Job Description:
Our MA client needs a Quality GMP consultant in Massachusetts to support their Cell & Gene Therapy product line. This is role is going to be centered around Clinical manufacturing for exosomes, and due to the fact that there are no current regulations around exosome manufacturing, this candidate will need to take a risk based approach when making decisions for the GMP manufacturing. Biotech experience required; Cell & Gene Therapy preferred (no small molecule/pharma). This is a very dynamic role as the day to day will change, but candidate can expect to be reviewing and executing batch records, fielding questions from internal teams, manage vendors, join project team calls with CMOs and contract testing orgs, getting involved in deviations, etc. They need this person to have at least 7-10 years of experience and to be within commutable distance from the site for when onsite troubleshooting is necessary. Additional experience with auditing, training management, and quality systems (managing, training, and creating trace matrices) is preferred. They currently use Zen QMS and Sharepoint as their main systems.
Skills:
GMP, risk based, Cell & Gene Therapy, Biotech, quality systems management
Education:
experience outweighs degree
MA: Sr Consultant GMP QA Operations (232246)
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