Summary: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:
• 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.


Education and Experience:
• 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