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Head of Product Development

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 functionsOversee manufacturing, analytical development, tech transfer, and clinical supply logisticsEnsure regulatory readiness and author CMC sections for global filings (INDs, NDAs, IMPDs)Collaborate cross-functionally with Regulatory, Quality, and Clinical teamsManage department budgets and ensure operational excellence across the portfolioQualifications:PhD in pharmaceutical sciences, chemistry, or related field15+ years of industry experience, including 10+ years in senior CMC leadershipDeep expertise in injectable drug products and synthetic peptide manufacturingStrong understanding of global regulatory guidelines (ICH, FDA, EMA, USP)Proven success managing CDMO relationships and leading cross-functional teamsAbout 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™ Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

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