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

Director Analytical Development

Job #06-17A

 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 diseases, such as neglected and tropical infectious diseases. The Director of Analytical Development will act as primary liaison with partner and contractor sites and guide external Analytical and Quality Control operations for Drug Substance and Drug Product development and manufacturing.

 Requirements

  • Minimum of a BS Degree in Biochemistry/Chemistry or related discipline
  • Minimum of 15 years' industry or related experience at a large Biopharmaceutical company
  • High-level experience in Bioassay development, qualification, and validation activities of Biopharmaceuticals
  • Experience with sterile and non-sterile product analyses including HPLC (SEC, IEX, RP, CE), SDS-PAGE, peptide mapping, enzyme kinetics, bioassay, dissolution and other compendial methods
  • Experience in leading analytical method development, validation and transfer activities as well as extended characterization assays with a good understanding of cGMP and FDA regulations and guidelines in CMC related areas are required
  • Experience working with external CRO and CMO development and manufacturing partners is highly desired
  • Experience across all phases of biologic drug development
  • Experience in working in teams with diverse cultural and professional backgrounds
  • Experience working virtual and mentoring partner relationships
  • Solid knowledge of cGMP practices for analytical laboratories and familiar with ICH and FDA guidance
  • Excellent interpersonal and communication skills
  • Effective problem solving skills and results orientated
  • Ability to effectively manage multiple projects to meet timeline, technical and quality requirements

 Responsibilities

  • Guides technical development and troubleshooting of analytical methods at CRO and CMO partners
  • Designs and executes extended characterization studies for biologic products and process impurities
  • Reviews SOPs, protocols, analytical validation reports, stability reports and other technical reports to support regulatory submissions
  • Serves as the subject matter expert in analytical chemistry and support or lead the analytical group on CMC teams
  • Plans, directs and authors CMC documents for registration purposes, including IMPDs, MAA, BLA and responses to agency questions and assist CMC project teams in strategic planning, preparation, review and approval of submission documentation
  • May have limited supervisory duties
  • Other duties as assigned

 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 where you can work remotely. Travel will be required. Mapp wants you to join their team and invites you to apply by submitting your resume on Mapp's website - https://mappbio.applicantpro.com/jobs/.

No Solicitors, agents or placement agencies please. 

 Equal Opportunity Employer - Applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

 

Mapp Biopharmaceutical
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