Contract Manufacturing Manager
MEI Pharma is a San Diego-based oncology company focused on the clinical development of novel therapies for cancer. Our portfolio of drug candidates includes Pracinostat, an oral HDAC inhibitor that is being developed in combination with azacitidine for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Our clinical development pipeline also includes ME-401, a highly selective, oral PI3K delta inhibitor, voruciclib, an oral, selective CDK inhibitor, and ME-344, a novel mitochondrial inhibitor. MEI currently has an open position for a Contract Manufacturing Manager:
The Contract Manufacturing Manager reports to the Director of CMC & Product Development and works with MEI’s subject matter experts and contract manufacturers to provide operational support and oversight for drug substance and drug product manufacturing activities across MEI’s programs.
Management Scope: None at this time
Responsibilities and Duties:
- Manage shipments of bulk raw materials, reference standards, API and drug product between contract manufacturers.
- Track reference standards expiration and re-qualification
- Coordinate drug product packaging and labelling operations
- Track contract financials, milestones and deliverables
- Verify and record invoices
- Perform monthly review to ensure all manufacturing contracts are appropriately recorded
- Facilitate MEI approval of manufacturer documents in compliance with MEI’s Change Management SOP
- Capture and organize electronic manufacturing records in accordance with MEI’s Records Management SOP.
- Bachelor’s degree in Science or Engineering or equivalent
- 5+ years of work experience working in a cGMP-regulated environment
- Familiarity with relevant US/EU regulatory and quality requirements, standards, and practices
- Experience with shipping logistics a plus
- Proficient in Microsoft Office (Excel, Word), and generally facile with electronic information technologies. Familiarity with Excel data transformation and manipulations using formulas, graphs and pivot tables is also a plus.
- Only San Diego candidates considered.
- Ability to sit for long periods of time, handling, feeling with hands, reaching with arms.
- Regular communication (hearing/speaking).
- Routine office duties including computer keyboard use and some lifting of light-weight office equipment and files as needed.
- Vision requirements include: close vision and ability to focus.
- Noise conditions range from quiet to moderate.
Please submit your resume.