Associate Director/Principal Scientist

Arbeitsbeschreibung

The Associate Director/Principal Scientist, Cell Culture Process Development (Pivotal & Commercial), will be responsible for leading aspects of cell culture development including commercial process development and process characterization for multiple biologics programs during pivotal phases (phases II/III and post-launch). In addition, this role is also expected to lead projects for cell culture process technology development, platform process evolution, and to support cell culture-related regulatory documentation.

Key Responsibilities:

• Optimize and characterize cell culture processes to supply pivotal trials and enable commercialization for monoclonal antibodies, multi-specifics, and novel modalities.

• Lead and/or support entire lifecycle of pivotal activities including process risk assessment, process characterization, preparation of all supporting documentation/reports toward BLA submission, provide support to ensure successful process performance qualifications (PPQ), and author relevant sections of BLA.

• Lead and/or support technology transfer and investigation activities in partnership with the global manufacturing sciences and technologies (MSAT) group.

• Design experiments and perform hands-on cell culture operations in shake flasks, ambr15, ambr250, bench-scale bioreactors, and novel cell culture platforms.

• May provide support to pilot plant operation for up to 500 L single-use bioreactor.

• Perform statistical analyses and appropriate modeling to assess process parameter criticality, identify acceptable ranges, and contribute to integrated control strategy.

• Author and review GMP and non-GMP technical documents (reports, regulatory submissions/responses, batch records, SOPs etc.), present in group/cross-functional meetings.

• Participate and work cross-functionally within and outside of biologics technical development to achieve common goals.

• Explore, develop, and implement novel cell culture technologies to meet business needs.

• Manage direct and indirect reports and mentor junior group members while working in a flexible and agile environment.

• Some travel may be required to support technology transfers and provide oversight at external manufacturing facilities.

• Adhere to department budget and all training, compliance and safety requirements.

• Remain current on trends and new technology advancements across the Biopharmaceutical industry.

• Hire, mentor and develop team members within the organization to help build and grow a world-class biologics cell culture process development organization.

Qualifications/Skills/Experience:

• Ph.D. with 5+ years OR M.S. with 8+ years OR B.S. with 10+ in a relevant scientific discipline (biology, bioengineering, chemical engineering, biochemical engineering).

• Experience leading pivotal stage cell culture process development/characterization and implementation in GMP facilities.

• Experience in building high-performing teams through strategic coaching and feedback.

• Hands-on laboratory operations experience including shake flask, high-throughput bioreactor, bench scale bioreactor, and pilot scale cultures.

• Excellent communication, technical writing, and presentation skills and aptitude for creative problem solving.

• Demonstrated ability to collaborate and influence cross-functionally.

• Experience in cell culture media development, and/or employing modeling techniques for upstream process development and optimization is preferred.

• Experience in statistics, design-of-experiments, and data analysis (e.g. JMP, Spotfire).

• Working knowledge of lab automation, data management, data science, knowledge management and data protection.

• Experience with viral vaccines is a plus.

• Passion for inclusion: knowing the business value of diverse teams, modelling inclusion, and embedding the value of diversity in the way he/she/they work.