This position will provide process support to Plasma IgG Manufacturing including Quality Systems compliance, technical operations such as Process Automation and CIP Systems and provide training related to production process. The successful candidate should have experience with LIMS, SAP applications. This position will also continuously monitor the manufacturing operation to look for process optimization / debottlenecking opportunites and make technical recommendations/changes as deemed necessary. Expedites and solves problems relative to the manufacture of immune globulin products, which may involve the gathering of information from manufacturing, quality control, and/or regulatory affairs as needed to address compliance requirements.
Knowledge of GMP, FDA and EU regulations as well as knowledge of antibody purification. Intermediate word processing and spreadsheet computer skills. The ideal candidate will be a team player and be well organized.
Bachelor's degree in biological or life sciences. Five to seven years in a regulated plasma processing manufacturing environment. Experience must include exposure to the quality assurance, regulatory, and manufacturing arenas.