensation Range: The base compensation range for this role is between $80,000 and $90,000. Actual compensation may vary based on experience and qualifications.
Health Benefits: Health, dental, and vision insurance; benefits at a subsidized rate. Life Insurance and Disability Program: 100% covered by Bionova. Retirement Plan (401K) with up to 8% employer match. Paid time off: up to two weeks, plus 10 holidays and 5 days of sick leave.
Equal Opportunity Employer: Asahi Kasei believes a diverse workforce will enable us to support changes in the economy, society, and environment.
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