MEI Pharma's staff is a team of friendly, dedicated, experienced and collaborative professionals committed to the hard work that supports our company's aggressive goals and to the workplace values that promote our success.
Our workplace values include:
- Shared commitement to excellence and collaboration across functions
- Personal accountability for consistent superior performance
- Fiscal discipline applied wisely in the use of resources
- Mutual trust and respect for individual differences
- Dedication to developing novel therapies for our patients
Contract Manufacturing Manager
The Contract Manufacturing Manager reports to the Director of CMC & Products 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 / 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.
Equal Opportunity Employer:
MEI Pharma, Inc.'s policy is to provide equal opportunities to all employees and employment applicants without regard to unlawful considerations of race, color, national ancestry, sex, gender, age, religion, physical or mental disability, medical condition, genetic information, pregnancy, marital status, sexual orientation, gender identity, gender expression, military or veteran status or any other classification protected by applicable local, state or federal laws.
The recruitment and employment process at MEI Pharma, Inc. is managed exclusively through the Human Resources Department with all candidates applying directly in this manner. The company does not accept unsolicited resumes from any source other than from qualified candidates and only for current open positions.