Lead Production Associate

We are seeking an independent, organized and energetic Lead Production Associate to be a key member of our dynamic, fast-paced development and manufacturing team. The successful candidate will primarily be responsible for cell culture, dilution cloning, and analysis of stable cell clones. Additional 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.

Preferred Requirements:
- 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

To be considered as an applicant, please submit your resume/CV referencing the specific position of interest to careers@pacificgmp.com. In addition, please provide at least 3 professional references, preferably from superiors. Applicants whose qualifications and experience most closely match the requirements of the position will be reviewed. Candidates will only be contacted for evaluative discussions. EOE.