Associate Principal Scientist, Upstream Development

Merck & Co.; Rahway (NJ); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Health benefits

Job summary

Merck & Co. is seeking a highly motivated Associate Principal Scientist to lead upstream process development for biologics. You will drive cell culture process design, optimization, and transfer to clinical and commercial sites, collaborating across discovery, analytics, and manufacturing teams.

Ideal candidates have strong publishing records, cross-functional experience, and a track record of cross-team leadership in bioprocess development, with a focus on scale-up and process robustness.

Qualifications

• Ph.D. with 4+ years in chemical or biological engineering or a related field, or Master's with substantial experience.
• Strong background in upstream mammalian cell culture and bioprocess development.
• Experience with scale-up and technology transfer to manufacturing.

Responsibilities

• Lead/upstream process development for first-in-human and commercial cell culture processes.
• Conduct process characterization and regulatory filing activities for PPQ/BLAs.
• Collaborate with Discovery, Cell Line, Downstream, Analytics, and Manufacturing teams.
• Advance platform processes through improvement initiatives to reduce costs.
• Publish and present externally; pursue patenting strategies as appropriate.

Skills

Mammalian cell culture

Fed-batch processes

CHO biology

Process development

Scale-up principles

Data analysis (DOE/MVDA)

Education

Ph.D. in Chemical/Bioengineering or related field

Tools

SIMCA

JMP

Job description

Job Description

Job Description: -

The Biologics Process Research & Development organization within our company's Research Laboratories 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 biotherapeutics and efficiently manufacture material to supply clinical trials. We are also responsible for commercial process development and development and implementation of new manufacturing technologies. We work with our partners in our company's Manufacturing Division to commercialize and launch new products.

We are seeking a highly motivated and energetic individual to join our Biologics Process Development Department as an Associate Principal Scientist.- Applicant 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.

In this role, the 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. She/He will also participate in developing and refining strategies related to next-generation processes through technology development initiatives for assets in early and late-stage clinical development.

Responsibilities include, but are not limited to:

• 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 up to date with the external patent and literature environment; actively present and publish externally and pursue patenting strategies.

MINIMUM EDUCATION REQUIREMENTS:-

• Ph.D. with 4+ years' experience or Master's with 8+ years' experience or a bachelor's with 12 years of experience in chemical engineering, Bioengineering, Biological Engineering, or a related field

REQUIRED EXPERIENCE AND SKILLS:

• 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.

PREFERRED EXPERIENCE AND SKILLS:

• 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.

Required Skills:

Biodesign, Biodesign, Biological Engineering, Cell Cultures, Cell Line Development, Cell Physiology, Chemical Engineering, Clinical Trials, Computational Fluid Dynamics (CFD), Detail-Oriented, Downstream Process Development, Drug Delivery Technology, Drug Development, Expression Vectors, Interpersonal Relationships, Leading Project Teams, Mammalian Cell, Mammalian Cell Culture, Manufacturing Processes, Molecular Biology, Operational Efficiency, Pharmaceutical Formulations, Pharmaceutical Process Development, Physical Characterization, Stable Cell Lines {+ 1 more}

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.

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.

Salary range for this role is

$142,400.00 - $224,100.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several 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.

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 .

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

10/1/2026

*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.