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

Job Description The Development and Commercialization Team (DCT) leader is accountable for delivering a fully integrated stage‑appropriate CMC development and commercialization strategy which yields the target commercial product. The specific role will be responsible for advancing the company's biologics portfolio. Responsibilities Correspondingly, the DCT leader will be responsible for delivering world class outcomes in the following areas: On‑time, end‑to‑end execution of DCT deliverables including robust processes & analytics, an integrated control strategy, successful tech transfer packages, filing and approval, and a robust commercial supply chain to achieve uninterrupted long‑term supply. Lead DCT—critically assess all team deliverables & foster a learning and collaborative environment. Prioritize, interrogate and mitigate risks across all factors that may impact technical, operational & regulatory success or timelines. Analyze and develop innovative solutions to unforeseen circumstances. Ensure the best science and most robust processes are used, working closely with DCRC. As the Product TPL takes ownership for the products' technical processes and associated challenges, proactively prioritize, interrogate and mitigate risks across technical, regulatory and operational factors. Conduct options analysis and provide recommendation to governance for endorsement. Represent CMC and effectively communicate across governance bodies, stakeholders and teams. Drive outcomes/decisions through influence, advocacy, & negotiation with stakeholders. Influence and challenge the product development team's strategy to ensure a robust CMC strategy is achieved. Identify options to balance Speed/Cost/Robustness & achieve target commercial product. Direct the necessary technical reviews, and ensure robust solutions and approaches are developed by working teams supporting the product. Comply with our company's global and regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day‑to‑day activities and all applicable job functions. Work collaboratively to drive a safe and compliant culture. Core Competencies Development and Commercialization Experience: Demonstrated expertise of technical aspects and interdependencies across DS, DP, Device, Packaging, and Analytical, Regulatory, Quality, and Supply Chain from early development through to commercial manufacturing. Deep understanding of connectivity between clinical, CMC, and HH to successfully launch a new product. Technical Depth and Breadth of Experience: 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. Strategic Thinking/Enterprise Mindset: Understands and can articulate the “Big” picture, thinks strategically, and demonstrates a customer orientation. Demonstrated ability to ask the right questions to drive critical conversations to the best decision for the enterprise, considering options which balance speed, cost, and robustness. Challenges team members to think beyond their area of expertise for the broader interests of the company and patients we serve. Problem Solving and Innovative Thinking: Gathers and analyzes data and effectively responds to new or complex situations, developing creative and innovative solutions to solve and mitigate complex problems. Ability to leverage scientific expertise and growth mindset to interrogate data and foster debate within teams to enable innovative and robust problem solving. Ability to Navigate Ambiguity: Operates and provides direction through ambiguity and adapts plans in the face of change, unexpected events, and/or new information. Capable of both directive and consensus facilitation and awareness of when to apply each. Leverages scientific data to make disciplined risk‑based decisions and is capable of discerning between risks worthy of escalation versus typical uncertainty associated with drug development, commercialization, and/or supply. 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 bodies, senior leadership, team members, and individuals with diverse backgrounds. Practitioner of active listening who consistently strives to understand others' perspectives, concerns, and ideas. Collaboration and Teamwork: Creates, leads, and sustains high‑performing teams, fostering an environment of open communication, enabling all team members to contribute their perspectives and collectively resolve issues. Actively builds strong relationships with team members and key stakeholders to promote collaboration and seek robust perspectives. Drives Results through Accountability: Demonstrates effective leadership of team activities to ensure on‑time, end‑to‑end project execution and delivery. Drives accountability within teams to follow through on commitments, provides direct feedback when individuals are not meeting expectations, and closely partners with senior leaders to deliver on priorities. Influence: Ability to persuade and inspire others to take action, make decisions, or change their attitudes and behaviors. Rapidly able to achieve trust with partners, enabling ability to navigate complex organizational dynamics to achieve their goals. Ownership: Exhibits a proactive mindset, a strong sense of initiative, and the willingness to take on challenges and see them through to completion. Fosters a culture of accountability and resiliency within the team or organization and empowers others to take ownership of their roles and responsibilities. Minimum Educational Requirement and Experience Bachelor of Science (BS) Degree in relevant engineering or science fields with fifteen (15) years of relevant experience, or Master of Science (MS) Degree with twelve (12) years of relevant experience, or PhD with ten (10) years relevant experience Required Experience and Skills Strong cross divisional networking skills and capabilities Demonstrated functional and enterprise leadership, ability to influence at all levels of the organization. Strong collaborative skills and the ability to work strategically and in a detail‑oriented framework with all levels of management. Must have 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. Preferred Experience and Skills Experience in Technical product stewardship Demonstrated track record of successfully commercializing multiple large molecule programs across a variety of platforms. Expert knowledge in global regulatory requirements for large molecule commercialization and BLA assembly. Required Skills Capital Management, Change Management, Chemical Process Development, Cross‑Cultural Awareness, Cross‑Functional Leadership, Decision Making, External Manufacturing, GMP Compliance, Innovation, Manufacturing Scale‑Up, Process Improvements, Results‑Oriented, Sterile Filling, Strategic Thinking, Writing Technical Documents Salary 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. Benefits 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 EEO Statement 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. Location & Hiring Policies 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. If you need an accommodation during the application or hiring process, please contact us. 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. Other Compensation and Work Details Employee Status: Regular Relocation: Domestic Visa Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a #J-18808-Ljbffr Merck & Co. Inc