Principal Scientist, Upstream Development

Merck

Rahway (NJ)

On-site

USD 173,000 - 273,000

Full time

12 days ago

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Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement plan

Paid holidays and vacation

Job summary

Merck in Rahway, NJ is seeking a Principal Scientist for Upstream Development to shape next-generation cell culture processes for early- and late-stage programs. The role demands leadership, data-driven strategy, and strong cross-functional collaboration to deliver robust, scalable solutions.

Responsibilities include directing process development for FIH and commercial scales, mentoring junior scientists, and driving innovations with external partners. A Ph.D.

Qualifications

Proven record of upstream process and technology development.
Experience in CHO fed-batch cell culture and analytics.
Hands-on experience with cell culture bioreactors at multiple scales.
Knowledge of cell culture media, DOE statistics and CFD.
Ability to plan, execute, analyze and document cell culture process development.
Ability to work in a matrixed team and collaborate with partners.

Responsibilities

Lead upstream biologic process development for FIH and commercial processes.
Provide technical direction for process development, characterization and regulatory filings.
Advance upstream platform strategy and lead process-improvement initiatives.
Initiate collaborations to evaluate new technologies and industry strategies.
Collaborate with academia, industry partners, and vendors to drive innovations.
Stay updated with external literature and pursue patent strategies.
Supervise, coach and educate junior scientists.

Skills

Cell culture process development

Biologics upstream development

DOE statistics

CFD

Mammalian cell culture

Scale-up / tech transfer

Cross-functional leadership

Mentoring

Data science for bioprocess

Education

Ph.D. in Chemical Engineering / Bioengineering / Biochemistry or related

Master's degree in related field

Bachelor's degree in related field

Tools

Bioreactors

Bench-scale bioreactors

Pilot-scale bioreactors

Job description

Job Description

USA - New Jersey - Rahway

The Biologics Process Research & Development organization within our Company 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 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 Manufacturing Division to commercialize and launch new products.

We are seeking a highly motivated and experienced individual to join our Upstream Development Department as a Principal Scientist. In this role, the successful candidate will work closely with scientists in the Upstream Development Department to develop and refine technical strategy related to next generation processing for assets in early- and late-stage clinical development. Applicants must have effective organizational and multi-tasking skills, demonstrated excellent scientific leadership, and superior written and oral communications abilities. A track record of leveraging data science and digital tools for delivering impactful solutions to complex problems are distinguishing. Evidence of strong cross-functional collaboration, experience successfully mentoring junior scientist, leading projects, and strong external presence through scientific excellence are expected.

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. She/He 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 up to date with the external patent and literature environment; actively presents and publishes externally and pursues patenting strategies.
Supervising, coaching and educating junior scientists

Minimum Education Required:

Ph.D. with 8+ years of industry experience, Master with 10+ years industry experience, bachelor's with 14+ years industry in Chemical Engineering, Bioengineering, Biochemistry or a related field

Required Experience And Skills

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.
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 early- and late-stage commercial process development, technology transfer, scale-down model qualification and process characterization.
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:

Adaptability, Adaptability, Biodesign, Cell Culture Process Development, Cell Cultures, Cell Line Development, Chemical Engineering, Clinical Supplies Management, Clinical Trials, Combination Products, Computational Fluid Dynamics (CFD), Data Analysis, Finite Element Analysis (FEA), Flux Analysis, Immunochemistry, Innovative Thinking, Leadership Mentoring, Mammalian Cell Culture, Manufacturing Processes, Media Development, Pharmaceutical Process Development, Professional Collaboration, Professional Networking, Quality by Design, Regulatory Filings {+ 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 Aff…

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

$173,200.00 - $272,600.00

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