Director, Cell Culture and Fermentation Sciences
AstraZeneca
- Gaithersburg, MD
- Permanent
- Full-time
- Drives strategy and provides leadership in the development of innovative technologies (including PAT), digitalization, and automation of upstream processes for traditional and emerging biologic modalities
- Drives development and implementation of agile and risk-based approaches to define CMC strategies for process development and characterization to support efficient and accelerated project delivery
- Provides technical leadership and mentorship on strategies and approaches for late-stage process development, process validation, and commercial registration.
- Authors, reviews, and approves technical reports, upstream development sections of regulatory submissions (INDs/BLAs), and responses to questions from health authorities
- Builds positive relationships and partners with other leaders across Biopharmaceutical Development, AZ Bio-Operations, Quality, Regulatory, and external CMOs to ensure that AZ Biologics Portfolio is progressed with a sense of urgency
- Supports the professional development of the members in the CCFS department
- This position requires supervision of 4-6 employees
- Position may require occasional weekend and/or late-night work (campaign support) and potential travel to manufacturing sites (domestic and international)
- Advanced education (Ph.D or equivalent) in biology, chemical engineering, biochemical engineering, or related scientific field. Must have industrially relevant experience, 10+ years of experience in bioprocess development.
- Consistent track record of success in developing, optimizing, and transferring cell culture processes to manufacturing
- Fundamental understanding of upstream unit operations and scale-up/scale-down principles for biopharmaceuticals
- In depth knowledge of CMC aspects of biopharmaceutical development processes.
- Demonstrated ability to lead technical line functions and matrix teams to deliver projects and implement new technologies
- Knowledge of GMP manufacturing principles and documentation
- Excellent teamwork and communication skills, including authoring/reviewing regulatory submissions
- Strong people skills and demonstrated ability to effectively work across a large organization
- Experience with biopharmaceutical modalities in addition to recombinant proteins and/or monoclonal antibodies such as antibody-drug conjugates, viral products, nucleic acids and/or cell therapies
- Extensive knowledge of commercialization activities (process characterization, validation, BLA preparation and inspection support) for biopharmaceutical products