Posted: Wednesday, October 4, 2017 7:44 AM
Job DescriptionPrincipal ScientistBuffalo, NYPOSITION SUMMARY:The Principal Scientist is responsible for method transfer/method verification/co-validation of compendial and non-compendial analytical methods utilized across The company according to written procedures. The testing of routine and non-routine samples where specialized training is essential. Planning and coordination of method transfer/method verification activities in the transfer of analytical methods from the Product Development department or between The company facilities. Providing technical support to all testing laboratories within The company as well as leadership and technical expertise in projects where troubleshooting of analytical methods and instrumentation is required. The position also requires a broad and strong knowledge of analytical chemistry, pharmaceutical development, and regulatory requirements.The Principal Scientist reports directly to the Manager, Technical Services and may supervise two or three people with levels 15 and below.The Principal Scientist works closely with Product Development and QC Chemistry.PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT:A cents € cents Perform method transfer/method verification /co-validation of testing procedures utilized within the Quality Control laboratory.A cents € cents Prepare and coordinate the execution of the verification protocols to verify the vendors/USP analytical methods.A cents € cents Analyze the obtained results and prepare the verification reports after the execution of verification protocols.A cents € cents Act as liaison between the Product Development department, and the QC Chemistry laboratory for the transfer and implementation of new testing procedures.A cents € cents Identify and investigate complex problems occurring in the Analytical laboratories and provide technical support in solving the problems.A cents € cents Prepare documentation for Regulatory Submission as required.A cents € cents Review/update/approve documentation such as protocols, test methods, SOPs, raw material/finished product specification, etc.A cents € cents Participate in the orientation and training of lab employees in new analytical method techniques.A cents € cents Capable of handling the most complex projects with only general guidance.A cents € cents Establish work priorities for assignments within his/her authority and keep assignment completion on schedule.A cents € cents Function as the analytical project leader in inter-departmental meetings, related to method transfer, to communicate transfer process and technical issuesA cents € cents Additional responsibilities as required by ManagementREQUIREMENTS:A cents € cents BS with 3-5 years of related experience.A cents € cents Extensive knowledge of analytical chemistry as well as concepts in developing and validating methods to correct pharmaceutical standards.A cents € cents Extensive knowledge of parenteral formulations.A cents € cents Strong knowledge of GMPA cents € (TM) s, GLP, ICH, and USP guidance and regulations.A cents € cents Prepare documentation for Regulatory Submissions as required.A cents € cents Able to review/approve/update documentation such as protocols, test methods, SOPs, specifications, ANDA submissions, etc.A cents € cents Strong analytical and problem solving skills.A cents € cents Strong interpersonal skills and highly effective in team settings.A cents € cents Strong project management skills, written, and oral communication skills.A cents € cents Able to travel 25%Company DescriptionIncredible organization that is experiencing tremendous growth. They are extremely stable and profitable and offer multiple possibilities in terms of promotion.
• Location: Buffalo
• Post ID: 31789617 buffalo