Manager of CMC Operations

Job Overview We are seeking an experienced Manager, CMC Operations to oversee drug manufacturing, packaging, labeling, stability testing, and clinical trial supply. This role will manage external manufacturing partners, vendors, and global logistics to ensure clinical trials receive the supplies they need on time.

Key Responsibilities

Manage external manufacturing partners responsible for drug production and GMP manufacturing. Oversee stability testing, review results, and support product shelf-life assessments. Manage clinical packaging, labeling, and expiration date updates. Forecast clinical supply needs and manage inventory and resupply plans for clinical sites. Coordinate clinical supply systems, including setup, testing, inventory tracking, and resupply. Oversee temperature-controlled shipping and investigate temperature excursions that may affect product quality. Work with clinical research partners and trial sites to ensure proper drug preparation and administration. Coordinate batch certification and required documentation with qualified personnel. Review manufacturing records, protocols, reports, deviations, and change controls. Manage international shipping, customs, and import/export requirements. Support regulatory submissions and related CMC documentation.

Required Qualifications

Master’s degree in Pharmaceutical Sciences, Chemistry, or a related field; PhD preferred. At least 5 years of experience in the pharmaceutical or biotechnology industry. Experience managing external manufacturing partners or vendors. Knowledge of GMP, GDP, cold-chain logistics, and clinical supply requirements. Strong project management, communication, and collaboration skills.