BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Lead Production Associate to work for a leading San Diego biotechnology company.
Lead Production Associate
The successful candidate will primarily be responsible for cell culture, dilution cloning, and analysis of stable cell clones. Addition responsibilities will include implementing production and manufacturing procedures, assisting with process improvement projects and ensuring regulatory requirements. This associate may be responsible for performing various aseptic procedures in a cGMP clean room environment both inside and outside of a biosafety cabinet depending on the level of experience. Familiarity with biopharmaceutical production processes from cell thaw, cell culture, bioreactors and harvest of unprocessed bulk is expected. Writing development reports, protocols and batch records as well as participation in technology transfer will be required. Experience with downstream/purification processes is a plus. This associate will demonstrate strong scientific/technical and interpersonal skills as well as the ability to communicate effectively. This associate will be self motivated and able to work independently.
B.S. in biology/life sciences or related field with 5+ yrs industrial experience in process development and cGMP manufacturing
Expertise in cell culture, purification experience a plus
Proficiency in manufacturing of products following SOPs, batch records and demonstrated experience working within a cGMP regulated environment required
Ability to observe technical issues and assist with troubleshooting process and equipment problems as necessary
Create and review manufacturing and equipment SOPs, BRs, and reports
Maintain familiarity with regulatory requirements, cGMPs and SOPs
Work on complex assignments of diverse scope and must exercise judgment within defined procedures and practices to determine appropriate actions
Expertise in aseptic processing
Excellent record keeping and documentation skills including process records and equipment use and maintenance