Careers

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 commitment 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

 

 

 

Open Positions

Manager, Contract Manufacturing

Job Summary:

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.

Requirements:

  • Bachelor’s degree in Science or Engineering or equivalent.
  • At least 5 years of work experience 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.
  • Note:  This is a not senior level position and does not have any management duties at this time.

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 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.

Manager Drug Supply & Study Planning

Job Summary:

With experience in the pharmaceutical or biotech industry, the Manager, Drug Supply and Study Planning, has oversight of clinical supply chain logistics and study timeline planning for MEI’s drug development studies. The ideal candidate will have a background specific to pharmaceutical or biotechnology products, and the unique supply chain challenges present in a GMP environment.

Management Scope:  None at this time.

Responsibilities & Duties:

Clinical Supply

  • Support clinical study teams with study drug supply demand, forecasting, and logistical planning for all clinical trials
  • Manage vendors, including managing quotes, purchase orders, invoicing and forecasting and demand planning 
  • Support project total drug supply forecasting activities, including lot allocation activities
  • Work closely with CMC and Quality groups for production input into the supply chain, as well as to ensure release of product domestically and internationally
  • Provide expertise with packaging technologies
  • Provide input to the development of IP-related study documents including protocols, study and pharmacy manuals
  • Work with Quality Assurance to review and resolve all shipment issues (damage, temperature excursions, non-compliance).  Analyze root cause and design solutions to resolve recurring problems, including deviation and CAPA ownership.
  • Creatively seek out ways to improve supply chain processes.

Study Timeline Planning

  • Work closely with Clinical Operations and Project Management to plan and define clinical study deliverables, timelines, assumptions, and parameters
  • Track study timelines and generate status reports to ensure alignment with study plans and timelines and overall clinical development plan
  • Support scenario planning and evaluations.

Requirements:

  • A Bachelor’s degree in the sciences is preferred
  • Minimum of 5 years of planning experience in clinical supply chains in biotech/pharmaceutical industry
  • Minimum of 2 years of experience of clinical study timeline planning preferred
  • Global release and distribution logistics experience is required
  • Working knowledge of GMP and pharma industry procedures and regulations
  • Theoretical and practical knowledge of clinical supply forecasting and demand planning
  • Must possess import/export expertise including customs, transportation, and regulatory guidelines.
  • Ability to anticipate/define problems, collect and analyze data, make recommendations, and execute corrective actions and preventative measures
  • Strong interpersonal skills and the ability to work independently, as well as a member of a team
  • Must have exceptional verbal, written, presentation, communication and negotiation skills
  • Proficiency with: Microsoft Word/Excel/PowerPoint/Project software
  • Only San Diego candidates considered.

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 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.

     

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.

Recruiters, Agencies:

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.