The manufacturing supervisor is responsible for coordinating effort within the Manufacturing Team to manufacture revolutionary clinical and commercial nucleic acid-based pharmaceuticals by interfacing with manual and automated production systems and controls in cGMP manufacturing environment while maintaining areas in a state of compliance with internal quality systems. Ensure personnel are trained and follow standard operating procedures to safely operate production equipment for manufacturing operations. Maintains records, processes, and clean room environments to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP). Identify, evaluate, test, and implement new technologies for process improvements. Responsible for the implementation of current Good Manufacturing Practices (cGMP) in production areas. Responsible for proficiency in assigned functional areas. Understands and applies biological, chemical, and mechanical principles and techniques.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Manufacture plasmid DNA conforming to GMP guidelines and VGXI SOPs.
Executes production plan by assigning personnel, accomplishing work results, establishing priorities, monitoring progress, and reporting results of the processing flow to Manufacturing Management.
Qualified in all processes involved in the manufacture of plasmid DNA and able to train and explain technical aspects of manufacturing processes to junior staff.
Specify and procure appropriate equipment as needed.
Install, commission and troubleshoot equipment as needed.
Interface with other operational departments to facilitate scale-up and technology transfer to meet growing demands.
Write and review Standard Operating Procedures (SOP) and production batch records.
Implement new equipment and processes for the manufacture of plasmid DNA.
Mentor junior staff and support team growth through the supervision of assigned projects.
Ensure continuous improvement initiatives and foster innovation within the Manufacturing staff.
EDUCATION and/or EXPERIENCE
Bachelor's Degree (B.S.) or equivalent; or three to five years related experience and/or training; or equivalent combination of education and experience.