• Conduct routine and non-routine analysis of raw materials, in process, and finished formulations according to standard operating procedures.
• Act independently to determine methods and procedures on new assignments.
• Perform experiments in accordance with written procedures and/or under the direction of a supervisor.
• Manage equipment calibrations/qualifications with minimal supervision.
• Assist in the development and training of peers and less skilled employees in the execution of analyses and/or the use of specialized equipment.
• Perform microbiological and/or chemical analyses of product to ensure stability.
• Compile data for documentation of test procedures that may include microbiological and chemical assays, stability program testing and formulation studies.
• Calibrate and maintain lab equipment.
• Participate in the preparation of investigations, summaries and reports.
• May lead in developing test methods.
• Review data obtained for compliance to specifications, report abnormalities and may lead root cause investigations.
• Write, revise and update standard operating procedures as needed.
• May perform special projects on analytical and instrument problem solving.
• Apply knowledge of good manufacturing practices, good laboratory practices and good record keeping practices on a daily basis.
• Follow written test methods and protocols.
• Summarize and/or process data and prepare tables and graphs for the completed testing. Identify problems, e.g. out of trend data.
• Demonstrate good understanding, with a working knowledge, and ability in primary scientific discipline. Trouble shoot a wide selection of instruments (e.g. balances, FTIR, HPLC, GC, Delivered dose, cascade impactors, environmental monitoring equipment, Vitek) or is a specialist in a scientific field such as metrology or technical documentation.
• Summarize and/or process data and prepare tables and graphs for submission to regulatory agencies.
• Ability to recognize issues and develop strategy to proceed forward with supervisor’s input.
• May determine methods and procedures on new assignments and may provide guidance to other lower-level personnel.
• Represent the group at appropriate meetings.
• Responsible for observing all Company, Health, Safety and Environmental guidelines.
• Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.

• BS Degree in Chemistry with 4-6 years or MS Degree with 2-4 years or PhD Degree with 0-2 years related experience.
• A working understanding of /experience in GMPs and regulatory guidance.
• Ability to think analytically along with good communication, organizational and interpersonal skills.
• Must have knowledge of Empower.
• Must have experience in HPLC analysis and other required analytical techniques.
• Proficient in the use of a word-processing and spreadsheet program.
• Understanding of GMPs and regulatory guidelines as they relate to the pharmaceutical products preferred.
• Good analytical chemistry and quantitative and qualitative analytical skills.
• An understanding of the basic statistical concepts and working knowledge of one or more statistical and other technical software packages.
• Excel, Word and Power Point skills.

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