We have recently partnered with one of our customers to provide direct hire recruiting services. By applying to this position, you assume you are not applying to a direct full-time role within CAI. During the screening process, details surrounding the client's location and benefits will be provided.
A Lead Upstream Process Technician is responsible for manufacturing 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. Follows standard operating procedures to operate production equipment for upstream operations. Maintains records, process and clean room environment to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP). Responsible for proficiency in assigned functional area: Upstream Manufacturing. Understands and applies biological, chemical and mechanical principles and techniques.
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 shift supervisor
Follow production records or SOPs and accurately document work to conduct cell banking, fermentation, and lysis processes for plasmid DNA manufacture.
Perform work following aseptic processing guidelines as appropriate.
Prepare solutions required for the production process (media and buffer make-up).
Clean, assemble, and sterilize equipment for production by operating glass washers and autoclaves.
Write or Revise Standard operating procedures
Install, commission and troubleshoot equipment as needed.
Responsible for documentation and maintenance of equipment, such as: documenting new equipment and equipment changes, conducting and documenting PM as required, ensuring proper documentation of equipment repair, etc.
Perform daily cleaning and sanitization of Production Areas.
Bachelor's or Associate's degree or equivalent from college or technical school; or three to five years related experience and/or training; or equivalent combination of education and experience
Excellent oral and written communication skills in English
Able to travel domestically and internationally if required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time or in the future