Director - GQ-LMAS - Vaccine Methods Team Lead

Job Description We seek a candidate to lead a team of subject matter experts (SMEs) providing in-depth technical support for vaccine analytical methods as a member of the Global Quality Large Molecule Analytical Sciences – Central Vaccine Labs Team. Analytical testing is critical to the assessment of vaccine product quality, potency, purity, identity, safety, stability, and process consistency. Methods support by this team include bioassays, immunoassays, biophysical methods, chromatography, biochemical and physicochemical methods, characterization methods, and other platform or product-specific assays used for release, stability, investigational, process development, and lifecycle management purposes. This team is highly motivated, fast paced and focused on ensuring consistent compliant supply of our vaccine franchises while advancing analytical lifecycle initiatives. This position will manage subject matter experts across our vaccine franchises, with special emphasis on HPV and PCV, and will provide technical oversight of analytical testing supporting our Company’s inline vaccine products The candidate will be expected to provide guidance, expertise and support for analytical methods established within our commercial laboratories. This support is provided through a network of subject matter experts and partner organizations. The method lead and their team will interface with colleagues in quality laboratories, site-based technical support functions, critical reagent and reference standard hubs, project teams across the company as well as external laboratory partners. This position will require effective collaboration with colleagues in our research laboratories, statistical & modeling groups, process and product development teams, as well as CMC-Regulatory. The lead will be responsible for coordinating the activities of their direct reports using outcome-driven performance plans and ensuring SME support is aligned to franchise priorities and business needs. Effective communication and teamwork are required with both internal and external partners. Global technical support is provided for methods at all internal and external testing sites, and the candidate is expected to foster effective external collaborations working with multiple partners including sourcing and procurement functional areas. Working with colleagues in Global Quality Large Molecule Analytical Sciences, the candidate will be a key partner in analytical lifecycle management activities, helping to identify key components that influence method performance and developing risk abatement strategies. The lead will also directly oversee and/or assist with driving strategies for reference standards, critical reagents, assay controls, method platforms, and other key materials or processes that impact analytical performance and robustness. Key activities supporting the team mission of providing world-class technical support for vaccine testing include: method lifecycle management, reference standard and critical reagent strategy, support of analytical investigations, regulatory submission support, method optimization, assay and method performance monitoring, input on method template designs, coordination of testing strategy, working with partners to optimize workflows, troubleshooting workshops, technical risk assessments, method validation and transfer support, and method modernization activities. The candidate should be a strong technical leader and troubleshooter with broad analytical testing expertise, vaccine franchise experience, and the ability to connect method performance to product quality, regulatory expectations, and business priorities. Education Minimum Requirement: 15 years of industry experience plus a Master’s or Bachelor’s degree or 10 years of industry experience plus a PhD degree working directly in the field of analytical testing, development and/or validation. Required Experience and Skills: Must have a strong Quality control background with demonstrated experience supporting GMP analytical methods, including defending technical content during health authority inspections and writing/reviewing regulatory technical questions. Ability to lead teams demonstrated through 3 key levers: Experience as a direct manager of technical experts, including goal setting, development planning, performance management, financial budget and department resources. Experience as a cross-functional leader with the ability to drive right first-time execution of projects/testing, while maintaining strong relationships and collaborative mindset. Demonstrated examples of driving change across the global environment in a positive way. Demonstrated experience with Analytical Method Validation and relevant compendial guidelines, such as ICH Q2/Q14, as well as analytical tech transfer. 10 + years of analytical testing or development experience with assay validation and troubleshooting expertise across a broad method and portfolio set. Demonstrated ability leading technical teams and mentoring and developing scientific talent. Incumbent must have excellent interpersonal, communication, and collaboration skills. Strength in delivering results on firm deadlines in support of drug/vaccine development and commercialization Broad expertise with vaccine analytical testing, including bioassays, immunoassays, biophysical methods, chromatography, biochemical and physicochemical methods, characterization methods, and other platform or product-specific analytical methods, with preferred experience supporting recombinant and conjugate vaccines. Development and management of project timelines and deliverables. Authoring and reviewing technical documents. Ability to work independently and within a cross-functional team. Required Skills: Ability to Coordinate, Ability to Coordinate, Adaptability, Analytical Method Development, Analytical Thinking, Biologics License Application (BLA), Chromatographic Techniques, Decision Making, Dosage Forms, External Manufacturing, Immunoassays, Laboratory Management, Laboratory Operations, Laboratory Planning, Laboratory Research, Laboratory Techniques, Method Development, People Leadership, People Management, Pharmaceutical Industry, Process Analytical Technology (PAT), Professional Networking, Regulatory Compliance, Regulatory Submissions, Results-Oriented {+ 8 more} 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