Job Description
📋 Description SME for Small Molecules Drug Substance manufacturing Process owner for Small Molecules process validation Lead MSAT projects: manufacturing process optimization and cost improvement Participate in internal/external manufacturing activities (changes, CAPAs) Issue/review/approve internal and external SOPs and manufacturing instructions Oversee technical studies, qualifications, validations documentation 🎯 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 and regulatory file documentation Scientific/technical background in CMC development and manufacturing of drug substances (small molecules) Experience overseeing external vendors (CMOs/CDMOs) and cross-functional teamwork 🎁 Benefits Competitive 401(k) match Tuition and wellness reimbursements Comprehensive medical, dental, and vision package Additional recognition awards
