Senior Vice President of CMC and Process Innovation

2 weeks ago


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

Job Title: Senior Vice President of CMC and Process Innovation

Company: Stratacuity: Proven Scientific Placement

Location: Cambridge, MA (Onsite)

Field: Biologics/Protein Therapeutics

Overview: We are in search of a dynamic and experienced Senior Vice President to spearhead the advancement, refinement, and technology transfer of bispecific protein therapeutics aimed at clinical development. This pivotal role encompasses the management of internal process innovation, collaborations with Contract Development and Manufacturing Organizations (CDMOs), and the preparation for Investigational New Drug (IND) submissions.

Key Responsibilities:

  • Direct and oversee internal process innovation, refinement, and technology transfer initiatives.
  • Identify and manage partnerships with CDMOs to ensure seamless tech transfer.
  • Facilitate IND preparation, including the development of regulatory CMC documentation.

Qualifications:

  • Proven track record in a VP-level role focusing on biologic CMC and process innovation.
  • Demonstrated experience in selecting and managing CDMOs for technology transfer projects.
  • Familiarity with overseeing analytical studies related to IND submissions.
  • Willingness to travel as necessary to engage with CDMOs.

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 celebrate diversity and encourage applicants from all backgrounds to consider this leadership opportunity in the biologics sector.



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