Spclst, Engineering

Specialist, Vaccine Technical Product Leadership

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! Large Molecule Science and Technology (LMS&T) Measles, Mumps, Rubella, Varicella, and Sterile Diluent (MMRV+SD) Vaccine Technical Product Leadership (TPL) is seeking a highly motivated person for the role of Specialist, Vaccine Technical Product Leadership. This role will provide manufacturing science and technology support across the MMRV+SD vaccine sites with a focus on drug substance. The manufacturing sites include West Point, PA and Durham, NC.

MMRV+SD Technical Product Leadership is a customer-focused Above-Site technical support group with the primary focus 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 Specialist, Vaccine Technical Product Leadership will partner with groups across the Company, including Technical Operations, Operations, Quality, commercialization, process development, Regulatory-CMC, Supply Chain, and Value Chain.

Key functions:

• Work Independently and as a Team Member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
• Coordinate technical teams across the network to achieve MMRV+SD Vaccine strategic goals. Participate as a technical expert and/or as a project leader in various projects.
• Ensure process robustness for the MMRV+SD network through Process Monitoring, engaging with site technical teams to identify potential issues and drive rapid resolution.
• Apply vaccine product/manufacturing process Subject Matter Expertise to plan and lead complex multi-site investigations and drive proactive process improvement projects.
• Provide on-site support for critical MMRV+SD vaccine site investigations and specialized technical requests.
• Collaborate and engage with key functional leads within LMS&T, site manufacturing, commercialization, our Research & Development Division and process development/support laboratories to identify and implement opportunities for process improvement and 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.

Education Minimum Requirement:

• M.S. in Engineering or Biology/Chemistry Sciences, or related life sciences/engineering degree.
• B.S. in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with two (2) years of relevant experience; or M.S. in the same fields.

Required Experience and Skills:

• Demonstrated problem solving, effective verbal and written communication, and strong interpersonal skills.
• Strong scientific understanding of vaccine products and processes, and their effective integration with relevant regulatory/GMP requirements.
• Collaborate effectively, across functional boundaries, to align stakeholders and sponsors on technical solutions.
• Demonstrated leadership and ability to drive results.
• Ability to work independently to drive projects to completion.

Preferred Experience and Skills:

• Minimum 2 years direct experience in vaccine drug substance process development, commercialization, or manufacturing.
• Experience in data analytics through building cross-site process monitoring tools, analyzing performance metrics to ensure processes are operating within defined thresholds, and ensuring continuous reliability improvement.
• Experience authoring technical documentation.
• Experience managing project teams.
• Ability to travel up to 10% depending upon critical site needs.

Required Skills: Adaptability, Biochemistry, Change Control Management, Data Analysis, Equipment Troubleshooting, Functional Management, Good Manufacturing Practices (GMP), Immunochemistry, Lean Manufacturing, Microbiology, MUMPS Programming, Oral Communications, Personal Initiative, Process Improvement Projects, Process Improvements, Process Optimization, Product Management Leadership, Professional Integrity, Project Management, Root Cause Analysis (RCA), Stakeholder Management, Technical Writing, Technology Transfer, Vaccine Manufacturing.

Preferred Skills: