Senior Manager, Drug Product Manufacturing

Job Summary

A company is looking for a Senior Manager, Manufacturing, Drug Product.

Key Responsibilities

• Develop, plan, and oversee drug product filling manufacturing programs, including material requirements, budgets, and timelines
• Manage and provide technical oversight to CDMOs for process technology transfer and cGMP manufacture of drug products
• Write and review relevant sections for regulatory submissions and oversee CPV implementation and data trending

Required Qualifications

• PhD/MS in relevant life sciences or engineering discipline with 5 years of experience, or BS with 8 years of experience in Pharmaceutical/Biotechnology
• Expertise in drug product filling operations and process validation
• Experience in CMC for biologics, including knowledge of process development and regulatory requirements
• Experience managing US/international CDMOs for cGMP drug product manufacture
• Working knowledge of FDA and international cGMP regulatory guidelines