Senior Director of Biologics Process Development

4 days ago


Cambridge, Massachusetts, United States Stratacuity Full time

Job Overview: Lead and oversee the development, optimization, and tech transfer of bispecific protein therapeutics. Collaborate with internal teams and external Contract Development and Manufacturing Organizations (CDMOs) to prepare for Investigational New Drug (IND) submissions.

Key Responsibilities:

  • Develop and implement process development strategies for clinical development pipelines.
  • Select, manage, and oversee CDMO partnerships to ensure seamless tech transfer and manufacturing.
  • Prepare and oversee IND-enabling activities, including regulatory Chemistry, Manufacturing, and Controls (CMC) sections.
  • Lead clinical manufacturing efforts and ensure compliance with regulatory requirements.

Requirements:

  • Proven leader with extensive industry experience in biologic CMC and process development at a senior level.
  • Experience in selecting and overseeing CDMOs for tech transfer of protein manufacturing, including upstream and downstream methods.
  • Knowledge of analytical studies for IND submissions.
  • Ability to travel to CDMOs and collaborate with cross-functional teams.

About Stratacuity:

Stratacuity is a professional services firm that connects exceptional biopharmaceutical talent with industry leaders. Our team is dedicated to providing personalized career guidance and support to our clients. We value diversity, equity, and inclusion in the workplace and strive to create a welcoming environment for all employees.



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