To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #03079

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 II Minneapolis, Minnesota Salary Highly competitive package, commensurate with experience Responsibilities 1) Provide scientific advice as well as review and direct assigned Analytical Development Department projects 2) Develop analytical methodology to support Product Development functions 3) Participate in method development (literature research, analytical investigations, and validation as per cGMP) 4) Clean validation support, technology transfer to Quality Control, stability testing, competitive product de-formulation and formulation support. 5) Prepare relevant SOPs, validation, stability and product investigation reports 6) Assist the Analytical Development Manager on high-level scientific issues 7) Provide scientific direction to the Analytical Development Group regarding methods development and validation 8) Coordinate a consistent analytical development strategy for the department 9) Assist in reviewing 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) Advise on corrective actions prior to reviewing by the Analytical Development Manager 11) Assist in reviewing OOS and analytical training reports generated by Product Development personnel 12) Coordinate and/or review all Product Development analytical equipment purchases, etc. 13) Analyze competitive products with respect to formulation and stability to support formulation of company's new products 14) Research and develop analytical methodology for developing company's new products and related raw materials 15) Emphasize High Performance Liquid Chromatography (HPLC) by employing a variety of analytical techniques 16) Validate the methods as per company SOPs and cGMP 17) Interface with Quality Control to communicate method development/validation plans and progress 18) Ensure final methods that will be compatible with Quality Control systems 19) Interface with Quality Control to coordinate smooth technology transfer of new testing methods 20) Perform stability testing on experimental laboratory batches to support formulation studies 21) Perform stability testing for new company products (as required) for submission of abbreviated new drug applications 22) Investigate company products in development to optimize formulation relative to active ingredient stability and other factors 23) Assist Quality Control and Production in developing methods required for cleaning validation of new products 24) Perform testing to complete process validation for new products 25) Prepare or assist in preparing and/or reviewing SOPs and technical reports as related to Product Development 26) Evaluate, select and apply standard scientific techniques, processes and criteria using judgment in making minor adaptations and modifications 27) Investigate a limited number of variables to achieve clear and specific project results within a narrow focus area 28) Handle work that involves conventional types of plans, surveys, structures, etc. with relatively few complex features for which there are no precedents 29) Receive instruction on specific assignment objectives, technical assistance on complex features and possible solutions Requirements 1) BS, MS or Ph. D. in Chemistry with minimum 5, 3 or 1 year of experience respectively, in a pharmaceutical analytical laboratory 2) Experience in using HPLC, GC, Dissolution and USP methods 3) Good leadership skills within group 4) Ability to provide a high level of scientific judgment