Associate Director of Process Development, AFD

Associate Director of Process Development, AFD

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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 accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings.

Bionova Scientific LLC

Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products. As part of our business expansion plan, we are building a state-of-the-art facility that specializes in the development and manufacturing of Plasmid DNA. This facility will be equipped with cutting-edge technology and staffed by a team of highly skilled professionals dedicated to advancing the field of Plasmid DNA process development and manufacturing.

The Associate Director of Analytical and Formulation Development will be responsible for managing analytical activities in support of drug substance and drug product development. This position requires experience with clinical-stage product development, and method development/validation/transfer.

• Oversee and manage a team engaged in AFD and QC transfer activities. Act as an SME for Analytical Development in the support of drug substance and drug product development, including process chemistry and formulation development.
• Provide technical review of analytical data integrity, method development, and method validation protocols/reports.
• Represent functional CMC role and participate in cross-functional project teams, managing multiple priorities in a fast-paced, dynamic environment and enacting quick problem solving to ensure on-time supply of drug to support GLP toxicology studies and IND-enabling activities across a portfolio of programs.
• Act as primary liaison for analytical testing performed by external contract organizations and review data collected.
• Ensure that testing methodologies meet phase-appropriate cGMP requirements.
• Work with internal subject matter experts to author and review analytical test methods, protocols, and development reports.
• Review method transfer reports, qualification/validation plans, and reports by clients.
• Author analytical CMC modules to support regulatory filings.
• Develop sensitive and robust analytical test methods to support release testing and characterization of drug products.
• Lead and guide the junior analysts for daily analytical activities.

• This position requires working 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.

• Ph.D. or Master’s degree in biochemistry, analytical chemistry, biology or related discipline with 8‑10+ years’ experience, or BS for 15+ years’ experience in an analytical and/or QC laboratory.
• In-depth hands‑on experience and understanding of protein chemistry and industry‑standard analytical tools (CE, HPLC/UPLC, Mass Spec, ELISA, qPCR assays, compendial assays, etc.) and troubleshooting.
• In depth…