Bioprocess Engineer

Bionova Scientific Llc

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 – Downstream is a front-line Subject Matter Expert (SME) responsible for the operational execution of Bionova's downstream bioprocesses, including chromatography, filtration (depth, TFF, virus filtration), and formulation activities. This role ensures consistent delivery of GMP-compliant drug substance through deviation ownership, process troubleshooting, and continuous improvement. The BPS works closely with manufacturing staff and cross-functional teams to mature Bionova's purification processes and drive reliable supply.

Essential Duties and Responsibilities

• Act as SME for downstream operations (column packing, chromatography, UF/DF, filtration, pooling, and formulation).
• Provide technical guidance and floor support for real-time issue resolution.
• Monitor process data and control parameters to ensure consistent product quality.
• Material management and coordination with Supply Chain.

• Investigate, manage, and own downstream-related deviations in the Quality Management System.
• Perform root cause analysis and implement effective CAPAs.
• Manage downstream-related change controls and ensure successful implementation.

• Develop and deliver training on chromatography, filtration, and purification workflows.
• Mentor operators on column packing techniques, skid operation, and GMP compliance.
• Ensure robust documentation of training activities.
• Support MSAT with technology transfer.

• Identify and implement process improvements to increase yield, robustness, and efficiency in downstream operations.
• Apply Lean/Six Sigma tools to optimize workflows and reduce variability.

• Author, revise, and review downstream 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

• 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.

• Hands-on experience with purification unit operations (chromatography, filtration, UF/DF).
• Knowledge of process automation platforms (e.g., Unicorn, DeltaV).
• Familiarity with biochemical principles underlying protein purification.
• 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 downstream issues and coach others effectively.
• Strong problem-solving and facilitation skills.

• Experience in training/mentoring operators in GMP downstream 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.

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.