Principal Scientist, Upstream Development
About The Position
The Biologics Process Research & Development organization develops drug substance manufacturing processes for the company’s biologics pipeline, supports clinical-trial material production, develops commercial processes and new manufacturing technologies, and works with the Manufacturing Division to commercialize and launch products. The Principal Scientist will join the Upstream Development Department and work with its scientists to develop and refine technical strategies for next-generation processing of early- and late-stage clinical assets. The role contributes to CMC development by developing cell-culture processes and transferring them to clinical and commercial manufacturing sites, while also creating strategies for process and pipeline-facing innovation. The position calls for scientific leadership, strong organization and communication, cross-functional collaboration, mentoring, project leadership, and the use of data science and digital tools to address complex problems. The successful candidate will lead upstream development for first-in-human and commercial processes, provide technical direction across development and commercialization activities, advance platform strategy, and foster adoption of new technologies through collaborations with academic, industry, and vendor partners. The role also includes keeping current with relevant literature and patents, presenting and publishing externally, pursuing patenting strategies, and supervising and developing junior scientists.
Requirements
- Ph.D. with 8+ years of industry experience, a master’s degree with 10+ years of industry experience, or a bachelor’s degree with 14+ years of industry experience in Chemical Engineering, Bioengineering, Biochemistry, or a related field.
- Proven accomplishments in upstream process and technology development, with a strong scientific publication and presentation record.
- Experience in CHO fed-batch cell culture and a working understanding of downstream processing and analytics.
- Understanding and hands-on experience with cell-culture bioreactors, including microbioreactors, bench-scale and pilot-scale bioreactors, and scale-up and technology-transfer activities.
- Working knowledge of cell-culture media, CHO cell biology and metabolism, DOE statistics, and computational fluid dynamics.
- Ability to direct planning, execution, analysis, and documentation for all stages of cell-culture process development.
- Ability to work in a matrixed team and collaborate with internal and external partners, including vendors.
- Knowledge of the biologics CMC development cycle.
- Demonstrated initiative, creativity, and innovation in problem solving.
- Ability to develop staff, maximize use of talent, guide career development, and build strong collaborative teams.
- Required skills include adaptability, biodesign, cell-culture process development, cell cultures, cell-line development, chemical engineering, clinical supplies management, clinical trials, combination products, computational fluid dynamics, data analysis, finite element analysis, flux analysis, immunochemistry, innovative thinking, leadership and mentoring, mammalian cell culture, manufacturing processes, media development, pharmaceutical process development, professional collaboration, professional networking, quality by design, and regulatory filings.
Nice To Haves
- Experience with state-of-the-art cell-culture processes, including intensified inoculum and perfusion process development.
- Experience with early- and late-stage commercial process development, technology transfer, scale-down model qualification, and process characterization.
- Experience with high-throughput microbioreactor systems and advanced in-situ analytics for process monitoring and control.
- Expertise in media development and media/solution chemistry.
- Background in data-science approaches to cell culture and predictive modeling, such as metabolic flux analysis, omics, and machine learning; experience integrating PAT efforts and computational fluid dynamics.
- Experience leading cross-functional program development teams.
Responsibilities
- Lead biologic upstream process development for first-in-human and commercial processes, developing high-yield, robust, scalable cell-culture processes.
- Provide technical direction for process development, characterization, commercialization, and regulatory filing activities to support successful PPQs and BLAs.
- Advance upstream platform process technical strategy and champion process-improvement initiatives.
- Initiate collaborations to assess new technologies and industry strategies relevant to the company.
- Collaborate with academia, industry partners, and vendors to develop, innovate, and adopt process technologies with broad project or platform impact.
- Keep up to date with the external patent and literature environment; present and publish externally and pursue patenting strategies.
- Supervise, coach, and educate junior scientists.
- Direct the planning, execution, analysis, and documentation of all stages of cell-culture process development.
- Contribute to CMC development of the company’s pipeline, including cell-culture process development and transfer to clinical and commercial manufacturing sites.
- Develop strategies for process and pipeline-facing innovation.
- Develop staff to maximize talent utilization and guide career development while building collaborative teams.
Benefits
- Medical, dental, and vision healthcare benefits for employees and family.
- Other insurance benefits for employees and family.
- Retirement benefits, including 401(k).
- Paid holidays.
- Vacation.
- Compassionate and sick days.
- Eligible for annual bonus and long-term incentive, if applicable.
- Domestic relocation.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
