Associate Principal Scientist, Biologics Development

Merck•Rahway, NJ

1d•$142,400 - $224,100•Onsite

About The Position

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.

Requirements

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

Nice To Haves

Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: 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
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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.
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.
Experience supporting/writing regulatory filings (IND, MAA, BLA) and supporting inspections with multiple agencies (FDA, EMA, JNDA, TGA).
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.
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.
Remove roadblocks, resolve conflicts, and escalate issues when needed.
Foster collaboration, ensure transparency, and engage with governance bodies.
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.
Celebrate team achievements and foster a culture of appreciation.
Lead business improvement initiatives and leverage your network to drive change.