Lead Manufacturing Associate

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 is acting as an Employment Agency in relation to this vacancy.