Director, Small Molecule- Technical Product Leader (TPL)

Merck; Rahway (NJ); On-site; USD 180,000 - 280,000; Full time

Job summary

Merck is seeking a Director, Technical Product Leader (TPL) in the Small Molecule Science and Technology group within Manufacturing. This leader will guide late-stage development to launch, overseeing the Development Commercialization Team (DCT) and ensuring seamless tech transfer, regulatory filings, and a robust supply chain.

The role requires strategic thinking, risk management, and strong cross-functional collaboration across CMC, Regulatory, Quality, and Supply Chain to achieve on-time,

Qualifications

• Experience leading cross-functional teams in drug development and commercialization.
• Strong strategic thinking and risk management in late-stage programs.
• Ability to communicate with governance bodies and stakeholders.
• Deep understanding of CMC, regulatory, and supply chain concepts.

Responsibilities

• Lead the Development Commercialization Team (DCT) to deliver stage-appropriate plans.
• Assess deliverables, mitigate risks, and ensure timely tech transfer and filings.
• Represent CMC in governance, influence strategies, and drive decisions.
• Oversee VCMT deliverables and launch readiness for uninterrupted supply.

Skills

Technical depth

Strategic thinking

Problem solving

Leadership

Communication

Job description

Job Description

The Director, Technical Product Leader (TPL) Leadership position in the Small Molecule Science and Technology (SM S&T) organization within our Manufacturing Division is a full-time role and is accountable for leading the Development Commercialization Team (DCT) at Line of Sight to Commercial Product Definition. This pivotal role encompasses both technical, execution and strategic responsibilities, as it entails guiding drug product candidates from late-stage development to launch and transition to supply, and subsequently as TPL supporting Value Chain Management Team (VCMT) in realization of product lifecycle strategy, in line with enterprise priorities.

• Accountable to the Development Commercialization Review Committee (DCRC) for delivering a fully integrated stage-appropriate development and commercialization strategy which yields the target commercial product.
• Leads the cross-functional DCT, critically assessing all team deliverables & fostering a learning and collaborative environment. Prioritizes, interrogates, and mitigates risks across all factors that may impact technical, operational & regulatory success or timelines. Analyzes and develops innovative solutions to unforeseen circumstances.
• Responsible for end-to-end technical product leadership (TPL) and oversight of the on-time execution of DCT deliverables inclusive of robust processes & analytics, an integrated control strategy, successful tech transfer packages, filing and approval, and a robust commercial supply chain to achieve launch on time and uninterrupted long-term supply.
• Represents CMC and effectively communicates across the governance bodies, stakeholders, and team to drive outcomes/decisions through influence, advocacy, & negotiation with an enterprise mindset. As the CMC representative, influences and challenges the xDT strategy to ensure a robust CMC strategy is achieved. Identifies options to balance Speed/Cost/Robustness & achieve target commercial product.
• Responsible for end-to-end technical product leadership (TPL) and oversight of the on-time execution of VCMT deliverables inclusive of new nodes and filings.

Core Competencies Required For The Role

Technical Depth and Breadth: Exhibits the necessary technical depth and breadth to add substantial value to the business. Recognized as a credible technical leader through demonstrated scientific excellence in at least one CMC function and ability to navigate through uncertainty to favorable outcomes. Demonstrated expertise of technical aspects and interdependence across Drug Substance, Drug Product, Analytical, Device, Packaging, Regulatory, Quality, and Supply Chain from early development through life cycle of the program. Deep understanding of connectivity between clinical, CMC, and HH to successfully launch a new product.

Strategic Thinking/Enterprise Thinking: Understands and can articulate the "big" picture, thinks strategically, and demonstrates customer orientation. Demonstrated ability to know how to ask the right questions to drive critical conversations to the best decision for the enterprise, considering options which balance speed, cost, and robustness. Capable of asking the right questions to drive critical conversations to the best decision for the enterprise, considering options which balance speed, cost and robustness. Challenges DCT and VCMT members to think beyond their functional areas for the broader interests of the company and the patients we serve.

Problem Solving: Gathers and analyzes data and effectively responds to new or complex situations, developing creative and innovative solutions to solve and mitigate problems. Leverages scientific expertise and growth mindset to interrogate data and fosters scientific debate within teams to enable innovative and robust problem solving. Approaches problem solving and project progression logically and in alignment with overall business needs. Able to operate and provide direction through ambiguity and adapt plans in a face of change, unexpected events, or new information.

Drive Results through Accountability: Demonstrates effective leadership of team activities to ensure on-time, end-to-end project execution and delivery. Holds self and team to high standards. Drives accountability on team to follow through on commitments, provides direct feedback when individuals/governance is not meeting expectations, and partners with functional leaders to develop team members as well as to deliver on program milestones. Creates and leads a high performing team, develops team members by working closely with functional leaders.

Decision-Making, Risk Management and Navigating Ambiguity: Demonstrates skill in both directive and consensus-based decision-making, with sound judgment about when each approach is appropriate. Effectively navigates situations with inherent uncertainty, leveraging scientific data to make disciplined, risk-based decisions. Identifies, prioritizes, mitigates, communicates and manages risks in a phase-appropriate manner, while distinguishing between risks that warrant escalation and the typical uncertainty inherent in drug development, commercialization and/or supply. Provides