Director, Drug Substance & Cell Banking Leader

Merck • Upper Gwynedd Township, PA

5d • Hybrid

About The Position

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

Requirements

• 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.
• 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.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• Drive project timelines, metrics, resource optimization, and prioritization.
• Champion innovation, digital enablement, modeling‑driven approaches, and data-rich decision making.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree