Radius Health, Inc.

Director, Process Development

US-NJ-Parsippany
4 weeks ago
Job ID
2017-1650
# of Openings
1
Category
Pharmaceutical Sciences

Overview

Radius Health is seeking a Director, Process Development who will be responsible for developing manufacturing processes for API and DP for phase 3 through validation and commercialization, and for supporting technology transfer. The successful candidate will have membership in CMC and other project teams and collaborate closely with other CMC leaders including Commercial Manufacturing, Supply Chain, CMC Regulatory, and Analytical Science, as well as with other functions.

Responsibilities

  • Plans and oversees manufacturing process development, scale up, and technology transfer activities at third party manufacturers from development through validation and commercialization
  • Responsible for writing and/or reviewing relevant sections of IND/NDA’s and other regulatory filings.
  • Ensures alignment of process development and tech transfer activities with CMC and program development plans.

Qualifications

  • PhD in chemistry, chemical engineering or related discipline with at least 8 years of experience in the pharmaceutical industry
  • Expertise in process development for drug substance and drug product manufacturing
  • Late stage development, validation, NDA and transition to commercialization experience required
  • Expertise in technical transfer

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