Senior Scientist, Bioprocess Drug Substance Commercialization-3

MSD•Upper Gwynedd Township, PA

6d•$117,000 - $184,200•Hybrid

About The Position

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.

Requirements

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.
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
Accountability
Adaptability
Biodesign
Biological Engineering
Cell Cultures
Cell Physiology
cGMP Regulations
Chemical Engineering
Chromatographic Techniques
Clinical Judgment
Data Analysis
Design of Experiments (DOE)
Detail-Oriented
Good Manufacturing Practices (GMP)
Machine Learning (ML)
Mammalian Cell
Mammalian Cell Culture
Primary Cell Culture
Process Characterization
Process Design
Process Optimization
Process Scale Up
Risk Assessments
Risk Consulting

Responsibilities

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.
Independently conduct and direct the planning, execution, analysis, and documentation of all stages of cell culture process commercialization.
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.
Unite diverse teams to achieve program goals as One Team.
Champion compliance and safety; promote a culture of diversity, inclusion, and equity.
Remove roadblocks, resolve conflicts, and escalate issues when needed.
Foster collaboration, ensure transparency, and engage with governance bodies.
Lead business improvement initiatives and leverage your network to drive change.