Sr. Director Drug Product Development and Manufacturing
Listed on 2026-09-14
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Pharmaceutical
Pharmaceutical Manufacturing, Regulatory Compliance Specialist, Pharmaceutical Science/ Research, Pharma Engineer
Role
Lead drug product development for small-molecule programs, focusing on formulation, manufacturing process development, and regulatory compliance.
Responsibilitiesestablish scalable formulations, oversee technical activities at CMOs—including tech transfer, process validation, and clinical supply—coordinate with Quality and Analytical teams, author regulatory submissions (INDs, NDA/MAA), and manage internal teams.
QualificationsPh.D. in Chemistry, Pharmaceutical Sciences, or related field with 10+ years of late-phase drug product experience, particularly in GMP oral solid dose manufacturing, formulation development, and CMO management.
Extensive knowledge of cGMP, ICH, FDA, EMA, and global packaging regulations is essential.
Preferredstrong leadership skills, cross-functional collaboration, excellent communication, and the ability to manage complex projects in a fast-paced environment.
High-valuefocus on small-molecule formulations, late-phase development, regulatory filings, and global manufacturing compliance.
Work setupnot specified; travel up to 25% domestically and internationally.
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