Associate Principal Scientist, Biologics Development
Merck & Co.
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Benefits offered by this job
Job summary
Merck & Co. seeks a Biologics Cell Culture Commercialization Leader to guide technical direction across DS commercialization, process characterization, tech transfer, and regulatory filings.
You will lead a team of scientists, align cross-functional resources, and drive PPQs, BLAs, and global health authority licensing for late-stage pipeline products. Responsibilities include developing robust cell culture strategies, ensuring compliance, mentoring staff, and partnering with internal and
Qualifications
- 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.
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.
- 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. 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.
Skills
Education
Job description
As a Biologics Cell Culture Commercialization Leader, 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 leadership 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 lead the charge in transforming our late-stage pipeline into reality bringing lifesaving medicines to our patients worldwide.
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.
- 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 elevate 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.
- 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.
- 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
Biologics, Bioprocessing, CMC Biologics, Commercial Developments, Commercialization, Leadership, Maintenance Supervision, Mammalian Cell Culture, Manufacturing Scale-Up, Mentorship, Regulatory Compliance, Regulatory Processes, Situational Leadership
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.
Learn more about your rights, including under California, Colorado and other US State Acts
The salary range for this role is $142,400.00 - $224,100.00
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
We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.
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.
Regular
Domestic
Yes
10%
Not Applicable
1st - Day
No
n/a
09/9/2026
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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