Merck & Co, Inc

Associate Principal Scientist, Engineering

Merck & Co, Inc • $142K — $224K *
Rahway, NJ 07065In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's, Master's, or Ph.D. in Chemical Engineering, Bioengineering, or related field with relevant experience ranging from three to eight years.
  • Proven leadership experience in biologics development and commercialization.
  • Deep understanding of cell culture processes and manufacturing operations.
  • Strong background in regulatory compliance and submissions (IND, MAA, BLA).
  • Demonstrated ability in risk management and team facilitation.

Responsibilities

  • Deliver cell culture strategies for drug substance commercialization.
  • Provide oversight on process development and regulatory submissions.
  • Manage and mentor the Cell Culture CMC team, promoting creativity and initiative.
  • Collaborate across teams to achieve project objectives; promote diversity and safety compliance.
  • Resolve conflicts and remove obstacles to project success.
  • Communicate effectively with stakeholders and governance bodies.
  • Drive project schedules and adapt to changing priorities.

Benefits

  • Opportunity to lead and innovate in cutting-edge biologics development.
  • Mentorship and career development support for professional growth.
  • Collaborative culture that values diversity and inclusion.
  • Engagement with multiple regulatory agencies and global compliance processes.
Full Job Description
Job Description

Job Title: Associate Principal Scientist, Cell Culture Sciences, Biologics Drug Substance Commercialization

Level: R4

Location: Rahway, NJ (primary)

Key Responsibilities:
  • Technical Strategy: Deliver robust DS strategies for successful commercialization. Provide technical oversight of cell culture 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.
  • Technical leadership: Strong fundamental knowledge and subject matter expertise with mammalian cell culture processing of biologics (large molecule products), recent advances, and challenges in the field. Expertise in independently conducting and directing the planning, execution, analysis, and documentation of all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions.
  • CMC RA: Experience supporting/writing regulatory filings (IND, MAA, BLA) and supporting inspections with multiple agencies (FDA, EMA, JNDA, TGA).
  • Leadership: Establish, manage and support Cell Culture CMC teams, and align resources to deliver on priorities. Manage and mentor a team of scientists specializing in biologics commercialization, serving as the scientific/technical mentor for junior staff. Action-oriented, mindset for creativity; ability to take initiative, innovate, iterate, and problem-solve.
  • Cross-Functional Collaboration: Unite diverse teams to achieve program goals as One Team. Champion compliance and safety; promote a culture of diversity, inclusion, and equity. Experience and aptitude to lead, work, and collaborate in internal and external cross-functional, matrixed teams.
  • Problem Solving: Remove roadblocks, resolve conflicts, and escalate issues when needed.
  • Communication: Foster collaboration, ensure transparency, and engage with governance bodies.Excellent interpersonal and communication skills
  • Project Management: Drive project schedules, set clear priorities, and monitor performance metrics. Adaptability and agility to prioritize and deliver complex objectives, often on tight timelines, in a rapidly changing environment.
  • Recognition: Celebrate team achievements and foster a culture of appreciation.
  • Innovation: Lead business improvement initiatives and leverage your network to drive change.


Education & Experience:
  • Bachelor's degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with eight (8) years of relevant industry experience. OR
  • Master's degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with six (6) years of relevant industry experience. OR
  • Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with minimum three (3) years or relevant industry experience.


What You Bring:
  • Proven leadership of functional teams in biologics development & commercialization
  • Deep expertise in cell culture commercialization and manufacturing operations
  • Strong understanding of regulatory requirements
  • Ability to lead without authority, build trust, and inspire accountability
  • Ethical, resilient, and committed to excellence
  • Skilled in risk management, team facilitation, and strategic planning
  • Experience in commercial manufacturing and CMC development
  • Exceptional communication and stakeholder engagement skills


Required Skills:
Adaptability, Biological Engineering, Biomanufacturing, Bioprocessing, Cell Cultures, Chemical Engineering, Cross-Functional Collaboration, Data Analysis, Decision Making, Detail-Oriented, Mammalian Cell Culture, Manufacturing Process Validation, Manufacturing Quality Control, Manufacturing Scale-Up, Mentorship, Process Improvements, Process Validation, Protein Purifications, Regulatory Submissions, Risk Analysis, Risk Assessments, Risk Control Assessment, Technical Leadership, Technical Writing, Technology Transfer

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Employee Status:
Regular

Relocation:
Domestic

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
06/25/2026
*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.

