Associate 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 material for clinical trials. We also handle commercial process development and the implementation of new manufacturing technologies, working closely with our Manufacturing Division to commercialize and launch new products.

About the role

We are seeking a highly motivated and energetic Associate Principal Scientist to join our Biologics Process Development Department. The successful candidate will demonstrate excellent scientific leadership in Upstream process development, strong organizational and multi-tasking skills, and superior written and oral communication abilities. This role requires cross-functional collaboration, mentoring of junior staff, and a significant external scientific presence.

In this position, you will work with a team of Scientists and Engineers in Upstream Process Development, contributing to CMC development for our pipeline. You will play an active role in designing, developing, and optimizing cell culture processes and transferring these processes to clinical and commercial manufacturing sites. Additionally, you will help develop and refine next-generation process strategies through technology initiatives for assets in early and late-stage clinical development.

Responsibilities

• Lead and participate in upstream process development for first-in-human and commercial processes, focusing on high-yield, robust, and scalable cell culture processes.
• Oversee process development, characterization, and regulatory filing activities to ensure a smooth path to successful PPQs and BLAs.
• Partner with Discovery, Cell Line, Downstream Process Development, Analytical Sciences, and Manufacturing teams to create integrated clinical and commercial process solutions that meet quality-by-design targets with robust control strategies.
• Advance upstream platform processes through creative process improvement initiatives to enhance operational efficiency and reduce costs.
• Collaborate with academia, industry partners, and vendors to drive innovation and adoption of new process technologies.
• Stay current with external patent and literature environments; actively present, publish, and pursue patenting strategies.
• Plan, execute, analyze, and document all stages of cell culture process development in a highly organized manner.
• Deliver complex objectives under aggressive timelines while maintaining productivity and efficiency in the laboratory.

Requirements

• Ph.D. with 4+ years’ experience, Master’s with 8+ years’ experience, or Bachelor’s with 12+ years’ experience in chemical engineering, bioengineering, biological engineering, or a related field.
• Hands-on experience with mammalian cell culture and fed-batch processes for recombinant protein production.
• Scientific understanding of CHO cell biology, metabolism, cell culture media, and engineering principles for large-scale recombinant protein production.
• Working knowledge of statistical methods (design of experiment, multivariate data analysis) and tools (e.g., SIMCA, JMP).
• Understanding of cell culture bioreactors, including microbioreactors, bench-scale, and pilot-scale bioreactors, and bioreactor scale-up principles.
• Proven track record in upstream process and technology development, with a strong publication and presentation history.
• Ability to direct planning, execution, analysis, and documentation of cell culture process development stages.
• Excellent verbal, written, and interpersonal communication skills.
• Ability to work effectively in cross-functional and matrixed teams, collaborating with internal and external partners, including vendors.
• Demonstrated initiative, creativity, and innovation in problem-solving.

Preferred Qualifications

• Experience with cell culture media development.
• Experience with high-throughput microbioreactor systems and advanced in situ analytics for process monitoring and control.
• Experience with state-of-the-art cell culture processes, including intensified inoculum/fed-batch and perfusion process development.
• Background in data science approaches related to cell culture, such as metabolic flux analysis (MFA), omics, machine learning, computational fluid dynamics, and integration of PAT efforts.
• Experience with late-stage commercial process development, technology transfer, scale-down model qualification, and process characterization.
• Knowledge of the biologics CMC development cycle, scale-up/down, and tech transfer to GMP manufacturing sites.

Pay

The salary range for this role is $142,400.00 - $224,100.00. An employee’s position within the salary range will be based on factors including relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

We offer a comprehensive benefits package, 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%
• Relocation: Domestic
• VISA sponsorship available: Yes