Associate Principal Scientist, Upstream Process Development
Merck
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Benefits offered by this job
Job summary
Merck is seeking an Associate Principal Scientist to join the Biologics Process Research & Development group in Rahway, NJ. The role focuses on designing, developing, and transferring cell culture processes for plant-based biologics from discovery to clinical and commercial manufacturing.
You will lead cross-functional teams and contribute to CMC development with strong scientific leadership. The ideal candidate has a Ph.D.
Qualifications
- Ph.D. or Master's degree with extensive chemical engineering, bioengineering, biological engineering, or related field; 4+ or 8+ years experience respectively.
- Hands-on mammalian cell culture and fed-batch processes to produce recombinant proteins.
- Experience with CHO cell biology, metabolism, media, and large-scale production systems.
- Knowledge of statistics and tools (design of experiments, multivariate data analysis).
- Experience with bioreactor scale-up from lab to commercial scales.
Responsibilities
- Lead upstream process development for first-in-human and commercial processes with high-yield, robust cell culture.
- Manage process development, characterization, and regulatory filing activities for PPQs and BLAs.
- Collaborate with Discovery, Cell Line, Downstream, Analytics, and Manufacturing to develop integrated clinical and commercial processes.
- Advance upstream platform processes through creative improvements to increase efficiency and reduce costs.
- Collaborate with academia, industry partners, and vendors to drive development of new technologies.
- Publish and present externally and pursue patent strategies.
Skills
Education
Tools
Job description
The Biologics Process Research & Development organization within our Research & Development Division is responsible for developing the drug substance manufacturing processes for our Company's biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical and Early Development to rapidly develop manufacturing processes for diverse biotherapeutics and efficiently manufacture material to supply clinical trials. We are also responsible for late-stage process development and process characterization to prepare for commercial manufacturing. We work with our partners in our Company Manufacturing Division to commercialize and launch new products. We are seeking a highly motivated and energetic individual to join our team as an Associate Principal Scientist. In this role, a successful candidate will work closely with a highly motivated team of Scientists and Engineers in the Upstream Process Development area and contribute to CMC development of our company's pipeline, playing an active role in the design, development, and optimization of cell culture processes and the transfer of processes to clinical and commercial manufacturing sites. They must have effective organizational and multi-tasking skills, demonstrated excellent scientific leadership in Upstream process development, and superior written and oral communications abilities. Evidence of strong cross-functional collaboration, significant external presence with scientific excellence, and interest and abilities for mentoring junior staff are also expected.
- Participates in and/or leads upstream process development of first-in-human and commercial processes by efficiently developing high yield, robust, and scalable cell culture processes.
- Responsible for process development, process characterization, and regulatory filing activities to ensure a smooth and clear path to successful PPQs and BLAs for the company's pipeline.
- Partner with colleagues in Discovery, Cell Line, Downstream Process Development, Analytical Sciences, and Manufacturing to develop integrated clinical and commercial process and manufacturing solutions that achieve quality by design targets with robust control strategies.
- Advancing the upstream platform processes through creative process improvement initiatives to increase operational efficiency and reduce costs.
- Collaborate with academia, industry partners, and vendors to drive development, innovation, and adoption of new process technologies.
- Keep current with the external literature environment; actively present and publish externally and pursue patenting strategies.
- Ph.D. with 4+ years' experience or Master's with 8+ years' experience in chemical engineering, Bioengineering, Biological Engineering, or a related field
- Technical background and hands‑on experience with mammalian cell culture and fed‑batch processes to produce recombinant proteins.
- Scientific understanding and working knowledge of CHO cell biology, metabolism, cell culture media and engineering principles for large scale recombinant protein production systems.
- Working knowledge of statistical methods (design of experiment, multivariate data analysis) and tools (SIMCA, JMP, etc.).
- Understanding of cell culture bioreactors including microbioreactors, bench‑scale and pilot‑scale bioreactors, and bioreactor scale‑up principles from laboratory to large scale.
- Proven track record of accomplishments in upstream process and technology development with a strong scientific publication and presentation track record.
- Ability to direct the planning, execution, analysis, and documentation of all stages of cell culture process development.
- Plan, execute, analyze, and communicate complex and critical data in a highly organized manner.
- Excellent verbal, written communication, and interpersonal skills.
- Ability to work effectively in cross‑functional and matrixed team environment; collaborate with both internal and external partners including vendors.
- Demonstrated ability for taking initiative, creativity, and innovation in problem solving.
- Productivity and efficiency working in the laboratory.
- Ability to deliver complex objective under aggressive timelines.
- 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 and predictive modeling, e.g. metabolic flux (MFA) analysis, omics, machine learning; computational fluid dynamics, and experience integrating PAT efforts.
- Experience with late‑stage commercial process development, technology transfer, scale‑down model qualification, and process characterization.
- Knowledge of biologics CMC development cycle and scale‑up/down in addition to tech transfer to GMP manufacturing site.
Cell Line Development, Detail‑Oriented, Downstream Process Development, Drug Delivery Technology, Drug Development, Expression Vectors, Interpersonal Relationships, Leading Project Teams, Molecular Biology, Pharmaceutical Formulations, Pharmaceutical Process Development, Physical Characterization, Stable Cell Lines, Strategic Planning
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights. EEOC GINA Supplement. We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts.
We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
Regular
Domestic
Yes
10%
Not Applicable
Not Indicated
No
n/a
10/1/2026
R399270
The salary range for this role is $142,400.00 - $224,100.00
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
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