Associate Director, Engineering- Technical Lead for Live Virus Vaccine (LVV)

Job Description

Vaccines tech product leadership (V-TPL) within large molecule science and technology (LMS&T) is seeking a highly motivated individual for the role of Assoc. Director, Engineering.  This role will provide end-to-end support of manufacturing science and technology for commercial vaccine products including Drug Substance, Drug Product, and Analytics. 

We are seeking an Assoc. Director to join our Live Virus Vaccine (LVV) team. The successful candidate will provide technical leadership and support for LVV franchises, with potential to support ERVEBO and/or Rotateq, collaborating with manufacturing sites in West Point, PA; Wilson, NC; and Burgwedel, Germany. The successful candidate will partner with the team Technical Product Leader as well as site Technical Operations and other key members of the Technical Product Council to implement the prioritized portfolio of projects in support of the franchise strategic goals.  This will include leading implementation of innovative technical solutions and operational improvements to achieve targets for safety, compliance, supply, and productivity for the product franchise. This role requires outstanding technical problem solving, project leadership, and cross-functional communication skills to support global vaccine manufacturing and continuous improvement initiatives.

Responsibilities

• Serve as a technical subject matter expert, providing end-to-end manufacturing science and technology support for LVV products.

• Monitor site-specific and cross-site issues, identify trends and participate in proactively implementing risk mitigation actions.

• Collaborate with functional teams to contribute to strategic workstreams, knowledge sharing, and process improvement projects. Lead projects through all phases including project planning, project management and execution.

• Provide global technical support for strategic initiatives, projects, and/or investigations including:  authoring and approving technical documentation, process justifications, data analysis, process monitoring, site comparisons and technical risk assessments.

• Facilitate technical forums and maintenance of product historical knowledge and best practices.

• Lead complex process investigations, including multi-site coordination and technical project management.

• Support technical teams and foster strong relationships across the vaccine manufacturing network: build and maintain strong and trusting relationships with site technical operations, quality, regulatory, stability, and other stakeholders to ensure effective communication of plans and resolution of issues.

• Collaborate with commercialization and internal/external manufacturing sites to enable on-time, right-first-time vaccine technology transfers as needed.

• Monitor for process performance, assess product technical risks across supply chain, and lead data-driven improvement initiatives.

• Ensure readiness of E2E submission packages, proactive mitigation of regulatory technical queries, and contribute technical expertise during regulatory inspections.

Position Qualifications

• B.S. in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field, plus minimum eight (8) years of relevant experience.

• Alternatively, M.S. with minimum six (6) years of relevant experience, or Ph.D. with minimum (4) years of postdoctoral experience.

Required Experience & Skills

• Demonstrated problem-solving skills; effective verbal and written communication

• Deep scientific understanding of vaccine and/or biologic product process or analytics, and integration with regulatory/GMP requirements.

• Demonstrated leadership experience on projects and teams

• Strong technical problem-solving and effective verbal and written communication skills.

• Proven leadership with the ability to motivate and coordinate diverse cross-functional teams toward common goals.

• Proficiency with pharmaceutical industry technical business processes including:  technical documentation, change control, portfolio management, risk mitigation, deviation management, technical protocols/reports, and BLA/MAA regulatory license documents. 

• Proven ability to collaborate and lead teams across functional boundaries toward common goals.

• Ability to travel up to 10- 20% in support of critical site needs.

Preferred Experience & Skills

• Minimum four (4) years in a technical role with direct experience in LVV process or analytics in process development, commercialization, or manufacturing support.