Responsible for the implementation of cGMP in the pilot plant. Write and review SOPs and
production batch records. Implement production processes for the manufacture of plasmid
DNA. Conduct cGMP production of plasmid products on an ongoing basis.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Manufacture plasmid DNA conforming to GMP guidelines
Assist in scaling-up processes to meet growing demands
Write Standard Operating Procedures
Execute validation protocols
Prepare solutions and materials required for the process
Follow batch records or SOPs to conduct cell banking, fermentation and purification
processes for plasmid DNA manufacture at research or GLP scale.
Conduct miniprep, concentration and gel analysis to in-process samples of research and
Install, commission and troubleshoot equipment as needed.
Responsible for documentation and maintenance of equipment, such as: documenting
new equipment and equipment changes, changing temperature charts, conducting and
documenting PM for certain equipment, etc.
Candidates must have a life sciences Bachelor’s or Associate’s degree or high school
diploma with 3 years of relevant experience.
Experience with plasmid purification and microbiology techniques is preferred.
Bioprocessing and GMP experience is a plus.
Contract to hire position
VGXI is an Equal Opportunity Employer.