Director - Analytical Development

  • Mapp Biopharmaceutical, Inc.
  • Dec 05, 2018
Full time Professional Services

Job Description

Director Analytical Development

Job #18-19A

 

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.

Basic Qualifications:

  • BS Degree or equivalent in Biochemistry/Chemistry or related discipline
  • Minimum of 15 years' industry or related experience at a large Biopharmaceutical company
  • Experience with sterile and non-sterile monoclonal antibody/protein product analyses including HPLC (SEC, IEX, RP, CE), SDS-PAGE, peptide mapping, mass spectrometry, 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
  • 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

Preferred Qualifications:

  • Experience working with external CRO and CMO development and manufacturing partners is highly desired
  • Experience across all phases of biologic drug development
  • Experience working virtual and mentoring partner relationships
  • Bioanalytical and immunogenicity experience

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 in San Diego, California or may have the opportunity to work remotely. Travel (~30%) will be required for this position. 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/Affirmative Action/Disability/Vets 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.



For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.

https://www.applicantpro.com/j/942003-307440

URL

https://www.applicantpro.com/j/942003-307440