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Manager, Chemistry, Manufacturing, and Controls

Accentuate Staffing

This is a Full-time position in Raleigh, NC posted September 30, 2021.

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

Job Requirements:

  • Manage manufacturing production processes and equipment
  • Providing plant input in manufacturing process development
  • Sustain process improvement initiatives utilizing lean manufacturing methodologies
  • Utilize and drive lean manufacturing principles throughout the global manufacturing sites and business partners
  • Release product and manufacturing areas for production
  • Eliminate waste in all manufacturing facilities
  • Develop manufacturing plan and establish procedures for maintaining high standards of manufacturing operations
  • Develop goals that support plant manufacturing objectives
  • Coordinate activities with other manufacturing personnel
  • Ensure best practices for manufacturing processes
  • Manage complex variety of manufacturing processes
  • Solving initiatives throughout the manufacturing organization
  • Driving the organization toward manufacturing excellence
  • Operate and efficiently run a manufacturing plant
  • Managing work load for manufacturing area
  • Direct the development of manufacturing processes and equipment
  • Provide manufacturing solutions to complex issues
  • Oversee multiple employees in a manufacturing environment
  • Improve manufacturing cycle time, and productivity while reducing waste, total errors, and manufacturing cost of the check manufacturing plants
  • Lead three distinct teams within the manufacturing facility