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Senior Vice President of CMC and Process Engineering

2 months ago

Cambridge, Massachusetts, United States Stratacuity: Proven Scientific Placement Full time

Position Title: Vice President of Biologics and Protein Therapeutics

Company: Stratacuity

Location: Cambridge, MA (Onsite)

Field: Biologics and Protein Therapeutics

Overview: We are in search of an accomplished Vice President to spearhead the development, refinement, and technology transfer of bispecific protein therapeutics aimed at clinical advancement. This pivotal role encompasses the management of internal process development, collaborations with Contract Development and Manufacturing Organizations (CDMOs), and preparation for Investigational New Drug (IND) submissions to facilitate clinical manufacturing. If you possess substantial leadership experience in biologic CMC and process development, particularly in overseeing protein manufacturing and directing analytical studies, we invite you to consider this opportunity.

Key Responsibilities:

  • Direct internal process development, enhancement, and technology transfer initiatives
  • Identify and oversee partnerships with CDMOs
  • Prepare comprehensive documentation for IND submissions, including regulatory CMC components

Qualifications:

  • Significant VP-level expertise in biologic CMC and process development
  • Proven experience in selecting and managing CDMOs for technology transfer
  • Familiarity with overseeing analytical studies related to IND submissions
  • Willingness to travel to CDMO facilities as necessary

About Stratacuity:

At Stratacuity, we are committed to fostering enduring relationships with biopharmaceutical professionals while ensuring confidentiality in all interactions. As an Equal Employment Opportunity/Affirmative Action Employer, we embrace diversity and encourage applicants from all backgrounds to explore opportunities within our organization. If you are prepared to assume a leadership position in the biologics sector, we look forward to connecting with you.