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R&D Analytical Sr.Scientist II
Job Opportunity at
Global Personnel Search Inc
Posted on Mar 9
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.
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.
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