Principal Scientist, Upstream Development

Our Biologics Process Research & Development organization develops drug substance manufacturing processes for our biologics pipeline. We collaborate with Discovery, Pre-clinical, and Early Development teams to rapidly develop manufacturing processes for biotherapeutics and efficiently produce clinical-trial material. We also handle commercial process development and implement new manufacturing technologies, working with our Manufacturing Division to commercialize and launch new products.

About the role

We are seeking a highly motivated and experienced Principal Scientist to join our Upstream Development Department. The successful candidate will develop and refine technical strategies for next-generation processing of assets in early- and late-stage clinical development. This role requires strong scientific leadership, effective organizational and multitasking skills, and superior written and oral communication abilities. A track record of leveraging data science and digital tools to solve complex problems, cross-functional collaboration, mentoring junior scientists, and a strong external scientific presence are highly valued.

Responsibilities

• Lead biologic upstream process development for first-in-human and commercial processes by developing high-yield, robust, and scalable cell culture processes.
• Provide technical direction for process development, characterization, commercialization, and regulatory filing activities to ensure a smooth path to successful PPQs and BLAs.
• Advance upstream platform process technical strategy and champion creative process improvement initiatives.
• Initiate collaborations to assess new technologies and industry strategies relevant to our Company.
• Collaborate with academia, industry partners, and vendors to drive development, innovation, and adoption of new process technologies with broad impact.
• Stay updated with external patent and literature environments; actively present, publish, and pursue patenting strategies.
• Supervise, coach, and educate junior scientists.

Requirements

• Ph.D. with 8+ years of industry experience, Master’s with 10+ years, or Bachelor’s with 14+ years in Chemical Engineering, Bioengineering, Biochemistry, or a related field.
• Proven record of accomplishments in upstream process and technology development, with a strong scientific publication and presentation track record.
• Experience in CHO fed-batch cell culture and a working understanding of downstream and analytics.
• Hands-on experience with cell culture bioreactors, including microbioreactors, bench-scale, and pilot-scale bioreactors, as well as scale-up and tech 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 of all stages of cell culture process development.
• Ability to work in a matrixed team environment and collaborate with internal and external partners, including vendors.
• Knowledge of the biologics CMC development cycle.
• Demonstrated initiative, creativity, and innovation in problem-solving.
• Proven ability to develop staff, maximize talent utilization, and guide career development; builds strong, collaborative teams.

Preferred Qualifications

• 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 related to cell culture and predictive modeling (e.g., metabolic flux analysis, omics, machine learning); experience integrating PAT efforts and computational fluid dynamics (CFD).
• Experience leading cross-functional, program development teams.

Pay

The salary range for this role is $173,200.00 - $272,600.00. An employee’s position within the salary range will be based on factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

We offer a comprehensive package of benefits, including:

• Medical, dental, vision, and other insurance benefits for employees and their families.
• Retirement benefits, including a 401(k) plan.
• Paid holidays, vacation, compassionate, and sick days.

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Schedule

• Travel Requirements: 10%
• Employee Status: Regular
• Relocation: Domestic
• VISA Sponsorship: Available