Manager, Chemistry, Manufacturing, and Controls

Accentuate Staffing is assisting a growing pharmaceutical company in the Raleigh area who is looking for a Manager, Chemistry, Manufacturing, and Controls to join their team. This is a direct hire opportunity working 8:30am-5pm Monday-Friday.ResponsibilitiesCMC Manager will play a key role in the development, licensure, and manufacturing of pharmaceutical productsManager will provide manufacturing oversite to ensure product meets and exceeds established criteriaManager will identify continuous improvement initiatives and will assist in resolving production and laboratory related investigationsManager will monitor supplier performance and identify opportunities to streamline activities, minimize waste, increase efficiencies, etc.Manager will ensure that commercial production and supply remains aligned with forecast demandManager will implement risk management practices for mitigating risks associated with product qualityManager will work with Regulatory to prepare and author CMC sectionsRequirementsCandidates must have a Bachelors degree in a scientific disciplineCandidates must have 5+ years pharmaceutical manufacturing experience with at least 2 years of CMC project management background in a leadership roleCandidates must have a strong regulatory knowledge, preparing regulatory strategies and CMC related risk management assessmentsCandidates must have experience in process, product, and analytical development activitiesCandidates must have a solid technical knowledge of pharmaceutical manufacturing and packaging activities; experience in oral solid dose products preferred

Created: 2021-11-29