(Associate) Director, Downstream Process Development

(Associate) Director, Downstream Process Development (Antibody/ADC)

Company Summary: Our client is an innovative and rapidly growing company at the forefront of the biotechnology industry. They are seeking a highly qualified and experienced professional for the role of Associate Director/Director of Process Development (Downstream) to lead process development of their novel oncology therapeutic candidates in their pipeline. This role will be located in the San Francisco Bay Area. This key position involves leading the development and optimization of downstream processes, with a particular focus on antibody and antibody drug conjugates (ADCs).

The responsibilities for the Director include:

1. Lead and direct the development and optimization of downstream processes for the production of antibody-based therapeutics, including antibody drug conjugates.
2. Collaborate closely with cross-functional teams to design and execute experiments, utilizing cutting-edge techniques and technologies to drive process improvements and efficiency.
3. Apply your extensive expertise in chromatography, filtration, and other purification methods to enhance product recovery, purity, and yield for antibody and ADC manufacturing.
4. Demonstrate proficiency in conjugation strategies specific to antibodies, ensuring successful development and scale-up of ADC processes.
5. Provide technical leadership and guidance to a team of scientists and engineers, fostering a collaborative and innovative work environment.
6. Establish and maintain effective collaborations with external partners, including contract manufacturing organizations (CMOs) and academic institutions, to leverage expertise and resources for downstream process development and purification.
7. Stay abreast of the latest advancements and trends in downstream process development and purification, particularly in the field of antibody and ADC manufacturing, and actively apply this knowledge to enhance process capabilities.
8. Drive the implementation of robust process characterization and control strategies, ensuring product quality and regulatory compliance throughout the development and manufacturing lifecycle.

The Director should have the following qualifications:

• Bachelor's degree with 18+ years of related experience/Master's degree with 15+ years of experience/PhD with 10+ years of experience.
• Proven track record of successful downstream process development and purification for antibody-based therapeutics, including antibody drug conjugates.
• Experience in developing and optimizing conjugation strategies for antibodies.
• Experience in PC, PPQ, and other late-stage development activities and ability to apply DoE approaches.
• Prior experience working with CDMOs.
• Familiarity with regulatory guidelines and requirements for the development and manufacturing of biopharmaceutical products (IND/IMPD).

Benefits:

• Health, vision, and dental benefits
• Pre-IPO stock options

If you see yourself in this Director role and are interested, then please don't wait to apply.