Associate Director, Drug Product Cell Potency Assay Development

Employer
Moderna
Location
Massachusetts
Salary
Competitive
Posted
April 27 2017
Organization Type
Biotech
Associate Director, Drug Product Cell Potency Assay Development

Position Summary

Moderna is seeking a highly skilled, meticulous and motivated leader for a position based at their Cambridge, MA site.  The individual will play a central role in guiding the team responsible for establishing, qualifying and performing cellular assays to support the analysis and release of Moderna's mRNA drug products.

Responsibilities

  • Lead a team of research associates in the development, qualification and performance of in vitro assays (ELISA, FACS, reporter systems, Western blotting, functional activity) using cultured, primary and other mammalian cells
  • Identify contract research organizations and transfer cell-based assays for qualification, validation, product release and stability testing under GMP conditions
  • Coordinate interactions, activities and data analysis with contract research organizations
  • Provide results analysis and preparation of documents/reports for regulatory filings
  • Closely collaborate with members within the Technical Development team, and broadly with the R&D departments throughout the company to develop bioassays
  • Accountable for project success, results delivery and progress relative to timelines
  • Record and communicate findings
  • Present results at internal meetings

Qualifications

  • Ph.D. with at least 7 years of industry experience, or MS with at least 10 years of industry experience (Cell Biology, Biochemistry, Molecular Biology, or related science), developing, qualifying and performing cell-based potency assays for drug product release
  • Hands on experience with mammalian cell culture and the utilization of cell-based assays to evaluate the expression and activity of a variety of protein targets
  • Extensive knowledge of ELISA and FACS assay method development
  • Understanding of the regulatory landscape and government agency guidance for bioassay development, qualification and validation
  • Familiarity with nucleic acid therapeutic characterization
  • Excellent interpersonal and collaborative skills, and the ability to work independently and effectively in a highly dynamic environment
  • Ability to multi-task to meet aggressive timelines and technology development goals

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Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.