R&D Analytical Sr.Scientist II
Job Opportunity at Global Personnel Search Inc

Posted on May 8

http://www.gpsrecruit.com    630-768-9191

Location: Columbus, OH
Job Type: Full Time
Job ID: W4125797

Analytical Scientist

Columbus, OH


Position Description:

This Ph.D. Analytical Scientist (R&D) position will be responsible for leading the project from feasibility phase to commercial launch. We are ready to interview candidates for multiple openings in the company.

Essential duties and Responsibilities 
  • Develop, optimize, and validate stability indicating methods for new and existing drug products and raw materials utilizing primarily HPLC and GC.
  • Write method development reports and validation protocols/reports that align with FDA/ ICH Guidelines. 
  • Lead technical transfer services of analytical methodologies from the research and development environment to commercial application (i.e. Quality Control).
  • Attend department management team meetings and schedule work to align with department objectives.
  • Plan and execute requisite lab work to answer FDA deficiency questions/Complete Response Letter for submitted ANDA.
  • Draft Raw Material and Finished Product specifications and pertinent documents for exhibit batches.
  • Document findings, work on closing open investigations (deviations, OOS etc) and write standard-operating procedures (SOPs).
  • Mentor junior level scientists and chemists on method development and validation activities.
  • Ensure all work is performed and documented in accordance with existing company policies, procedures, Current Good Manufacturing Practices, health and safety requirements.
  • Perform any other tasks/duties as assigned by management.
  • We all must embrace the QUALITY culture.
 Requirements:
  • Master Degree in Analytical Chemistry required, Ph.D. preferred.
  • Minimum 8 - 13 years Pharmaceutical industry experience in method development and validation required.
  • Demonstrated expertise with HPLC, GC, IC, LC-MS instrumentation.
  • Experience managing multiple projects simultaneously.
  • Strong technical writing skills required.
  • Excellent organizational, interpersonal and communication skills (oral and written).
  • Proficiency in Microsoft Office word and excel required.
IND123
 
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