Associate Principal Scientist, Upstream Process Development

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

Benefits offered by this job

Medical, dental, vision coverage

401(k) retirement benefits

Paid holidays and vacation

Job summary

Merck & Co. is seeking an Associate Principal Scientist to lead upstream process development for mammalian cell culture and to advance CMC development for our biologics pipeline.

You will collaborate across discovery, cell line, downstream, analytics, and manufacturing to deliver robust, scalable processes and provide scientific leadership. The role emphasizes cross-functional teamwork, mentoring junior staff, and delivering efficient process improvements to support clinical and commercial

Qualifications

• Technical background with mammalian cell culture and fed-batch processes for recombinant proteins.
• Knowledge of CHO cell biology, metabolism, media, and large-scale production systems.
• Experience with design of experiments and multivariate data analysis (e.g., SIMCA, JMP).
• Understanding of bioreactor scale-up from lab to commercial manufacturing.

Responsibilities

• Participates in/upstream process development of first-in-human and commercial processes with high yield, robustness, and scalability.
• Handles process development, characterization, and regulatory filing activities for PPQs and BLAs.
• Collaborates with Discovery, Cell Line, Downstream, Analytics, and Manufacturing to deliver integrated process solutions.

Skills

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

Education

Ph.D. with 4+ years experience

Master's with 8+ years experience

Tools

SIMCA

JMP

Job description

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.

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 current -with the external 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 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:

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

US and Puerto Rico Residents Only:

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:

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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.

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The 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