Job Description

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 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 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:

Preferred Skills:

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US and Puerto Rico Residents Only:

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. 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.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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 in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.