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Process Transfer Coordinator
2 months ago
Position Summary:
The Process Transfer Coordinator will facilitate collaboration between Operations and the Development, Regulatory, and Project teams at Roche, focusing on the launch of new Assays, Reagents, and Bulk materials utilized in tissue diagnostics.
Key Responsibilities:
- Ensure that all operational requirements are addressed from perspectives of manufacturability, quality, cost, and scheduling.
- Apply program management skills, lean manufacturing principles, and process engineering to successfully integrate new Assays, Reagents, and Bulk materials into existing manufacturing workflows.
- Communicate project risks effectively and propose strategies to mitigate these risks, ensuring the development of a minimum viable product.
Specific Duties:
1. Understand and relay manufacturing best practices, ensuring core project teams are informed of minimum requirements for manufacturability and scalability.
2. Act as the primary Operations contact, ensuring all stakeholders' needs are communicated throughout the transfer process.
3. Continuously improve the transfer process by applying Technology Transfer standard work.
4. Utilize project management techniques to plan, monitor, and ensure timely completion of transfer initiatives.
5. Develop expertise in site manufacturing processes to enhance GMP practices and ensure successful transfer activities regarding cost, quality, and delivery.
6. Incorporate manufacturing requirements into development projects to facilitate robust technical transfers by providing input during the design phase.
7. Execute validation protocols with support from fellow Technical Transfer Specialists, adhering to Good Manufacturing Practices (GMP) and standards for transferred products.
8. Collaborate with cross-functional teams to meet the needs of technology transfer projects.
Additional Responsibilities:
- Assist leadership and team members with various project coordination and planning activities, including:
1. Maintaining resource and task activity sheets.
2. Scheduling and facilitating planning meetings.
3. Monitoring project assignments and timelines.
4. Identifying resource and priority conflicts.
5. Participating in workflow standardization and implementing efficiency projects.
6. Maintaining best practices and exploring project management tools.
Qualifications:
- Bachelor’s Degree in Engineering/Engineering Technology or Life Science discipline with 1-3 years of relevant experience, or a Master’s Degree with 0-2 years of experience.
- Demonstrated potential for technical proficiency, scientific creativity, and collaboration.
- Basic understanding of assay, bulk, and reagent manufacturing processes.
- Advanced technical writing skills for producing reports and documentation.
- Familiarity with 6 Sigma and Lean Manufacturing Methods during development phases.
- Proficiency in systems such as SAP and ETQ.
Compensation:
- Pay range: $27.00/hour - $32.00/hour.
- Benefits include Medical, Dental, Vision, and 401K (subject to minimum eligibility hours).
Diversity and Inclusion:
Roche is committed to fostering a diverse and inclusive environment, recognizing that diverse perspectives drive innovation and address business needs.