Senior Specialist, Engineering- Technical Lead for Live Virus Vaccine (LVV)

Merck KGaA Darmstadt Germany • West Point, PA

121d • $114,700 - $180,500 • Onsite

About The Position

Vaccines tech product leadership (V-TPL) within large molecule science and technology (LMS&T) is seeking a highly motivated individual for the role of Sr. Specialist, 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 a Sr. Specialist to join our Live Virus Vaccine (LVV) team. The successful candidate will provide technical 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 implementation of innovative technical solutions and operational improvements to achieve targets for safety, compliance, supply, and productivity for the product franchise. This role requires a strong technical mindset, the ability to support and coordinate technical workstreams, and effective cross-functional communication skills to support global vaccine manufacturing and continuous improvement initiatives.

Requirements

• B.S. in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field, plus minimum five (5) years of relevant experience.
• Alternatively, M.S. with minimum three (3) years of relevant experience, or Ph.D. with relevant experience.
• Demonstrated problem-solving skills; effective verbal and written communication.
• Foundational scientific understanding of vaccine and/or biologic products and processes and their effective integration with relevant regulatory/GMP requirements.
• Demonstrated leadership experience on projects and/or teams.
• Proficiency with pharmaceutical industry technical business processes such as: technical documentation, change control, portfolio management, risk mitigation, deviation management, technical protocols/reports, and BLA/MAA regulatory license documents.
• Strong ability to collaborate and support teams across functional boundaries toward common goals.
• Ability to travel up to 10% in support of critical site needs.

Nice To Haves

• Minimum two (2) year in a technical role with direct experience in LVV process or analytics in process development, commercialization, or manufacturing support.

Responsibilities

• Contribute technical expertise, and become a subject matter expert, in process and analytics to support end-to-end manufacturing science and technology for LVV products.
• Monitor site-specific and cross-site issues, help identify trends, and participate in the implementation of risk mitigation actions.
• Collaborate with functional teams to contribute to strategic workstreams, knowledge sharing, and process improvement projects.
• Support projects through all phases including project planning, project management and execution.
• Provide global technical support for strategic initiatives, projects, and/or investigations including: authoring of technical documentation, process justifications, data analysis, process monitoring, site comparisons and technical risk assessments.
• Facilitate technical forums and help maintain product historical knowledge and best practices.
• Assist with complex process investigations, coordinating and supporting project activities under the guidance of project leads.
• 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.
• Assist in monitoring process performance and participate in data-driven improvement initiatives under the direction of senior team members.
• Support preparation of submission packages, assist in addressing regulatory technical queries, and contribute technical expertise during regulatory inspections as part of a team.

Benefits

• Medical, dental, vision healthcare and other insurance benefits (for employee and family)
• Retirement benefits, including 401(k)
• Paid holidays, vacation, and compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree