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

Quality Assurance Manager

Position Summary:

Reporting directly to the Associate Director of Quality Assurance, the Quality Assurance Manager is responsible for maintaining and execution of systems and processes to ensure compliance with cGMP regulations. The role is responsible for providing quality guidance and working with MEI internal departments to meet company goals and objectives.  Key functions are in the areas of Document Control, Records Management, Internal Audits, Training and Batch Review/Release. 

Responsibilities:

  • Tracks, monitors and processes MEI Change Requests in compliance with established procedures.
  • Manages cGMP records including records associated with: change history, vendor evaluation, audits, quality agreements, batch history, training, label approval, master copies and other records generated to comply with MEI quality requirements.
  • Works with internal departments to support the development of standard operating procedures, controlled forms, and product/labeling/packaging specifications for use in daily operations.
  • Manages the internal audit program including scheduling and performing internal audits.  Evaluates adequacy and effectiveness of corrective action plans.
  • Administers and evaluates the effectiveness of SOP Training.
  • Performs batch review and product dispositions.
  • Assists with preparation for regulatory inspections.  Provides documentation support during inspections.
  • Tracks, monitors and ensures compliance with key quality systems – Training, Complaints, Investigations, Exception reporting, Label approval and SOP review.
  • Performs or facilitates the performance of GXP Training.
  • Follows applicable regulations, including FDA, ICH, GXP, and MEI policies and procedures.
  • Other QA activities may be performed as required.

Requirements:

  • Bachelor’s degree in a scientific/technical discipline with 7+ years’ pharmaceutical experience, or an equivalent combination of education and experience with expertise in the following:  
  • Pertinent federal and state laws related to pharmaceutical industry.
  • Current FDA, EMA and federal regulations and guidance concerning the conduct of clinical research including Good Clinical Practice (GCP), desirable. 
  • Experience in Commercial Pharmaceutical QA systems a plus. 
  • Experience with Business, scientific and personal computer hardware and software applications (MS Word, Excel, Access, Outlook, Adobe Acrobat) as well as with Electronic Data Management Systems and their implementation, desirable.
  • High level of professionalism and collaboration in team settings. Ability to manage tasks with competing priorities or deadlines.
  • Successful experience in fast-paced entrepreneurial environment.
  • This is an office-based San Diego position with a potential for some travel as needed.

ADA Notations:

  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms.
  • Regular communication (hearing/speaking).
  • Ability to lift regular number of office supplies/files.
  • Routine office duties including computer keyboard use.
  • Vision requirements include: close vision and ability to focus.
  • Noise conditions range from quiet to moderate.

Clinical Research Associate or Senior Clinical Research Associate (In-House)

Job Summary:

The Clinical Research Associate (CRA) or Senior CRA (SCRA) role is to assist the Senior/Manager, Clinical Operations during the conduct of one or more clinical studies. The CRA/SCRA ensures that clinical study timelines and budgets are met, data quality is high, and the studies are conducted in compliance with current applicable laws and regulations, corporate policies, and ICH and GCP guidelines.

This position is based at MEI’s San Diego office with up to approximately 15% travel, as needed.

Responsibilities:

  • Assists the Senior/Manager Clinical Operations in overseeing clinical studies to ensure compliance with the study protocol, timeline and budget.
  • Coordinates investigational site startup activities, including the creation, preparation, and shipment of documentation (e.g., ICFs, CRFs, study manuals, study binders, etc.), Ethics Committee submissions and approvals, reviewing/approving Essential document packages, reviewing site changes to ICFs, facilitating completion of clinical study agreements and budgets, and shipment of clinical supplies.
  • Coordinates contract vendors and Clinical Research Organizations activities to ensure all are conducted according to study plans, timelines, budgets, and relevant SOPs.
  • Coordinates and maintains relevant tracking systems for subject screening, enrollment, study visits, data entry, query resolution.
  • Assists with the design of clinical studies.
  • Assists with protocol, case report form, source document template development, internal SOP/guideline development, final report preparation.
  • Reviews clinical databases on a real time basis to identify/resolve data entry issues, tracks the query process to identify/report evolving trends in the data.
  • Participates in project team meetings and conference calls to review progress of ongoing clinical trials.
  • May conduct co-monitoring visits to oversee CRO personnel and study conduct at the site.

Requirements:

  • Minimum 3 years’ experience as a CRA in the biotechnology or pharmaceutical industry; experience in hematology and/or oncology preferred.
  • Completed (or is in the process of completing) a CRA Certification Course preferred.
  • BS degree in a science or health-related science or equivalent preferred.
  • Proficient knowledge of GCP and ICH and medical terminology.
  • Ability to prioritize and multitask to ensure tasks are completed on or ahead of time
  • Strong interpersonal and written communication skills.
  • Excellent team, organizational, and planning skills.
  • Highly competent in Microsoft Office Suite including MS Word, Excel, PowerPoint.
  • Only San Diego area candidates will be considered; there is no relocation benefit.
  • Submit resumes to hr@meipharma.com.

    ADA Notations:

  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms
  • Regular communication (hearing/speaking)
  • Lifting of light-weight office supplies.
  • Routine office duties including computer keyboard use
  • 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.