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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

Job Title: Vice President of CMC and Process Development

Company: Stratacuity

Location: Cambridge, MA (Onsite)

Field: Biologics/Protein Therapeutics

Overview: We are in search of a highly qualified 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, collaboration with Contract Development and Manufacturing Organizations (CDMOs), and the preparation for Investigational New Drug (IND) submissions.

Key Responsibilities:

  • Oversee internal process development, enhancement, and technology transfer initiatives
  • Identify and manage partnerships with CDMOs
  • Prepare regulatory CMC sections for IND submissions

Qualifications:

  • Significant VP-level experience in biologics CMC and process development
  • Proven track record in selecting and managing CDMOs for technology transfer
  • Experience in overseeing analytical studies related to IND submissions
  • Willingness to travel to CDMO facilities as required

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 consider this leadership opportunity in the biologics sector.