Merck
Principal Scientist, Cell Culture Sciences, Biologics Drug Substance Commerciali
Merck, West Point, Pennsylvania, us, 19486
Biologics Drug Substance Commercialization Leader
Join Our Team as a Biologics Drug Substance Commercialization Leader! Are you ready to take your career to the next level? We are seeking a strategic and technical leader 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. Reporting directly to the Biologics Cell Culture Commercialization Leader, you will lead a team of approximately 3-5 scientists, who lead multidisciplinary program teams and drive innovation in biologics DS manufacturing and commercialization projects. Why You'll Love This Role: As a Biologics Drug Substance 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 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 sixteen (16) years of relevant industry experience. OR
Master's degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with twelve (12) years of relevant industry experience. OR
Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with minimum eight (8) years of relevant industry experience.
What You Bring: Proven leadership of cross-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
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!
Join Our Team as a Biologics Drug Substance Commercialization Leader! Are you ready to take your career to the next level? We are seeking a strategic and technical leader 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. Reporting directly to the Biologics Cell Culture Commercialization Leader, you will lead a team of approximately 3-5 scientists, who lead multidisciplinary program teams and drive innovation in biologics DS manufacturing and commercialization projects. Why You'll Love This Role: As a Biologics Drug Substance 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 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 sixteen (16) years of relevant industry experience. OR
Master's degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with twelve (12) years of relevant industry experience. OR
Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with minimum eight (8) years of relevant industry experience.
What You Bring: Proven leadership of cross-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
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!