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.
- Supervise manufacturing personnel through task assignment, delegation, and follow-up in production of 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 cGMP productions.
- Install, commission and troubleshoot equipment as needed.
- Responsible for documentation and maintenance of equipment, including 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 with 3 or more years of GMP manufacturing experience.
- Experience with plasmid purification and microbiology techniques is preferred. Bioprocessing is a plus.
Interested candidates email email@example.com.