MSAT Technical Lead – Drug Substance (Sr Manager)

📋 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