Senior Research Associate - (FY09-44)

Job Description:
The Senior Research Associate position requires experience in chromatographic and wet chemistry techniques as well as the ability to assist in the development, validation, and transfer of new analytical methods. The senior research associate is expected to work independently when setting up and executing experimental procedures, coordinate and prioritize sample testing, work efficiently, document results, and communicate findings to the team in a timely manner. The Senior Research Associate will also be responsible for writing protocols, development reports, SOP’s, train others on analytical techniques, be familiar with USP/NF analytical procedures, and have an understanding of cGMP’s and ICH guidelines.

KEY DUTIES:
• Perform and record analyses as assigned on a daily basis
• ICH Guidelines and Compendial Requirements
• Adhere to cGMP’s in all work practices
• Attend training sessions as appropriate.
• Assist in maintaining a clean, safe workplace on a daily basis.
• Review peer's work as needed.
• Review revisions to procedures as needed.• Submit changes to SOPs as needed.
• Write and disseminate technical data summaries and reports.
• Train other colleagues in methods and procedures.
• Write Method Qualification/Validation Protocols and Reports
• Technically support the development of new technologies
• Troubleshoot technical problems for development


Minimum Education & Experience Requirements:
Bachelors Degree in Chemistry with 4+ years of experience or Masters Degree in Chemistry with 1+ year of experience. Other fields of specialty in Sciences are also acceptable provided sufficient chemistry coursework is completed.

Knowledge/Skills Needed:
• Store, handle, and dispose of chemicals that they work with.
• Use and maintain the equipment assigned to them to operate.
• Follow written procedures.
• Oral and written communications
• Maintain laboratory notebook and records in accordance with GMP including timely recording of information and review.
• Respond promptly to changing priorities.
• Determine when the results of an experiment are not acceptable and take appropriate action.
• Perform mathematical calculations.
• Train others to perform laboratory procedures.
• Basic chemical reactions and equilibria.
• The theory and practice of HPLC.
• The theory and practice of capillary GC.
• Operate chromatographic data acquisition and analysis software.
• The application of statistical concepts for Analytical Chemistry
• Operate specialized analytical instrumentation such as GPC or particle size analyzer.
• Operate and understand theory of more sophisticated instruments such as DSC, Karl Fischer titrator and FTIR spectrophotometer.
• Experience with method qualifications/validations and transfer validations.
• Ability to function in a chemical laboratory environment; should have no known sensitivities to chemicals present in the laboratory and no health conditions that preclude their working in a chemical laboratory environment.

Personal Attributes Needed:
• Ability to work hard and contribute to an energetic working environment.
• Proactively achieves results for the best of the organization.
• Willingness to learn new things.
• Ability to function in a small company atmosphere.
• Ability to cope with a rapidly changing work environment.
• Commitment to teamwork.
• Commitment to continuous improvement in all areas.
• Ability to focus attention to details and ensure high quality work.
• Ability to work safely; seek out and encourage safe practices.