Manager, Chemistry, Manufacturing, and Controls
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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.
Responsibilities:
- CMC Manager will play a key role in the development, licensure, and manufacturing of pharmaceutical products
- Manager will provide manufacturing oversite to ensure product meets and exceeds established criteria
- Manager will identify continuous improvement initiatives and will assist in resolving production and laboratory related investigations
- Manager 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 demand
- Manager will implement risk management practices for mitigating risks associated with product quality
- Manager will work with Regulatory to prepare and author CMC sections
Requirements:
- Candidates must have a Bachelors degree in a scientific discipline
- Candidates must have 5+ years pharmaceutical manufacturing experience with at least 2 years of CMC project management background in a leadership role
- Candidates must have a strong regulatory knowledge, preparing regulatory strategies and CMC related risk management assessments
- Candidates must have experience in process, product, and analytical development activities
- Candidates must have a solid technical knowledge of pharmaceutical manufacturing and packaging activities; experience in oral solid dose products preferred
