Posting date: March 29, 2013
Manufactures products and completes associated documentation. Contributes to the transfer of new products into Manufacturing.
Produces and purifies antibodies using cGMPs. Interacts with multiple departments to develop new cell lines. Performs associated procedures using mice and in-vitro equipment. Performs analytical and functional testing of antibodies. Reviews and approves completed batch records. Maintains and analyzes lot histories for trends and discrepancies. Trains other chemists on equipment and procedures. Completes accurate PROCED transactions within timeline guidelines. Writes, reviews and modifies SOPs, work instructions and reports. Maintains, troubleshoots, and validates equipment as appropriate. Keeps dept supervisor and/or manager updated on all issues. Performs other job duties as required. Acts independently to determine methods and procedures on new assignments.
BS/BA in scientific discipline (Chemistry or Biochemistry preferred) with 2-4 years related experience and/or training. Hands on experience with HPLC and/or bioprocess equipment desired. Basic lab skills and knowledge of safety precautions. Familiarity with Quality System Regulations. Experienced in working with potentially hazardous chemicals and human source materials.
Carries out established processes under limited supervision. Receives detailed instructions on new assignments, depending on experience level. Deviations from approved procedures require authorization from supervisor or manager depending on risk.
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