Mapp Biopharmaceutical
  • San Diego, CA, USA
  • Full Time

Director, Quality Assurance

Parental Drug Product Manufacturing

Job #09-17A

 

Mapp Biopharmaceutical is a small biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases.  Under limited supervision functions as a key member of the Quality Assurance team. Partners with the Quality Assurance and program team to deliver the Mapp portfolio. Provides leadership for all Quality Assurance related activities at the parenteral Drug Product manufacturing sites.

Basic Qualifications:

  • BS Degree in Science
  • 10+ Years of Product Development and or commercial manufacturing experience in a regulated pharmaceutical industry; preferably in a mid-to-large sized biopharmaceutical company
  • Up to 10+ Years of experience in a QA-GxP role or a role that interacts with Quality Assurance
  • Direct experience in providing oversight (either technical or QA) for parenteral Drug Product manufacture
  • Knowledge of drug development regulations such as the GCPs, GMPs and GLPs
  • Must have previous technical or QA experience in the oversight or execution of cGMP parenteral manufacturing operations
  • Previous experience with large molecule, protein-based parenteral
  • Previous experience with auditing
  • Travel required (up to 25% domestic and international)

Preferred Qualifications:

  • Experience across all phases of biologic drug development (Clinical phases 1 thru 4 of drug development)
  • Ability to effectively manage multiple projects to meet timeline, technical and quality requirements
  • Understands patient dosing on a mg/kg basis
  • Previous experience with monoclonal antibody parenteral manufacturing
  • Experience in a technical or QA role for the oversight or execution of monoclonal antibody Drug Substance manufacture is an asset
  • Previous experience supporting Pre-approval Inspections is desirable
  • Experience working virtual

Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will enjoy a flexible, collaborative and rewarding environment in San Diego, CA or may have the opportunitiy to work remotely. Mapp wants you to join their team and invites you to apply.

No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify. 

Equal Opportunity Employer - Applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.

Mapp Biopharmaceutical
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