Job Description
📋 Description SME for Small Molecules Drug Substance Manufacturing Process owner for Small Molecules process validation Lead MSAT projects: process improvements and cost reduction (LCM) Participate in internal/external manufacturing activities: process changes, deviations, risk assessments, CAPAs Issue/review/approve SOPs and manufacturing instructions Lead product transfer, scale-up, validations; oversee external SM manufacturing for clinical/commercial 🎯 Requirements University degree in Chemistry, Biology, Biotechnology, Pharmacy or similar 6+ years in development and manufacturing of small-molecule drug substances for clinical/commercial use 3+ years in commercial settings, leading product transfer, scale-up, and validation Experience reviewing APR/PQR sections Scientific/technical background in CMC development and manufacturing of drug substances Experience with regulatory guidelines, authorities' communication, and file documentation Experience overseeing external vendors such as CMOs/CDMOs Cross-functional teamwork; multitask, prioritize, and decisive 🎁 Benefits Competitive total rewards package Competitive 401(k) match Tuition and wellness reimbursements Comprehensive medical, dental, and vision coverage Additional recognition awards