About Merck & Co, Inc

Schering-Plough Corporation is a major U.S.-based manufacturer of pharmaceuticals. It operates in three segments: Prescription Pharmaceuticals, Animal Health, and Consumer Health Care. Schering-Plough develops products targeting on allergy, cancer, hepatitis, cardiovascular, central nervous system, respiratory system, and more.  It was founded in 1851 by Ernst Christian Friedrich Schering as Schering AG in Germany. Schering-Plough manufactured several pharmaceutical drugs, the most well-known of which were the allergy drugs Claritin and Clarinex, an anti-cholesterol drug Vytorin, and a brain tumor drug Temodar. It also developed drugs targeting on central nervous system and the respiratory system. Schering Plough also owned and operated the major foot care brand name Dr. Scholl's and the skin care line Coppertone. These also became a part of the new company. Schering-Plough was a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA), a membership which is also maintained by the new Merck.

Merck & Co, Inc Careers

Join the visionary team at Merck & Co, Inc, a global leader in healthcare dedicated to advancing the world of medicine. As part of our professional community, you'll find dynamic job opportunities that foster innovation and leadership across various fields. Merck & Co, Inc is not just a company; it's a place where you can make a difference.

Work You’ll Do

At Merck & Co, Inc, we are committed to improving global health through groundbreaking research and innovative healthcare solutions. Our team is at the forefront of developing new therapies and vaccines that significantly impact public health worldwide. By joining us, you will collaborate with some of the brightest minds in the industry, using your skills to contribute to projects that save and improve lives around the globe.

Explore Career Paths

Whether you're seeking an internship, a graduate opportunity, or a professional position, Merck & Co, Inc offers a range of career paths in environments that promote rapid professional growth and development. Explore job opportunities in research, digital transformation, manufacturing, and more, all while benefiting from a culture that supports diversity and inclusion.

Innovate and Lead

Merck & Co, Inc is an ideal environment for those who lead with curiosity and the drive to innovate. Our leadership is committed to fostering a culture where inventive thinking and collaboration are encouraged, making it a perfect place for professionals who seek to make an impact through their work.

Develop Your Skills

With Merck & Co, Inc, you are not just getting a job; you're gaining access to unparalleled career development opportunities. Enhance your skills through diverse training programs, workshops, and continuous learning courses designed to help you grow at every stage of your career.

Benefits and Culture

We understand that our employees are our greatest asset, which is why we offer competitive benefits designed to support the health and well-being of you and your family. From comprehensive health care coverage and retirement plans to flexible working conditions and wellness programs, our benefits package is designed to meet the diverse needs of our team members.

Join Our Team

Ready to advance your career at Merck & Co, Inc? Search open positions that match your skills and interests. We are continuously hiring and looking for passionate, creative, and solution-driven team players. Prepare your resume, sharpen your interview skills, and become part of a company that's dedicated to making a difference.

Stay Connected

Keep up to date with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. Engage with us through our careers blog and by participating in networking events and employment fairs. Subscribe to receive personalized job alerts and the latest news tailored to your preferences. Discover the exciting and rewarding opportunities that await at Merck & Co, Inc. Join us in our mission to improve health and wellness around the world.
Learn more about Merck & Co, Inc
Size
68,000 employees
Market Cap
$282.6 billion
Industry
Pharmaceuticals & Biotech
Net Income
$7 billion
Founded
1668
5 Year Trend
+4.1%
Revenue
$47.9 billion
NASDAQ
MRK
* Ladders Estimates

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