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: 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