• 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
• Problem Solving: Remove roadblocks, resolve conflicts, and escalate issues when needed
• Communication: Foster collaboration, ensure transparency, and engage with governance bodies
• 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

This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely

• Experience and aptitude to lead, work, and collaborate in internal and external cross-functional, matrixed teams
• Bachelor's degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with eight (8) years of relevant industry experience
• Master's degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with six (6) years of relevant industry experience
• 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
• Be a Catalyst for Innovation!

Accountability, Adaptability, Bioprocessing, Cell Cultures, Chemical Engineering, Cross-Functional Teamwork, Data Analysis, Decision Making, Detail-Oriented, Innovation, Mammalian Cell Culture, Manufacturing Process Validation, Manufacturing Quality Control, Manufacturing Scale-Up, Mentorship, Process Improvements, Project Management, Regulatory Submissions, Risk Management, Stakeholder Engagement, Technical Leadership, Technical Writing, Technology Transfer

$139,600.00 - $219,700.00 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