About this role
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. As Technical Product Leader (TPL) in our Manufacturing Division, the leader is: 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 the 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 clear direction in ambiguous environments and adapts plans in response to change, unexpected events and new information. Productive Communication: Plans and delivers ideas and information to others in an impactful manner with proven ability to lead complex discussions, influence stakeholders, and drive outcomes in the best interest of the enterprise. Capable of tailoring communications to diverse audiences, including governance, senior leadership, team members, and individuals with business and technical backgrounds.
Collaboration and Team Work : Creates and leads a high performing team, fostering an environment of open communication, enabling team members to contribute their perspectives and collectively resolve issues. Challenges team members to think beyond their functional areas for the broader interests of the company and the patients we serve. Act with Urgency: Works with appropriate speed, rigor, and determination to deliver on our pipeline and enable a reliable compliant supply while setting performance standards, holding others & self-accountable, and leveraging the escalation process.
Minimum Education Requirements: Bachelor’s degree in science or engineering related discipline with 10 or more years of experience, or an Advanced degree with 7 or more years of experience Required Skills: Cross-Functional Leadership, Decision Making, Drug Product Manufacturing, External Manufacturing, GMP Compliance, Innovation, Manufacturing Scale-Up, Process Improvements, Product Management Leadership, Regulatory CMC, Results-Oriented, Small Molecules, Stakeholder Engagement, Strategic Thinking, Supply Chain Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE 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 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 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 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: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 09/8/2026 *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.