Principal Scientist, Upstream Process Development

Merck; Rahway (NJ); On-site; USD 150,000 - 190,000; Full time

Job summary

Merck in Rahway, NJ is seeking an experienced Biologics Process Development Scientist to lead upstream development for first-in-human and commercial processes. You will provide technical direction for development, characterization, and regulatory filings, while advancing platform strategies and collaborating with external partners.

The role emphasizes mentorship of scientists, publications, and ongoing process improvement in CHO cell culture and scale-up activities at bench- and pilot-scale

Qualifications

• Ph.D. with 6+ years of industry experience or Master with 8+ years industry experience in Chemical Engineering, Bioengineering, Biochemistry or a related field.
• Mentoring and educating junior scientists.
• Proven record of upstream process and technology development with publications and presentations.
• Experience in CHO fed-batch cell culture and understanding of downstream & analytics.
• Hands-on experience with cell culture bioreactors including microbioreactors, bench-scale and pilot-scale bioreactors, scale-up/tech transfer.

Responsibilities

• Lead biologic upstream process development for first-in-human and commercial processes.
• Provide technical direction for process development, characterization, commercialization, and regulatory filing activities.
• Advance upstream platform process technical strategy and drive process improvement initiatives.
• Initiate collaborations to assess new technologies and industry strategies.
• Collaborate with academia, industry partners, and vendors to drive development and adoption of new process technologies.
• Stay current with external patent and literature; present and publish externally and pursue patenting strategies.
• Mentor and educate junior scientists.

Skills

Biologics

Bioreactors

Biotherapeutics

Cell Culture Process Development

Process Development

Regulatory Filings

Technology Transfer

Education

Ph.D. in related field

M.S. in related field

Job description

Job Description

The Biologics Process Research & Development organization within our Company's Research Labs 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 varied 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.

Job Responsibilities

The successful candidate will contribute to CMC development of our Company's pipeline, playing an active role in development of cell culture processes and transfer to clinical and commercial manufacturing sites. They will also develop strategies for process and pipeline-facing innovation. Responsibilities include:

• Leading biologic upstream process development for first-in-human and commercial processes by efficiently developing high yield, robust and scalable cell culture processes.
• Providing technical direction for process development, characterization, commercialization, and regulatory filing activities to ensure a smooth and clear path to successful PPQs an BLAs for our company pipeline.
• Advancing upstream platform process technical strategy and championing creative process improvement initiatives
• Initiating new collaborations to assess new technologies and industry strategies with relevance to our Company.
• Collaborating with academia, industry partners, and vendors to drive development, innovation and adoption of new process technologies with broad impact to projects or platform.
• Keeping current with the external patent and literature environment; actively presents and publishes externally and pursues patenting strategies.
• Mentoring and educating junior scientists

Minimum Education Required

Ph.D. with 6+ years of industry experience or Master with 8+ years industry experience in Chemical Engineering, Bioengineering, Biochemistry or a related field.

Required Experience And Skills

• Mentoring and educating junior scientists
• 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 & analytics.
• Understanding and hands-on experience on cell culture bioreactors including microbioreactors, bench-scale and pilot-scale bioreactors, and scaleup/tech transfer activities.
• 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 environment and collaborate with both internal and external partners including vendors.
• Knowledge of biologics CMC development cycle.
• Experience with late-stage commercial process development, technology transfer, scale-down model qualification and process characterization.
• Demonstrated ability for taking initiative, creativity, and innovation in problem solving.
• Demonstrated ability to develop staff to maximize utilization of talent and actively guides career development; builds strong and collaborative teams.

Preferred Experience And Skills

• 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, media/solution chemistry.
• Background in data science approaches related to cell culture and predictive modeling e.g., metabolic flux analysis (MFA), omics, machine learning; experience integrating PAT efforts) and computational fluid dynamics (CFD).
• Experience leading cross functional, program development teams.

Required Skills

Biologics, Bioreactors, Biotherapeutics, Cell Culture Process Development, Cell Line Development, Combination Products, Computational Fluid Dynamics (CFD), Finite Element Analysis (FEA), Pharmaceutical Process Development, Process Characterization, Process Development (PD), Product Development Lifecycle, Regulatory Filings, Technology Transfer

US And Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

Requirements

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

Additional location(s)

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information

San Francisco Residents Only

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only

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

Employee Status

Regular

Relocation

Domestic

VISA Sponsorship

Yes

Travel Requirements

10%

Flexible Work Arrangements

Not Applicable

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

n/a

Job Posting End Date

11/28/2026

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID

R425484