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Senior Manager, Contract Manufacturing

Employer
MEI Pharma, Inc.
Location
San Diego, CA
Start date
Sep 30, 2022

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Job Summary:

MEI Pharma is a clinical-stage pharmaceutical company committed to the development and commercialization of novel, best-in-class, cancer therapies intended to improve outcomes for patients. Our approach is to fully understand and leverage the mechanisms and properties of our drug candidates to optimize the balance between efficacy and tolerability to best meet the needs of patients with cancer.

The Sr. Manager, Contract Manufacturing will report to the Sr. Director, Technical & CMC Operations and will work closely as a subject matter expert with other 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 development programs.

Role & Responsibilities:

  • The ideal candidate will be an experienced pharma/biotech contributor with a strong scientific background and expertise in the management of cGMP Manufacturing of small molecule drug substance (API), oral dosage form and parenteral drug products using global Contract Manufacturing Organizations (CMOs)
  • Provide support to on-going CMC projects working closely with other subject matter experts on the project team(s)
  • Work closely with MEI Supply Chain in planning manufacturing campaigns. Provide person-in-plant coverage, as needed
  • Apply project management expertise across MEI’s CMC programs for standard and complex projects while managing multiple activities in parallel
  • Assist team leader(s) to organize and schedule meetings
  • Report on project progress, offer viable solutions and opportunities as they arise
  • Implement appropriate project change controls in accordance with MEI SOP’s
  • Facilitate all assigned project team meetings and interactions; attend related cross-functional project team meetings as necessary to ensure alignment
  • Facilitate cross-functional team meetings and interactions with Technical Operations, Pharmaceutical Sciences, Clinical, Quality and Regulatory departments as well as CMO’s
  • Develop and communicate project status to internal stakeholders (e.g., Functional Leadership, Program Leadership, MEI Sr. Leadership)
  • Manage shipments of bulk raw materials, reference standards, API and drug product between contract manufacturers, as necessary
  • Support tracking contract financials, milestones, deliverables and monthly accruals
  • 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

Qualifications:

  • Excellent written and verbal communication, organizational and prioritization skills
  • Detail-oriented while also retaining the ability to see the big picture
  • Strong interpersonal skills and business acumen, excellence in building and managing relationships, ability to understand all perspectives, find common ground and effectively bridge significant differences

Job Requirements and Education

  • Bachelor’s degree in the Chemical/Biological Sciences or Engineering or equivalent, advanced degree preferred
  • At least 5 years of work experience in a cGMP manufacturing environment
  • Familiarity with relevant US/EU regulatory and quality requirements, standards, and practices
  • Familiarity with document management platforms, e.g. Veeva, Master Control
  • Familiarity with Lean Six Sigma and project management principles and practices is a plus
  • Project management qualification achieved or planned to achieve (i.e., Project Management Professional (PMP) or equivalent) is a plus
  • Experience with shipping logistics is a plus
  • Proficiency with Microsoft Office suite (e.g., Word, Excel, PowerPoint, Outlook, Sharepoint) and project timeline management tools (e.g., SmartSheet, Microsoft Project) is a plus

ADA Notations:

  • 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
  • Vision requirements include close vision and ability to focus
  • Noise conditions range from quiet to moderate

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