Upstream Bioprocess Engineer

The Asahi Kasei Group operates with a commitment of creating for tomorrow.  Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings.

Company:

Bionova Scientific LLC

Job Description:

Company Summary:

Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems.

Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team.

Position Summary:

The Manufacturing Bioprocess Engineer – Upstream is a front-line Subject Matter Expert (SME) responsible for the operational execution of Bionova’s 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 partners closely with floor staff and cross-functional teams to deliver consistent, high-quality biologics while advancing Bionova’s 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 upstream process parameters (CPPs, CQAs) to ensure compliance with process control strategies.
• Material management and coordination 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.
• Ensure training records are current and compliant with Bionova's standards.
• Support MSAT with technology transfer.

Continuous Improvement

• Identify and implement process improvements to increase yield, robustness, and efficiency in upstream operations.
• 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:

• This position required to work in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching.  The employee must occasionally lift and or move up to 20 pounds independently.

Qualifications

Education & Experience

• BA/BS in Biological Science, Biotechnology, or Biochemical Engineering with 4 years’ experience in upstream pharmaceutical manufacturing; OR
• MS with 2 years’ experience in GMP upstream operations.

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 scientific 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 Range: The base compensation range for this role is between $80,000 and $90,000. However, the actual compensation may vary depending on your experience and qualifications.

Health Benefits and Program: Bionova offers health benefits at a subsidized rate.

Healthcare, Dental, and Vision insurance

Life Insurance and Disability Program: 100% covered by Bionova.

Retirement Plan (401K) Up to 8% of Employer Match

Paid time off up to two weeks

10 days of Holidays and 5 days of Sick Leave.

As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.