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

MSD•Upper Gwynedd Township, PA

8d•$173,200 - $272,600•Hybrid

About The Position

The Development and Commercialization Team (DCT) leader is accountable for delivering an 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, technology-transfer packages, filing and approval, and a commercial supply chain that supports uninterrupted long-term supply. The leader critically assesses team deliverables, fosters a collaborative learning environment, and prioritizes and mitigates risks that could affect technical, operational, regulatory, or timeline outcomes. Working closely with DCRC, the role ensures strong science and robust processes, takes ownership of product technical processes and challenges, evaluates options, and provides recommendations to governance for endorsement. The position represents CMC across governance bodies, stakeholder groups, and teams; influences product-development strategy; and drives decisions through communication, advocacy, and negotiation. The leader directs technical reviews and works with teams to develop robust solutions that balance speed, cost, and robustness. The role also requires compliance with company and regulatory requirements, execution of applicable current Good Manufacturing Practices (cGMP), and collaborative support for a safe and compliant culture. The successful candidate brings broad development and commercialization experience across drug substance, drug product, devices, packaging, analytics, regulatory, quality, and supply chain, along with demonstrated technical leadership, strategic thinking, sound risk-based decision-making, productive communication, collaboration, accountability, influence, and ownership.

Requirements

Bachelor of Science degree in a relevant engineering or science field and 15 years of relevant experience, or a Master of Science degree and 12 years of relevant experience, or a PhD and 10 years of relevant experience.
Strong cross-divisional networking skills and capabilities.
Demonstrated functional and enterprise leadership, with the ability to influence at all levels of the organization.
Strong collaboration skills and the 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, and the ability to manage multiple programs and create a high-performance work environment.
Demonstrated expertise in technical aspects and interdependencies across drug substance, drug product, devices, packaging, analytics, regulatory, quality, and supply chain, from early development through commercial manufacturing.
Deep understanding of the connections between clinical, CMC, and HH to support successful new-product launches.
Recognized technical leadership, including scientific excellence in at least one CMC function and the ability to navigate uncertainty.
Strategic thinking and enterprise mindset, including the ability to evaluate options balancing speed, cost, and robustness.
Strong problem-solving and innovative-thinking capabilities, including gathering and analyzing data and developing solutions to complex problems.
Ability to navigate ambiguity, adapt plans to change, and make disciplined, science-based risk decisions.
Strong communication, active listening, collaboration, influence, accountability, and ownership capabilities.
Skills identified in the posting: biologics, chemical process development, CMC biologics, collaborative leadership, commercialization, cross-functional leadership, decision making, new product launch strategies, organizational leadership, pharmaceutical industry, process improvements, product launches, results-oriented work, strategic thinking, supply chain, team organization, technology transfer, and writing technical documents.

Nice To Haves

Experience in technical product stewardship.
A demonstrated 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 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 continuity.
Critically assess team deliverables, foster a collaborative learning environment, and prioritize and mitigate technical, operational, regulatory, and timeline risks.
Work closely with DCRC to ensure strong science and robust processes are used.
Take ownership of product technical processes and challenges, conduct options analysis, and provide recommendations to governance.
Represent CMC across governance bodies, stakeholders, and teams, and influence product-development strategy and decisions.
Direct technical reviews and ensure working teams develop robust solutions and approaches that balance speed, cost, and robustness.
Comply with company and regulatory requirements and applicable cGMP in day-to-day activities.
Collaborate to promote a safe and compliant culture.
Lead team activities and drive accountability for on-time, end-to-end project execution and delivery.