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 that yields the target commercial product and actively advances the company’s biologics portfolio. Responsibilities 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, 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, take ownership of the product’s technical processes and associated challenges, prioritize, interrogate and mitigate risks across technical, regulatory and operational factors, conduct options analysis and provide recommendations to governance for endorsement. Represent CMC, communicate effectively across governance bodies, stakeholders and teams, drive outcomes/decisions through influence, advocacy and negotiation, 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, and direct necessary technical reviews to develop robust solutions. Comply with the company’s global and regulatory requirements and execute current Good Manufacturing Practices (cGMP) in 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 in 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 launch a new product. Technical Depth and Breadth of Experience: Credible technical leader with scientific excellence in at least one CMC function and ability to navigate uncertainty to favorable outcomes. Strategic Thinking/Enterprise Mindset: Understands the “big” picture, thinks strategically, demonstrates customer orientation, asks the right questions to drive critical conversations, and balances speed, cost, and robustness to benefit the enterprise and patients served. Problem Solving and Innovative Thinking: Gathers and analyzes data, responds to new or complex situations, develops creative solutions, leverages scientific expertise and growth mindset to interrogate data and foster debate for robust problem solving. Ability to Navigate Ambiguity: Operates and directs through uncertainty, adapts plans amid change or new information, applies directive or consensus facilitation appropriately, and makes risk‑based decisions on relevant risks vs typical uncertainty. Productive Communication: Plans and delivers ideas to diverse audiences, leads discussions, influences stakeholders, tailors communications, and actively listens to understand others’ perspectives. Collaboration and Teamwork: Builds and sustains high‑performing teams, fosters open communication, and promotes collaboration to seek robust perspectives. Drives Results through Accountability: Leads team activities to ensure on‑time, end‑to‑end project delivery, holds teams accountable, provides feedback, and partners with senior leaders to deliver priorities. Influence: Persuades and inspires action, facilitates trust with partners, and navigates complex dynamics to achieve goals. Ownership: Proactive mindset, strong initiative, and willingness to take challenges through completion while empowering others to own roles and responsibilities. Minimum Educational Requirement And Experience Bachelor of Science (BS) with fifteen (15) years of relevant experience. Master of Science (MS) with twelve (12) years of relevant experience. Ph.D. with ten (10) years of relevant experience. Required Experience And Skills Strong cross‑divisional networking skills and capabilities. Demonstrated functional and enterprise leadership, ability to influence at all levels. Strong collaborative 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, 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. 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 and Benefits The salary range for this role is $173,200.00 – $272,600.00. The successful candidate will be eligible for an annual bonus and long‑term incentive, if applicable. We offer a comprehensive package of benefits, including 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. Equal Employment Opportunity 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 and 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. #J-18808-Ljbffr MSD Ireland