MSAT Technical Lead – Drug Substance (Sr Manager)

📋 Description

• SME for Small Molecules Drug Substance Manufacturing.
• Process owner of Small Molecules process validation.
• Lead MSAT projects for manufacturing process and cost improvements.
• Participate in internal/external manufacturing changes, deviations, CAPAs.
• Manage SOPs and manufacturing instructions; review/approve.
• 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 for clinical and commercial use.
• 3+ years in a commercial setting leading product transfer, scale-up, and validation.
• Experience reviewing APR/PQR sections.
• Scientific/technical background in CMC development and manufacturing of drug substances, small molecules.
• Experience with regulatory guidelines, authorities' communication, and file documentation.

🎁 Benefits

• Competitive 401(k) match
• Tuition and wellness reimbursements
• Comprehensive medical, dental, and vision package
• Additional recognition awards