Manufacturing Superintendent
Core
Supervise and lead a pharmaceutical manufacturing team in GMP production, purification, isolation, and packaging of synthetic chemical, natural extraction, and fermentation-related products.
Role type
Manufacturing Superintendent (IC)
Builds
Clinical-to-commercial scale active pharmaceutical ingredients (APIs) including microbial fermentation, synthetic small molecules, ADC, HPAPI, plasmid DNA, mRNA, and LNP.
Domain
Biopharmaceuticals / Contract Development and Manufacturing (CDMO)
Required skills
GMP compliance, batch record management, equipment troubleshooting, team leadership, regulatory inspection participation, process risk assessment, multi-discipline coordination
Preferred skills
Post-secondary degree in scientific field, GMP protocols and FDA guidance experience, leadership experience, technical experience in fermentation or synthetic chemistry
Technologies
Batch production records (BPRs), spreadsheets, word processing software
Responsibilities
Oversee team leads to accomplish departmental production needs; Review and verify completed batch production records (BPRs) including QCs, deviations, and cleaning sheets; Assist in updating BPRs to optimize process efficiencies; Identify, troubleshoot, and resolve equipment, process, and facility issues; Participate in hiring, training, and performance evaluation of employees; Interact with multi-discipline units to ensure product quality and on-time delivery.
Seniority
Mid-level, hands-on IC
