Job Description
📋 Description Subject matter expert for Small Molecules Drug Substance Manufacturing. Process owner for Small Molecules process validation for Sobi products. Lead MSAT projects including manufacturing process and cost improvements. Participate in internal/external manufacturing activities: deviations, risk assessments, CAPAs. Review and approve internal and external SOPs and manufacturing instructions. 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. 3+ years in a commercial setting leading product transfer, scale-up, and validation. Experience reviewing APR/PQR sections. Scientific/technical background in CMC development for small-molecule drug substances. Experience overseeing external vendors such as CMOs, CDMOs. 🎁 Benefits Competitive total rewards package. Comprehensive medical, dental, and vision benefits. Generous time off policy. Tuition and wellness reimbursements. Opportunities to attend conferences and events. Collaborative and team-oriented environment.
