USA - New Jersey - Rahway, United States of America
Onsite
Job Description
Job Title: Senior Scientist, Cell Culture Sciences, Biologics Drug Substance Commercialization
Level: R3
Location: Rahway, NJ
Join Our Team as a Biologics Cell Culture Senior Scientist!
Are you ready to take your career to the next level?
We are seeking a strategic and technical scientist with expertise in cell culture development & commercialization to spearhead our ever growing and dynamic late-stage biologics pipeline within the expansive Biologics S&T portfolio.
Why You'll Love This Role:
As a Sr. Scientist in Biologics Cell Culture Commercialization, you’ll be at the forefront of scientific advancement, providing strategic and tactical technical direction through cross-functional partnerships with key business units and customers.
Your participation will be instrumental in supporting DS commercialization, process characterization, control strategy development, tech transfer to internal and external manufacturing sites, process validation, second generation process development and health authority licensure.
You’ll be supporting the charge in transforming our late-stage pipeline into reality bringing lifesaving medicines to our patients worldwide.
Global Impact:
Collaborate with colleagues across the US and internationally to elevate standards in biologics commercialization and manufacturing. Your work will shape the future of biologics on a global scale.
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 knowledge: Fundamental knowledge and subject matter expertise with mammalian cell culture processing of biologics (large molecule products), recent advances, and challenges in the field. Experience 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: Support Cell Culture CMC teams, and align resources to deliver on priorities. 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 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: 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 six (6) years of relevant industry experience. OR
Master's degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with four (4) years of relevant industry experience. OR
Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with a no minimum relevant knowledge.
What You Bring:
Expertise in cell culture commercialization and manufacturing operations
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
Be a Catalyst for Innovation!
If you’re passionate about biologics and ready to lead a high-impact team, apply now and be part of a transformative journey in the world of DS commercialization and biomanufacturing!
Required Skills:
Adaptability, Adaptability, Biological Engineering, Biomanufacturing, Bioreactors, Cell Cultures, cGMP Regulations, Chemical Engineering, Chromatographic Techniques, Clinical Judgment, Cross-Functional Collaboration, Design of Experiments (DOE), Detail-Oriented, Good Manufacturing Practices (GMP), Mammalian Cell Culture, Process Design, Process Optimization, Process Scale Up, Process Validation, Risk Analysis, Risk Assessments, Risk Control Assessment, Small Molecule Synthesis, Stakeholder Communications, Stakeholder Engagement {+ 1 more}Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
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:
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.
Learn more about your rights, including under California, Colorado and other US State Acts
The salary range for this role is
$117,000.00 - $184,200.00This 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.
You can apply for this role through https://jobs.merck.com/us/en (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
Search Firm Representatives Please Read Carefully
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:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
06/23/2026*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.
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