MSAT Technical Lead – Drug Substance (Sr Manager)

📋 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.