Principal Scientist, Upstream Process Development

Merck • Rahway, NJ

2d • $173,200 - $272,600

About The Position

The Biologics Process Research & Development organization develops drug substance manufacturing processes for the company’s biologics pipeline. It works with Discovery, Pre-clinical and Early Development to develop manufacturing processes for varied biotherapeutics and supply material for clinical trials, and performs late-stage process development and characterization in preparation for commercial manufacturing. The organization also partners with the Manufacturing Division to commercialize and launch new products.

The Principal Scientist leads cross-functional teams in developing CMC packages for pipeline assets and collaborates with Bioprocess Development colleagues on technical strategies for next-generation processing in early- and late-stage clinical development. The role contributes to CMC development, leads upstream cell culture process development and technology transfer to clinical and commercial manufacturing sites, and develops strategies for process and pipeline-facing innovation. It calls for scientific leadership, effective organization and communication, collaboration, mentoring, project leadership, and the ability to apply data science and digital tools to complex problems.

Requirements

• Ph.D. with at least 6 years of industry experience, or a Master's degree with at least 8 years of industry experience, in Chemical Engineering, Bioengineering, Biochemistry, or a related field.
• Experience mentoring and educating junior scientists.
• Proven accomplishments in upstream process and technology development, with a strong scientific publication and presentation record.
• Experience in CHO fed-batch cell culture and working understanding of downstream processing and analytics.
• Hands-on experience with cell culture bioreactors, including microbioreactors and bench- and pilot-scale bioreactors, as well as scale-up and technology transfer.
• Working knowledge of cell culture media, CHO cell biology and metabolism, DOE statistics, and computational fluid dynamics.
• Ability to direct the planning, execution, analysis, and documentation of 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.
• Experience with late-stage commercial process development, technology transfer, scale-down model qualification, and process characterization.
• Demonstrated initiative, creativity, and innovation in problem solving.
• Ability to develop staff, maximize utilization of talent, guide career development, and build collaborative teams.

Nice To Haves

• Experience with state-of-the-art cell culture processes, including intensified inoculum and perfusion process development.
• 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 upstream biologic process development for first-in-human and commercial processes, developing high-yield, robust, and 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 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.
• Monitor external patent and literature developments; present and publish externally and pursue patenting strategies.
• Mentor and educate junior scientists.
• Direct planning, execution, analysis, and documentation of all stages of cell culture process development.
• Lead cross-functional teams developing CMC packages and contribute to process transfer to clinical and commercial manufacturing sites.
• Develop strategies for process and pipeline-facing innovation.

Benefits

• Medical, dental, and vision healthcare and other insurance benefits for employees and family.
• Retirement benefits, including a 401(k).
• Paid holidays, vacation, and compassionate and sick days.
• Eligible for an annual bonus and long-term incentive, if applicable.
• Domestic relocation.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree