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Job #03080

About our client Our client is a rapidly expanding generic pharmaceutical company based in Minneapolis. They focus on the high-volume manufacturing of generic pharmaceuticals and OTC specialty products. Founded in 1977, they now have 250 employees, an 180,000 square feet facility and revenue of $120M this year alone. This is an excellent opportunity for the right person to join a stable, profitable and rapidly growing company! Position Location Analytical Scientist III Minneapolis, Minnesota Salary Highly competitive package, commensurate with experience Responsibilities 1) Provide high-level scientific advice as well as review and direct assigned Analytical Development Department projects 2) Develop, validate and apply methods for testing raw materials and formulations for FDA submissions 3) Oversee literature research, chemical characterization of API and drug products 4) Manage method development and stress studies, analytical investigations and method validation as per cGMPs 5) Handle cleaning of validation support, method transfer to Quality Control, development stability studies and possible interaction with CROs on assigned analytical projects 6) Prepare relevant SOPs 7) Handle validation, stability and product investigation reports to support laboratory GMP functions and FDA submissions 8) Advise the Analytical Development Manager on high-level scientific issues and provide scientific orientation on assigned analytical development projects regarding methods development 9) Review scientific methods, validations, reports and analytical product specifications prior to reviewing by the Analytical Development Manager to ensure high quality work is generated and reported 10) Review OOS investigation and analytical training reports generated by Product Development personnel and advise on corrective actions prior to reviewing by the Product Development Manager 11) Make recommendations on analytical equipment purchases, etc. 12) Analyze competitive products with respect to formulation and stability to support formulation of new company products 13) Research and develop analytical methodology (as required) for the development of new company products and related raw materials 14) Emphasize High Performance Liquid Chromatography (HPLC), GC (headspace), Dissolution and AA 15) Validate the analytical methods as per company SOPs and cGMPs 16) Interface with Quality Control and other departments to communicate method development/validation plans and progress as appropriate to ensure final methods will be compatible with quality control systems 17) Interface with Quality Control to coordinate smooth technology transfer of new testing methods 18) Perform stability testing on experimental laboratory batches to support formulation studies 19) Perform stability testing for new company products (as required) for submission of abbreviated new drug applications 20) Assist Quality Control and Production in developing methods required for cleaning method validation of new products 21) Perform testing necessary to complete process validation for new products 22) Prepare or assist in preparing and/or reviewing SOPs and technical reports as related to Analytical Development 23) Devise new approaches to the problems encountered and work within conventional practices 24) Receive technical guidance on unusual or complex problems 25) Plan, schedule, conduct or coordinate detail phases of work for a part of a major project to total project of moderate scope Requirements 1) BS, MS or Ph. D. in Chemistry with minimum 8, 5 or 3 years of experience respectively, in a pharmaceutical analytical laboratory 2) In-depth experience in using modern HPLC, GC, dissolution and USP methods 3) Experience in AA, particle size analyzer, DSC/TGA, LC/MS and NMR 4) Excellent knowledge of all conventional aspects of the subject matter 5) Knowledge of precedents in the specialty area and principles and practice in related specifics 6) Good leadership skills within the group 7) Ability to provide a high level of scientific judgment 8) Ability to perform independent judgment in evaluating, selecting, adapting and modifying standard techniques, processes