Director, Process Chemistry
Fort Worth, Tarrant County, Texas, 76102, USA
Listed on 2026-10-09
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Pharmaceutical
Pharmaceutical Science/ Research, Pharmaceutical Manufacturing, Pharma Engineer, Regulatory Compliance Specialist
Director, Process Chemistry in API Development, responsible for managing API/Intermediate/RSM manufacturing at CMOs, including synthesis route development, process optimization, tech transfer, and process validation.
Objectives:support early-stage process identification, scale-up, and manufacturing strategy to enable clinical and commercial supply for serious diseases.
Responsibilities:oversee CMO operations, collaborate with R&D on lead optimization, manage tech transfer and process improvements, provide technical review of quality documentation, and lead process characterization efforts.
Qualifications:PhD in Organic Chemistry or Chemical Engineering with 5+ years of experience in API process development, including managing development teams and CMO operations in regulated environments.
Skills:expertise in NCE synthesis, physical organic chemistry, validation, quality systems, and regulatory filings; strong communication and leadership skills.
Preferred:10+ years of experience across full API development lifecycle, including marketed products.
High-Value:biopharma, API synthesis, process development, early to late-stage development, regulated environment, global regulatory compliance, remote work with occasional travel (~10%).
Collaboration:Collaboration with research, regulatory, and manufacturing teams; no specific therapeutic focus indicated.
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