Overview
Our Company's Vaccines Technical Leadership team within the Global Science and Technology (GSEC) organization is seeking a Director to lead the Pneumococcal Vaccines (PCV) - Development and Commercial Team Leadership (DCT) and the technical product leads. The role provides end-to-end technical product leadership and strategic direction for PCV vaccine products across their lifecycle—from development through commercialization and sustained supply. The Director will lead a team of specialists and collaborate across multiple functions and global manufacturing sites to ensure robust, compliant, and innovative manufacturing science and technology solutions.
Responsibilities
* Serve as the primary technical leader for the PCV franchise, owning the product's technical processes and challenges, proactively managing risks, and driving innovative solutions aligned with business goals.
* Lead the Development and Commercial Team (DCT), accountable to Development Commercialization Review Committee (DCRC) for delivering a fully integrated stage-appropriate development and commercialization strategy for PCV products.
* Critically assess all team deliverables, foster a learning and collaborative environment, prioritize and mitigate risks across technical, operational, and regulatory domains, and develop innovative solutions for unforeseen circumstances.
* Provide strategic technical leadership and project execution for strategic and supply initiatives, partnering with manufacturing sites globally.
* Be responsible for end-to-end technical product leadership and oversight of on-time deliverables including robust processes and analytics, an integrated control strategy, successful tech transfer packages, filings and approvals, and a robust commercial supply chain for launch on time and uninterrupted supply.
* Collaborate with Research Laboratories, Process Development, Commercialization, Operations, Quality, Regulatory-CMC, and Supply Chain teams to ensure seamless technology transfers, process validation, regulatory filings, and product launches.
* Ensure process and assay robustness through continuous monitoring, risk identification, and rapid resolution of technical issues within the manufacturing network.
* Represent CMC interests in governance bodies, influencing cross-functional strategies to balance speed, cost, and robustness for successful product launch and long-term supply.
* Develop and implement Knowledge Management strategies to support regulatory filings and lifecycle management of technical product information.
* Provide on-site technical support for critical projects, complex investigations, and specialized requests at manufacturing sites.
* Foster strong, trusting relationships with site leaders, functional management, and stakeholders to ensure effective communication and alignment.
* Drive a culture of safety, compliance, integrity, and inclusion in all activities.
Core Competencies
* Development & Commercialization Expertise: Understanding of technical interdependencies across Drug Substance, Drug Product, Device, Packaging, Analytical, Regulatory, Quality, and Supply Chain from early development through commercial manufacturing.
* Technical Leadership: Recognized scientific leadership with the ability to navigate uncertainty and deliver favorable outcomes.
* Strategic Thinking: Ability to see the "big picture," ask critical questions, and drive decisions that balance enterprise priorities.
* Problem Solving & Innovation: Skilled in analyzing complex data, fostering debate, and developing creative solutions to technical challenges.
* Ambiguity Navigation: Comfortable operating in uncertain environments, adapting plans, and making disciplined risk-based decisions.
* Communication: Effective at leading complex discussions, influencing stakeholders, and tailoring messages to diverse audiences.
* Collaboration & Teamwork: Builds and leads high-performing teams, promotes open communication, and fosters inclusive environments.
* Results Orientation: Drives accountability and ensures on-time delivery of projects and commitments.
* Influence & Ownership: Inspires action, builds trust, and demonstrates initiative to see challenges through to completion.
Compliance & Culture
* Adhere to our company's global and regulatory requirements and current Good Manufacturing Practices (cGMP).
* Promote a safe, compliant, and inclusive culture within the organization and teams.
Education & Experience
* Bachelor of Science (BS) in Biological Sciences, Chemical Engineering, Biochemical Engineering, Bioengineering, or related field with twelve (12) years of experience; OR
* Master of Science (MS) in Biological Sciences, Chemical Engineering, Biochemical Engineering, Bioengineering, or related field with ten (10) years of experience; OR
* Ph.D. in Biological Sciences, Chemical Engineering, Biochemical Engineering, Bioengineering, or related field with seven (7) years of relevant experience.
Experience & Skills
* Extensive experience in vaccine, biologics, or pharmaceutical industries.
* Strong scientific understanding of vaccine/biologic products and processes integrated with regulatory and GMP requirements.
* Proficiency in technical business processes including Change Control, Deviation Management, and Technical Protocols/Reports.
* Demonstrated problem-solving, communication, and interpersonal skills.
Preferred Experience & Skills
* Experience in pneumococcal vaccine manufacturing or development.
* Experience authoring BLA/MAA regulatory license documents.
* Knowledge of vaccine/chemistry processes (fermentation, purification, formulation, filling, packaging).
* Familiarity with regulatory requirements for vaccine and biologics manufacturing.
* Experience with DMAIC / Lean Six Sigma or equivalent methodologies.
Additional Information
* Current Employees apply HERE
* Current Contingent Workers apply HERE
* US and Puerto Rico Residents Only: accommodation information available on request.
* EEOC statements and rights information are provided as part of the posting; see details for more information.
* Travel: 10%; Hybrid work model in the U.S. with three on-site days per week; some roles require on-site presence per business needs.
* Salary range: $169,700.00 - $267,200.00; eligibility for annual bonus and long-term incentive, if applicable.
Application: 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 is listed in the posting.
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