May be suitable for: Quality Control Manager
The successful candidate will be responsible for development, implementation and management of the QC Chemistry department for a cGMP biopharmaceutical manufacturing facility. Essential Duties and Responsibilities include, but are not limited to, the following:
Education and Experience:
- Lead and coordinate the startup of a new laboratory building including ensuring monitoring and communicating timeline.
- Ensure construction adherence to plan.
- Lead a team of six or more individuals to order equipment and supplies to facilitate occupation of the new QC Laboratory.
- Train on new analytical methods and ensure the successful transfer to the new laboratory.
- Oversee QC projects including analytical commitments for Regulatory filing, follow-up actions for general GMP inspections and its readiness.
- Track and coordinate major analytical investigation and method improvement.
- Track and monitor timeline of analytical validation projects.
- Monitor the departmental performance for NOE/EOE/DNF/CAPA/WF/OJT, track, assist and organize continuous improvement event.
- Coordinates with members of Manufacturing, R & D, and Formulation to provide analytical support.
- Interact with Regulatory Agencies as needed to ensure cGMP compliance.
- Supervises QC Analysts, distributes work load, and monitors progress.
- Special projects as assigned.
- BS in chemistry, biology or related field with 7+ years’ experience in laboratory management and analytical sciences and 5+ years’ experience in a supervisory/leadership capacity.
- Thorough understanding of Analytical Testing in a cGMP environment for Raw Materials, Wet Chemistry, and HPLC assays