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Job #02802

About our client Our client is a biopharmaceutical manufacturing and service company focusing on industry-scale manufacture of proprietary and generic peptides and specialty chemicals, used as active pharmaceutical ingredients (APIs), contract research and manufacturing services for pharmaceutical, biotech and research organizations in the biopharmaceutical area, fill/finish and formulation development for peptide, protein and other injectable drugs, and manufacturing and marketing peptide, protein and other biopharmaceutical drug products. Position Location Senior Analytical Quality Control Chemist Augusta, Georgia Salary Highly competitive package, commensurate with experience Responsibilities 1) Develop and validate analytical methods relating to the production of phase I, II and III APIs 2) Compile validation data into comprehensive reports 3) Apply creative ability and specialized knowledge of methods to solving product analytical problems (may include assay, impurity, cleaning and other applications) 4) Organize, evaluate and draw conclusions from experimental data 5) Take mature technical judgments 6) Ensure that analytical methods are accurate and in compliance with FDA, cGMP and corporate requirements 7) Identify and evaluate new analytical technology to be applied to product analysis with a primary emphasis to save the cost of testing in QC laboratories 8) Maintain familiarity with relevant literature, maintain contact with instrument vendors 9) Prepare reports and technical papers for internal or external presentation 10) Communicate with other departments and sections 11) Participate in discussions and meetings for the purpose of exchanging ideas in relevant areas of interest 12) Act as the department representative at program or project meetings 13) Communicate new ideas and approaches to appropriate personnel 14) Provide guidance (scientific and administrative) to junior analytical chemists 15) Manage whole projects (establish schedules, project plans and direct activities of other chemists and non-chemists) as well as provide training and development for others 16) Communicate with peers proactively and cooperatively 17) Handle laboratory investigations of OOS and OOT data 18) Communicate with the management by proactively keeping them informed of results, of obvious and subtle problems and of likely potential problems, alternatives and their consequences 19) Write/co-author memos and scientific reports in supporting regulatory submissions and regulatory field alerts 20) Support quality control and manufacturing documents Requirements 1) BS in Science or a related degree with 5 – 8 years of experience, or MS in Science or a related degree with 3 – 6 years of experience 2) Knowledge of and familiarity with compliance requirements within cGMP, safety and regulatory environments 3) Operational knowledge of analytical instrumentation like HPLC, GC, LC-MS, FTIR, UV-VIS equipment and data stations 4) Demonstrated computer literacy, including spreadsheets and databases (preferably in a Windows environment) 5) Ability to troubleshoot analytical methods as well as develop and validate new analytical methods