Senior Scientist, Engineering

MSD Malaysia; Rahway (NJ); On-site; USD 117,000 - 184,000; Full time

Job summary

Merck in Rahway, NJ seeks a Senior Scientist in Biologics Cell Culture Commercialization to lead DS strategies and regulatory filings for late-stage biologics. You will direct cross-functional teams, mentor scientists, and drive tech transfer and process validation across global sites.

The role emphasizes strategic and technical leadership, collaboration, and adherence to cGMP in a dynamic, world-spanning biologics program.

Qualifications

• BS in Chemical/Bio/ Biological Eng with 6+ years industry experience.
• MS in related field with 4+ years experience.
• PhD in related field with no minimum knowledge requirement.

Responsibilities

• Deliver robust DS strategies for commercialization.
• Oversee cell culture process development and regulatory filings.
• Lead cross-functional teams and mentor scientists.
• Support tech transfer and process validation.
• Ensure regulatory filings readiness (IND/MAA/BLA).

Skills

Mammalian Cell Culture

Biomanufacturing

cGMP Regulations

Process Validation

Design of Experiments

Process Scale Up

Process Design

Regulatory Filings

Cross-Functional Collaboration

Leadership

Education

PhD in Chemical/Bio/ Biological Eng

MS in related field

BS in Chemical/Bio/ Biol Eng

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.
• Problem Solving: Remove roadblocks, resolve conflicts, and elevate issues when needed.
• Communication: Foster collaboration, ensure transparency, and engage with governance bodies.
• 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.
• Master's degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with four (4) years of relevant industry experience.
• 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!

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}

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

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: EEOC Know Your Rights EEOC GINA Supplement

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.

The salary range for this role is $117,000.00 - $184,200.00 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.

• Medical, dental, vision healthcare and other insurance benefits (for employee and family)
• Retirement benefits, including 401(k)
• Paid holidays
• Vacation
• Compassionate and sick days

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

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: 08/31/2026

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.