The QC Analyst II will contribute to the success of the operation by providing accurate, GxP-compliant analyses of clinical biopharmaceutical products and by participating in assay qualification and validation studies. Biopharmaceutical manufacturing runs typically cost in excess of 1$ million each and reach many times that for larger, phase 3 campaigns, while stability studies cost several hundred thousand dollars each, and this individual has an important role in ensuring that release and stability testing generates accurate results, without delays or compliance issues. The individual will help maintain the biochemistry laboratory systems, assist in training other analysts, help maintain SOPs and other documents, and promote an orderly and efficient laboratory workplace.
Knowledge/Skills/Abilities Required
Education: BS in biological or chemical sciences or equivalent
Experience: • Minimum of 2-4 yrs working experience in a cGMP Quality Control, analytical development, analytical transfer or validation department in a FDA-regulated industry. • Knowledge of principles, concepts, and practices in QC testing of protein biopharmaceuticals. • Hands-on experience with at least two techniques, such as HPLC, capillary electrophoresis, ELISA, or SDS-PAGE, used for analysis of recombinant proteins. • Knowledge of GxP requirements and ICH/FDA/EMA guidelines. • Ability to identify and help investigate assay and equipment problems. • Fluent in English, good written communication skills; good interpersonal skills. • Team player who can excel in a "hands-on" entrepreneurial environment. • Physical requirements: handling of laboratory equipment, chemicals, and biological materials.