Job Description
Lead at the Center of Biologics Commercialization Excellence
We are seeking a dynamic, visionary, enterprise-minded leader to serve as our Director, Drug Substance & Cell Banking Leader -a highly influential role embedded on the Biologics Drug Substance Commercialization (BDSC) Leadership Team .
This is more than a cell banking leadership position. As a member of BDSC LT, you will shape and drive the technical strategy, scientific rigor, and ways-of-working across the entire Biologics Drug Substance portfolio, helping position our organization as the commercialization powerhouse needed to deliver our company's expanding and transformative biologics pipeline.
If you thrive at the intersection of science, strategy, leadership, and enterprise impact , this is your role.
Why This Role Is Exceptional
You will shape the future of our Bio DS commercialization ecosystem.
Beyond leading all Cell Bank-related technical work, you will influence end-to-end upstream, downstream, modeling, risk management, and technical strategy across our global Biologics DS network.
You will operate at the highest levels of the BDSC organization.
As a member of BDSC LT , you will collaborate with senior technical and functional leaders, directly shaping our technical agenda, ways of working, and organizational strategy.
You will exemplify our company's Leadership with Purpose model.
This role demands a leader who:
Shapes the Future through entrepreneurship, strategic foresight, talent growth, and decisive technical leadership.
Unlocks Potential by mentoring, developing, and elevating teams; fostering inclusion; and building strong cross-functional partnerships.
Delivers Impact by driving execution excellence, championing innovation, owning decisions, inspiring teams, and serving as a catalyst for change.
You will lead a highly skilled and deeply committed team.
Your team and extended network will look to you as the enterprise role model of excellence, collaboration, accountability, and scientific rigor .
Global Scope & Strategic Impact
In this role, you will:
Oversee the strategy, execution, and governance of Biologics Cell Banking -from manufacturing to characterization, testing, qualification, and regulatory filing.
Drive DS & Cell Bank commercialization across internal and global CMO sites.
Ensure robust tech transfer, strong control strategies, and readiness for PPQ, licensure, and launch.
Influence DS technical strategy across all biologics programs, ensuring scientific rigor and standardization across the network.
Build and maintain global partnerships across Bioprocess R&D, Tech Ops, Quality, Regulatory, External Manufacturing, Analytical, and more.
Key Responsibilities
Strategic & Technical Leadership
Define and deliver robust DS & cell bank strategies that ensure right-first-time commercialization, PPQ, and BLA readiness.
Provide high-level oversight of process development, process characterization, risk assessments, comparability, and regulatory submissions.
Direct Cell Banking working groups and shape network-wide best practices.
Enterprise & Functional Leadership
Serve as a core member of the BDSC Leadership Team , influencing portfolio-level decisions and cross-functional alignment.
Model exceptional enterprise behaviors-collaboration, communication, mindset, adaptability, and purpose-driven leadership.
Mentor, coach, and grow scientific talent, cultivating a high-performance culture grounded in excellence and inclusion.
Regulatory & CMC Leadership
Lead or support authoring for IND, BLA, MAA, and other global submissions.
Support regulatory inspections and represent Cell Banking and DS commercialization with confidence and expertise.
Cross-Functional Integration
Work seamlessly across internal/external technical teams, CMOs, governance bodies, and senior leadership forums.
Remove barriers, anticipate risks, and ensure transparency, alignment, and decisive execution.
Operational Execution & Continuous Improvement
Drive project timelines, metrics, resource optimization, and prioritization.
Champion innovation, digital enablement, modeling-driven approaches, and data-rich decision making.
Education & Experience
Ph.D. + 8 years, Master's + 12 years, or Bachelor's + 16 years of relevant experience in biologics technical development, manufacturing, or commercialization.
Demonstrated leadership in DS or cell culture-based programs, including tech transfer, control strategy, characterization, validation, and regulatory submissions.
What You Bring
Proven leadership and influence in highly matrixed environments.
Deep SME expertise in mammalian cell culture and cell banking operations.
Strong understanding of DS commercialization and CMC regulatory expectations.
Ability to lead without authority, inspire accountability, and elevate team performance.
Excellent communication, strategic thinking, and stakeholder engagement.
Resilience, creativity, integrity, and a relentless commitment to scientific excellence and patient impact.
Be the Leader Who Shapes the Future of Biologics
If you're inspired to lead at an enterprise level-building world-class capabilities, shaping technical strategy, developing exceptional people, and driving meaningful global impact-we invite you to apply.
This is your opportunity to leave a lasting mark on our company's biologics future.
Required Skills:
Analytical Thinking, Analytical Thinking, Cell Cultures, Clinical Manufacturing, Commercialization, Customer Experience Management, Driving Continuous Improvement, Employee Development, Entrepreneurship, Good Manufacturing Practices (GMP), Leadership, Maintenance Supervision, Mammalian Cell, Mammalian Cell Culture, Management Process, Manufacturing Equipment, Operational Execution, Organizational Strategy, People Leadership, Pharmaceutical Process Development, Primary Cell Culture, Production Process Development, Regulatory Compliance, Regulatory Submissions, Resource Management {+ 5 more}
Preferred Skills:
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\EEOC\KnowYourRights\10\20.pdf)
EEOC GINA Supplement?
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.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. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The salary range for this role is
$173,200.00 - $272,600.00
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:
Regular
Relocation:
Domestic
VISA Sponsorship:
Yes
Travel Requirements:
25%
Flexible Work Arrangements:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
03/3/2026
*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.
Requisition ID: R386598
