Talent Program - Global Science, Engineering and Commercialization Co-Op

Job Description

The Future Talent Program features Cooperative (Co-op) education opportunities that last up to 6 months and will include one or more projects. These opportunities in our Manufacturing Division can provide you with great development and a chance to see if we are the right company for your long-term goals.

Global Science, Engineering and Commercialization is responsible for end to end technology support for vaccines and biologics, advancing our growing pipeline of large molecule products while supporting the existing commercial manufacture and expansion. This includes the planning and execution of process development studies to support design & characterization of commercial-scale processes. The organization is also responsible for technology transfer to commercial manufacturing sites.

We support process validation, regulatory approval, and initial launch of our new products.

Biologics Drug Substance Process Development & Commercialization is focused on commercialization of biologic and vaccine drug substances

Sterile Drug Product Commercialization is focused on commercialization of sterile drug products, including biologics, vaccines, and sterile small molecules

Bring chemically or biologically derived research and discoveries to production by applying engineering, chemistry, and pharmaceutics skills to characterize and scale-up bench or pilot-scale processes.

Develop, optimize, and implement innovative manufacturing technologies and analytical methods.

Use process modeling combined with statistical, data analytics, and data science tools to analyze and identify insights from process information.

Support process technology development and transfer to commercial operation groups.

Technical Product Leadership is focused on end to end support of vaccine and biologic products including internal and external nodes, late stage pipeline and commercial products.

Collaborate with operations and quality groups on the execution of strategic projects to ensure a high level of process performance and enhance World Class Supply for commercial products.

Examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve the root cause.

Support the transfer of products within the Company’s internal and external manufacturing network and ensure proper knowledge management.

• Contributes to the performance and results of a department.
• Applies technical skills to align activities with department objectives.
• Designing and executing process development and characterization studies.
• Authoring technical protocols for studies, including ensuring appropriate design of experiments (DoE), sample size selection, and acceptance criteria.
• Managing sample submission and tracking. Employing statistical tools and methods to analyze results
• Authoring technical reports that can be used as source documentation for regulatory filings
• Participation in development and commercial teams (working group/product council)
• Presenting study results and conclusions at team (working group/product council) and department meetings
• Ensuring technical information is clearly understood and integrated into decision making
• Supporting computational modeling work
• Authoring or performing second-person review (SPR) for high-quality regulatory submissions
• Works as a team member on manufacturing investigations, validation activities and/or process improvement projects.
• Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
• Assures consistent application of standardized work, engineering and process tools and procedures.
• Authors and updates technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.
• Supports departmental plans and priorities based on team/department scorecard to address local business, service and operational challenges.
• Identifies and resolves technical and operational problems…