Director, Biologics Development and Commercialization Team Lead (CMC Team Lead)

Merck•Upper Gwynedd Township, PA

8d•$173,200 - $272,600•Hybrid

About The Position

The Development and Commercialization Team (DCT) leader is accountable for delivering a fully integrated, stage-appropriate CMC development and commercialization strategy that yields the target commercial product. This role advances the company's biologics portfolio and leads end-to-end execution of DCT deliverables, including robust processes and analytics, an integrated control strategy, successful technology transfer packages, filing and approval, and a robust commercial supply chain to support uninterrupted long-term supply. The DCT leader critically assesses team deliverables, fosters a collaborative learning environment, and prioritizes and mitigates risks that could affect technical, operational, or regulatory success and timelines. The role works closely with DCRC and the Product TPL, drives technical reviews, develops options and recommendations for governance, and represents CMC across governance bodies, stakeholders, and teams. The leader influences product development strategy and balances speed, cost, and robustness to achieve the target commercial product. The role requires compliance with company and regulatory requirements, including current Good Manufacturing Practices (cGMP), and collaborative leadership in support of a safe and compliant culture. The position is based in West Point, Pennsylvania, with a hybrid work arrangement and 10% travel. Domestic relocation is available; visa sponsorship is not offered.

Requirements

Bachelor of Science in a relevant engineering or science field with 15 years of relevant experience, or Master of Science with 12 years, or PhD with 10 years.
Strong cross-divisional networking skills and capabilities.
Demonstrated functional and enterprise leadership, including the ability to influence at all organizational levels.
Strong collaborative skills and ability to work strategically and in a detail-oriented framework with all levels of management.
Strong understanding of product management systems and tools.
Strong business and financial skills.
Ability to manage multiple programs and create a high-performance work environment.
Expertise in technical aspects and interdependencies across drug substance, drug product, device, packaging, analytical, regulatory, quality, and supply chain, from early development through commercial manufacturing.
Deep understanding of the connections between clinical, CMC, and human health to support successful new product launches.
Recognized technical leadership, with scientific excellence in at least one CMC function and ability to navigate uncertainty.
Strategic and enterprise-oriented thinking, including ability to assess options that balance speed, cost, and robustness.
Strong problem-solving, innovative thinking, and ability to analyze data and address complex or changing situations.
Ability to navigate ambiguity, adapt plans, make disciplined risk-based decisions, and distinguish risks for escalation from typical development uncertainty.
Effective communication, including leading complex discussions, influencing stakeholders, tailoring communications to different audiences, and active listening.
Ability to build and sustain high-performing teams, foster open communication, and develop stakeholder relationships.
Results orientation, accountability, influence, initiative, ownership, and resilience.

Nice To Haves

Experience in technical product stewardship.
Track record of successfully commercializing multiple large-molecule programs across a variety of platforms.
Expert knowledge of global regulatory requirements for large-molecule commercialization and BLA assembly.

Responsibilities

Deliver an integrated, stage-appropriate CMC development and commercialization strategy for the company's biologics portfolio.
Lead on-time, end-to-end execution of DCT deliverables, including processes and analytics, control strategy, technology transfer packages, filing and approval, and commercial supply chain readiness.
Lead the DCT, critically assess team deliverables, and foster a learning and collaborative environment.
Prioritize, assess, and mitigate technical, operational, and regulatory risks that could affect success or timelines.
Work closely with DCRC to ensure the use of appropriate science and robust processes.
Take ownership of product technical processes and challenges, conduct options analyses, and provide recommendations to governance for endorsement.
Represent CMC and communicate across governance bodies, stakeholders, and teams; influence, advocate, negotiate, and drive decisions and outcomes.
Influence and challenge product development strategy to ensure a robust CMC strategy, balancing speed, cost, and robustness.
Direct technical reviews and ensure working teams develop robust solutions and approaches.
Comply with company and regulatory requirements and execute cGMP in day-to-day activities and applicable job functions.
Collaborate to promote a safe and compliant culture.
Lead teams to deliver on-time, end-to-end project execution, drive accountability, provide direct feedback, and partner with senior leaders on priorities.