Lead Manufacturing Associate

Details: The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, genetic information or any other characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 844 895-8598 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position. Position Title: Lead Manufacturing Associate Position is temp to hire The Lead Manufacturing Associate is a hands-on position that provides oversight in our Cell Culture Group, & operates process and ancillary equipment, in compliance with CGMP regulations, to support the production of Obizur, a hemophilia therapeutic drug . Functions in a leadership role for the assigned shift performing such tasks as: o Schedule personnel to ensure coverage of all required processes o Communicate process and personnel issues to supervisor o Act in a supervisory capacity in the absence of supervisor Operate process equipment in cell culture including manufacturing performing processes such as: o expansion of mammalian cells in roller bottles and flasks o automated and manual cell culture systems supporting cell growth, expansion, and harvesting systems o viral inactivation mixing systems Operate BSC?s, microscopes, incubators, mixing equipment, automated cell culture harvesting equipment, conductivity meters, autoclaves, and other manufacturing equipment Independently complete required documentation and guide other operators on proper GMP recording of entries and comments in batch records, forms and protocols Train less experienced or new staff on new procedures Author complex explicit documentation for new procedures as well as for current procedures Initiate Document change requests; author and revise manufacturing documentation Initiate and close deviations and CAPAs of moderate complexity and scope Initiate and close planned changes and change controls of moderate complexity and scope Perform real time Production Batch Record review prior to submission to supervisor. Clean equipment and parts for use in CGMP operations using manual systems and Glassware washer. Prepare equipment and assemblies to be autoclaved Minimum Acceptable: BS (or equivalent) in scientific discipline plus a minimum of three (3) to five (5) years of related biological manufacturing experience in a CGMP environment; or, an AS with 5-7 years of experience; or, HS Diploma 7-9+ years. Specific experience in cell culture is a must. About Aerotek: Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services. Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit aerotek.com .
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