Associate Principal Scientist, Biologics Development

Merck; New Jersey; On-site; USD 180,000 - 260,000; Full time

Job summary

Merck in New Jersey seeks a Biologics Cell Culture Commercialization Leader to guide process development, characterization, tech transfer, and regulatory filings for late-stage biologics. You will drive strategy and lead teams across stages from discovery to licensure.

As a senior leader, you will collaborate cross-functionally with manufacturing, QA, and regulatory groups to ensure robust CMC submissions and successful product commercialization globally.

Qualifications

• Bachelor's degree with eight (8) years of relevant industry experience.
• Master's degree with six (6) years of relevant industry experience.
• Ph.D. with minimum three (3) years of relevant industry experience.

Responsibilities

• Technical Strategy: Deliver robust DS strategies for successful commercialization. Provide technical oversight of cell culture process development, process characterization and regulatory filing activities.
• Technical leadership: Direct planning, execution, analysis, and documentation of all stages of cell culture process commercialization; risk assessment and regulatory submissions.
• CMC RA: Experience supporting/writing regulatory filings (IND, MAA, BLA) and supporting inspections by FDA, EMA, JNDA, TGA.
• Leadership: Establish and mentor Cell Culture CMC teams, align resources, and drive priority delivery.
• Cross-Functional Collaboration: Lead internal and external cross-functional teams to achieve program goals with governance and safety.
• Problem Solving: Remove roadblocks and elevate issues when needed.
• Communication: Foster collaboration and stakeholder engagement across governance bodies.
• Project Management: Drive schedules, set priorities, and monitor metrics in fast-paced environments.
• Recognition: Celebrate team achievements and foster a culture of appreciation.
• Innovation: Lead business improvement initiatives and drive change.

Skills

Biologics

Bioprocessing

CMC Biologics

Commercial Developments

Commercialization

Leadership

Maintenance Supervision

Mammalian Cell Culture

Manufacturing Scale-Up

Mentorship

Regulatory Compliance

Regulatory Processes

Situational Leadership

Education

Bachelor's in Chemical Engineering / Bioengineering / Biological Engineering / related

Master's in Chemical Engineering / Bioengineering / Biological Engineering / related

Ph.D. in Chemical Engineering / Bioengineering / Biological Engineering / related

Job description

Why You\'ll Love This Role:

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.

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 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.

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.

Required 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

Required Skills:

Biologics, Bioprocessing, CMC Biologics, Commercial Developments, Commercialization, Leadership, Maintenance Supervision, Mammalian Cell Culture, Manufacturing Scale-Up, Mentorship, Regulatory Compliance, Regulatory Processes, Situational Leadership

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the b