Director Bioassay

Mapp Biopharmaceutical
Published
October 11, 2018
Location
San Diego, CA
Category
Default  
Job Type

Description

Director Bioassay

Job #18-16A

 

Mapp Biopharmaceutical, Inc. "Mapp" is a 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. The development, qualification/validation and implementation of bioassays to quantify drug potency and other key functional attributes are critical to biologic drug development and manufacture. The Director Bioassay contributes and/or assists in leading the efforts of the Bioassay group. Travel (<10%) is required for this position.

Basic Qualifications:

  • Advanced Degree or equivalent required in Cell Biology or a related discipline
  • 10 years' industry or related experience with 5+ years' in cGMP CMC method advancement
  • 3 years' experience of technical project management of bioassay development performed in contract research settings either within the CRO or as the contracting lead scientist
  • Proven ability to manage bioassay development, optimization and qualification within a CRO or with CRO partners
  • Solid knowledge of cGMP practices for analytical laboratories and familiarity with ICH and FDA guidance, as well as USP-suggested practices, regarding bioassay advancement and management
  • Ability to effectively manage multiple projects to meet timeline, technical and quality requirements
  • Knowledge of data analysis software for (including but not limited to)
    • Linear regression analysis
    • Non-linear regression analysis
    • Parallelism analysis
  • Knowledge of data acquisition modalities commonly employed in bioassays and experience in using appropriate instrumentation including:
    • Plate luminometers
    • Plate fluorimeters
    • Spectrophotometers
    • Multi-mode plate readers

Preferred Qualifications:

  • Ph.D. in Cell Biology or related discipline
  • Experience across all phases of biologic drug development
  • Experience working in teams with diverse cultural and professional backgrounds
  • Experience working in virtual partner relationships

Responsibilities

  • Manages external contractor sites at all stages and in regards to all technical aspects and assists quality assurance/regulatory functions for bioassay activities
  • Coordinates and facilitates advancement of internal objectives including RFPs, proposals, reports and regulatory documents
  • Manages the generation, qualification and distribution of key reagents
  • Providing technical and logistic support to the Mapp Analytical Department
  • Guides technical development and troubleshooting of bioassays at CRO and CMO partners through email communication, teleconferences and on-site visits
  • Performs review and, when necessary, additional analyses, of data generated by vendor laboratories
  • Authors internal reports
  • Interfaces with PMs and Grants/Contract personnel to:
    • Identify and evaluate potential vendors for:
      • Assay development, optimization, qualification and validation
      • Manufacture and storage of key reagents
    • Generate technical sections of RFPs,SOWs
    • Evaluate proposals pertaining to bioassay development and reagent production
  • Interfaces with Quality Assurance to:
    • Review and facilitate closure of technical noncompliance bioassay related issues at CRO and CMO partners
  • Assures key reagent manufacture adheres to appropriate compliance procedures as they relate to the stage of development
  • Contributes to Mapp Analytical CMC documents for registration purposes, including IMPDs, IND, MAA, BLA and responses to agency questions and assist CMC project teams in strategic planning, preparation, review and approval of submission documentation
  • Interfaces with ERDG to identify:
    • Potential assays for development
    • Construct/expression strategies for key recombinant protein reagents
    • Collating, summarizing and organization of early phase method information for future advanced development use

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. This job will have the opportunity 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.

Mapp is an 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/907092-316875

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