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Senior Vice President of CMC and Process Innovation
2 months ago
Position Title: Vice President of Biologics and CMC Development
Company: Stratacuity
Location: Cambridge, MA (Onsite)
Field: Biologics and Protein Therapeutics
Overview: We are in search of a proficient Vice President to spearhead the advancement, refinement, and technology transfer of bispecific protein therapeutics aimed at clinical trials. This position 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 protein manufacturing oversight and analytical study management, we encourage you to consider this opportunity.
Key Responsibilities:
- Direct internal process development, enhancement, and technology transfer initiatives
- Identify and oversee partnerships with CDMOs
- Facilitate IND preparation, including regulatory CMC documentation
Qualifications:
- Significant VP-level expertise in biologic CMC and process development
- Proven experience in selecting and managing CDMOs for technology transfer
- Familiarity with managing analytical studies related to IND submissions
- Willingness to travel to CDMO locations as necessary
About Stratacuity:
At Stratacuity, we are committed to fostering enduring relationships with biopharmaceutical professionals while ensuring confidentiality in all engagements. As an Equal Employment Opportunity/Affirmative Action Employer, we appreciate diversity and welcome candidates from all backgrounds. If you are prepared to assume a pivotal leadership role in the biologics sector, we invite you to explore this opportunity.
