Principal Scientist, Upstream Process Development Group Lead

Job Description

Job Description:

Our Scientists are our Inventors. Through innovative thinking state-of-the-art facilities cutting-edge science and technology we collaborate to deliver the next medical breakthroughs. We are looking for a collaborative self-motivated scientific leader with expertise in downstream bioprocessing to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.

As a Senior Principal Scientist/Principal Scientist you will drive various strategic initiatives and translate strategies intoimplementation for our Company biologics platform. You will collaborate with an immensely creative and collaborative team of scientists and engineers to design upstream cell-culture processes while developing technical strategies related to upstream processing and recombinant expression of drug candidates in early- and late-stage development.

Responsibilities include but are not limited to:

• Serve as a scientific leader to shape and drive innovation across the Biologics pipeline strategy and science.

• Anticipate and solve scientific and technical challenges across projects and functional teams in a fast-paced multidisciplinary environment.

• Lead the development of robust and scalable upstream processes for biologics in various stages of clinical development as well as process characterization and regulatory filings for successful commercialization.

• Improve upstream processes by increasing efficiency and cost-effectiveness through research and innovation while evaluating technologies and industry best practices.

• Collaborate with academia industry and vendors to facilitate the development and early adoption of novel process technologies.

• Contribute to strategic initiatives; work with senior leaders to establish overall project strategy and guide teams in its execution.

• Conceptualize plan and execute projects using effective organizational prioritization and problem-solving skills.

• Stay updated on the scientific and regulatory landscape; contribute scientifically and build your reputation through conference participation.

• Represent BPR&D as a upstream bioprocess expert/co-leader in internal and cross-functional project teams.

• Direct supervision of 3-5 scientists accountable for development and growth of a cohesive group and direct reports

• Mentor and actively share expertise across teams; guide career development within and outside the group; build strong collaborative connections in matrix teams

Minimum Education Requirements:

• Ph.D. with 10 years MS with 12 years or BS with 14 and Ph.D. with 6 years MS with 8 years or BS with 10years of industry experience in Chemical/Biochemical Engineering or a related field for Senior Principal Scientist position and Principal Scientist position respectively.

Required Experience Skills and Competencies:

• Strong fundamental knowledge and subject matter expertise in cell-culture process development for biologics fed-batch cell culture bioreactor scale-up and scale-down as well as recent advances and challenges in the field

• Expertise in independently conducting and directing the design execution analysis and documentation of all stages of cell-culture process development

• Track record of accomplishments in upstream bioprocessing with a history of peer-reviewed publications and presentations. Strong understanding of cell metabolism and biochemical pathways relevant to bioprocessing.

• Knowledge of biologics CMC development.

• Ability to adapt to and prioritize complex objectives under tight timelines in a rapidly changing environment.

• Experience leading internal and external cross-functional matrixed teams.

• Demonstrated scientific leadership with significant measurable project impacts across a set of programs.

• Action-oriented mindset with a capacity for creativity; ability to take initiative innovate iterate and solve problems.

• Supervise coach and mentor scientists to maximize talent development and utilization.

• Excellent interpersonal and communication skills.

Preferred Experience & Skills:

• Leadership of CMC development teams.

• Experience with continuous biomanufacturing integrated with process-analytical technologies.

• Knowhow of intensified inoculum and perfusion process development.

• Expertise in media/feed development and relevant chemistry.

• High-throughput experimentation automation and process control.

• Knowledge of microbial fermentation.

• Cell culture predictive modeling (omics (transcriptomics metabolomics or/and proteomics) metabolic flux analysis); statistics data-science machine learning artificial intelligence.

• Process characterization and validation CDMO supervision commercialization of biologics.

Required Skills:

Biologics Bioprocess Engineering Bioreactors Cell Culture Process Development Cell Culture Techniques Cell Line Development Chemistry Combination Products Commercialization Downstream Processing Finite Element Analysis (FEA) Matrix Management Pharmaceutical Process Development Process Development (PD) Process Implementations Quality by Design Regulatory Filings Scientific Presentations Technical Evaluation Technology Development Technology Transfer

Preferred Skills:

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The salary range for this role is

$173200.00 - $272600.00

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 employees 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 can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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

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Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

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Job Posting End Date:

10/10/2026

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