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Executive Director of Biologics and Process Development

2 months ago

Cambridge, Massachusetts, United States Stratacuity Full time
Job Overview

Stratacuity is seeking a seasoned leader to oversee the development, optimization, and tech transfer of bispecific protein therapeutics. The ideal candidate will lead clinical manufacturing efforts between internal teams and external Contract Development and Manufacturing Organizations (CDMOs) for clinical development preparing for Investigational New Drug (IND) submissions.

Key Responsibilities
  • Lead internal process development, optimization, and tech transfer of upstream and downstream process development for clinical development pipeline
  • Select, manage, and oversee CDMO partnerships
  • Tech transfer of methods and processes to CDMO for early-stage clinical manufacturing
  • Prepare and oversee IND-enabling activities, including regulatory Chemistry, Manufacturing, and Controls (CMC) sections
Requirements
  • Seasoned leader with extensive industry experience in biologic CMC and process development at the executive level
  • Extensive experience selecting and overseeing CDMOs for tech transfer of protein manufacturing, including both upstream and downstream methods
  • Exposure to managing analytical studies for IND submissions
  • Ability to travel to CDMOs
About Stratacuity

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. We are committed to providing a fair and inclusive hiring process.