Job Description
📋 Description SME for Small Molecules Drug Substance Manufacturing. Process owner of Small Molecules process validation. Lead MSAT projects for manufacturing process and cost improvements. Participate in internal/external manufacturing changes, deviations, CAPAs. Manage SOPs and manufacturing instructions; review/approve. Oversee technical studies, qualifications, and validations. 🎯 Requirements University degree in Chemistry, Biology, Biotechnology, Pharmacy, or similar. 6+ years in development and manufacturing of small-molecule drug substances for clinical and commercial use. 3+ years in a commercial setting leading product transfer, scale-up, and validation. Experience reviewing APR/PQR sections. Scientific/technical background in CMC development and manufacturing of drug substances, small molecules. Experience with regulatory guidelines, authorities' communication, and file documentation. 🎁 Benefits Competitive 401(k) match Tuition and wellness reimbursements Comprehensive medical, dental, and vision package Additional recognition awards
