If you are driven by innovation, fueled by scientific curiosity, and committed to making a positive impact on the global pharmaceutical community, you've come to the right place. We are always looking for quality-minded, team-oriented individuals who share our dedication to excellence. At VGXI, we've cultivated a workplace that people genuinely enjoy being a part of, and we take immense pride in the role they play in shaping our success story. We embrace a culture of quality in our products and in our people. Explore the possibilities, unlock your potential, and contribute to the future of Plasmid DNA manufacturing and precision medicine with VGXI.
SUMMARY
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/downstream 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/Downstream Manufacturing. 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.
Upstream: Follow production records or SOPs and accurately document work to conduct cell banking, fermentation, and lysis processes for plasmid DNA manufacture.
or
Downstream: Follow production records or SOPs and accurately document work to conduct chromatography, filtration, aseptic processing, and product formulation and filling 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.
EDUCATION and/or EXPERIENCE
Bachelor's or Associate's degree or equivalent from college or technical school; or one to three years related experience and/or training; or equivalent combination of education and experience.