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Manager, Chemistry, Manufacturing, and Controls

Company: Accentuate Staffing
Location: Durham
Posted on: October 13, 2021

Job Description:

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

  1. CMC Manager will play a key role in the development, licensure, and manufacturing of pharmaceutical products
  2. Manager will provide manufacturing oversite to ensure product meets and exceeds established criteria
  3. Manager will identify continuous improvement initiatives and will assist in resolving production and laboratory related investigations
  4. Manager will monitor supplier performance and identify opportunities to streamline activities, minimize waste, increase efficiencies, etc.
  5. Manager will ensure that commercial production and supply remains aligned with forecast demand
  6. Manager will implement risk management practices for mitigating risks associated with product quality
  7. Manager will work with Regulatory to prepare and author CMC sections

Requirements

  1. Candidates must have a Bachelors degree in a scientific discipline
  2. Candidates must have 5+ years pharmaceutical manufacturing experience with at least 2 years of CMC project management background in a leadership role
  3. Candidates must have a strong regulatory knowledge, preparing regulatory strategies and CMC related risk management assessments
  4. Candidates must have experience in process, product, and analytical development activities
  5. Candidates must have a solid technical knowledge of pharmaceutical manufacturing and packaging activities; experience in oral solid dose products preferred

Keywords: Accentuate Staffing, Durham , Manager, Chemistry, Manufacturing, and Controls, Other , Durham, North Carolina

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