Head of Product Development
Job Description
Our client is seeking a strategic and experienced leader to oversee all aspects of Chemistry, Manufacturing, and Controls (CMC) from lead optimization through commercialization. This role will drive formulation, process development, clinical supply chain, and regulatory strategy—especially focused on Phase 3 and long-term extension studies.
Key Responsibilities:
- Lead internal teams and external CDMO partners across CMC functions
- Oversee manufacturing, analytical development, tech transfer, and clinical supply logistics
- Ensure regulatory readiness and author CMC sections for global filings (INDs, NDAs, IMPDs)
- Collaborate cross-functionally with Regulatory, Quality, and Clinical teams
- Manage department budgets and ensure operational excellence across the portfolio
Qualifications:
- PhD in pharmaceutical sciences, chemistry, or related field
- 15+ years of industry experience, including 10+ years in senior CMC leadership
- Deep expertise in injectable drug products and synthetic peptide manufacturing
- Strong understanding of global regulatory guidelines (ICH, FDA, EMA, USP)
- Proven success managing CDMO relationships and leading cross-functional teams
About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™
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