Supervisor, Operations Project Lead #0042340
Supervisor, Operations Project Lead - Catalent Pharma Solutions (San Diego, CA)- Must have proof of legal authorization to work in U.S.
JOB DESCRIPTION:
Responsible for project coordination and the GMP manufacturing operations for Phase I and Phase II clinical trial productions. Supervise direct reports, including managerial responsibilities including the allocation of resources, organization of projects and performance reviews Provide leadership and functional job training for Manufacturing Coordinators (all levels), including development and staff recognition. Oversee client contacts for all projects maintained by direct reports, including the handling of issues or sensitive subjects that arise. Collaborate with Pharmaceutics personnel and client with co-managing cGMP runs Facilitate MFG tech transfer meetings with Process Development Host clients on-site / lead client meetings/conference calls Participate in group meetings, inter- and intra-department meetings, conference calls and interactions with clients with minimal assistance from the department head. Review manufacturing batch records for the following types of cGMP productions: manual and automated encapsulation, tableting, coating, fluid bed granulation, roller compaction, liquid fill/banding, spray dry dispersions, and more. Provide troubleshooting support in MFG suites Provide supervisor level signoff of variances prepared by Manufacturing Coordinators (all levels), and collaborate with QA and Operations Management on root cause and CAPA plans. Perform root cause analysis, address production issues and generate production variances and address product related-complaints, when applicable. Support Business Development by providing technical expertise, support regarding timelines.
EDUCATION AND EXPERIENCE REQUIREMENT: Requires a Master’s degree in Chemical Engineering, Chemistry, Biochemistry or a related field and 3 years of experience in the job offered or 3 years of experience in the Related Occupation.
RELATED OCCUPATION:
Quality Assurance Manager or any other job title performing the following job duties:
- Responsible for project coordination and the GMP manufacturing operations for nutraceutical productions.
- Write manufacturing batch records for the following types of cGMP productions: manual and automated encapsulation, tableting, coating, and more.
- Review cGMP runs with Development personnel and client.
- Serve as primary contact for clients on production issues. Participate in discussions with client on project related production topics.
- Prepare product label specification and generate product labels for productions.
- Perform root cause analysis, address production issues and generate production variances.
- Generate Corrective Actions and Preventive Actions (CAPAs) to prevent re-occurring deviations.
- Provide batch record training to production technicians on complex processes.
- Propose solutions to supervisor for production problems.
- Revise SOPs/streamline production batch records.
- Work with a cross-functional team to ensure successful process transfer from development into cGMP manufacturing.
- Understand the work flow in the production suites.
- Provide troubleshooting support in MFG suites.
- Review executed batch records.
- Address product related-complaints.
- Host clients on-site/in client meetings.