Senior Specialist, Engineering

Job Description

Large Molecule Science and Technology (LMS&T) Technical Product Leadership (TPL) is seeking a highly motivated person for the role of Senior Specialist, Vaccine Technical Product Leadership. This role will provide end-to-end manufacturing science and technology support for MMR, Varivax, ProQuad, and Sterile Diluent (MMRV+SD) across the following sites: West Point, PA, Durham, NC and various packaging and external manufacturing facilities. 

MMRV+SD TPL is a customer-focused global technical support group with the primary goal to partner with key business units and customers to identify and implement innovative technical solutions and operational improvements that promote both process and supply chain robustness across the lifecycle of the product. The Senior Specialist in the MMRV+SD TPL will partner with groups across the Company, including Technical Operations, Operations, Quality, commercialization, process development, Devices, Regulatory-CMC, Supply Chain, and Value Chain.

Key functions:

• Coordinate technical teams across the network to achieve MMRV+SD strategic goals & project portfolio. Apply vaccine product/manufacturing process subject matter expertise to plan and lead complex multi-site investigations and drive above-site/global projects

• Provide on-site support for critical site investigations and specialized technical requests.

• Collaborate and engage with key functional leads within LMS&T, site manufacturing, commercialization, Research Laboratories, device technical ops, and process development/support laboratories to identify and implement opportunities for enhanced process robustness

• Build and maintain strong and trusting relationships with site counterparts, functional management, and other stakeholders to ensure effective communication of plans and issues

• Actively identifies vulnerabilities in end-to-end control strategy to highlight risk and drive mitigating solutions.

• Execution of rigorous proactive process analysis (PPA) plans across the MMRV+SD products

• Use tools & systems to understand & communicate product health (eg process health index, sister site evaluations) and support technical lifecycle management and risk reduction (eg master comparability plans, knowledge management tools).

Education Minimum Requirement:  

• B.S. in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, or related field with six (6) years of relevant experience; or M.S. with four (4) years of relevant experience; or Ph.D. with minimum 2 years of post-doctorate experience

Required Experience and Skills:

• Demonstrated problem solving, effective verbal and written communication, and strong interpersonal skills

• Strong scientific understanding of vaccine and/or biologic products and processes and their effective integration with relevant regulatory/GMP requirements

• Collaborate effectively, across functional boundaries, to align or influence stakeholders and sponsors to provide technical solutions

• Demonstrated leadership and ability to drive results; takes initiative

• Ability to work independently to drive projects to completion; Self-motivated & self-directed

• Ability to travel up to 25% depending upon critical project and site needs

Preferred Experience and Skills:

• Minimum 3 years direct experience in vaccine or biologics process development, commercialization, or manufacturing

• Experience authoring technical documentation

• Experience managing small teams and project teams

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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