Associate Director of Process Development, AFD

Asahi Kasei-posted 12 days ago
$150,000 - $170,000/Yr
Full-time • Mid Level
Fremont, CA
5,001-10,000 employees
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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 who are dedicated to advancing the field of Plasmid DNA process development and manufacturing. 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 challenges. 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. 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 and manage multiple priorities in a fast-paced, dynamic environment and enact 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.
  • 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 laboratories.
  • 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 understanding of process development from early to late stage.
  • Demonstrated expertise with analytical method development, phase appropriate method qualification/validation, release and stability testing, product characterization and specification development and justification.
  • Exhibited track record of success in delivering timely execution of CMC activities ranging from non-GMP and IND-enabling material supplies, through GMP clinical trial supplies.
  • Demonstrated knowledge and application of current industry and compendial standards and regulatory authority guidance and expectations, including ICH, FDA, MHRA, and EMA guidelines and USP-NF, Ph. Eur, BP, and JP compendia.
  • Prior experience in early phase and late phase development (both drug substance and drug product).
  • Excellent organizational skills with the ability to work on multiple projects with varying complexity and timelines.
  • Exhibited strong organizational and critical thinking skills with an attention to detail enabling sound, technically driven decision making.
  • Proven strong interpersonal, organization and problem-solving skills
  • 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.
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