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Sr. Scientist - Process Engineering

Category Technical Services City Plymouth State Minnesota

Upsher-Smith Laboratories, LLC in Plymouth, MN seeks a Sr. Scientist - Process Engineering to coordinate activities to enhance existing products/processes and implement new product launches including execution of process validation. The incumbent directs monitoring, investigations, engagement of scale-up or post approval changes to support existing products. They also render technical expertise and coordinates activities with PD for new product scale-up and manufacturing ANDA submission batches. The specific duties include:

  • Contribute to oral dosage formulation process development, process scale up and technology transfer to commercialization throughout the product lifecycle;
  • Lead change requests for resolution of production issues and deviations to ensure supply and business continuity;
  • Support continuous process monitoring;
  • Participate in troubleshooting, problem solving, failure analysis, root cause, and corrective/preventative actions;
  • Design and conduct scientific studies to investigate exception occurrences, atypical observations, change control proposals and customer complaints;
  • Understand and execute operation of pilot scale & commercial pharmaceutical manufacturing equipment without supervision;
  • Participate in formulation process evaluation early in the process development stage and in project risk assessments with Pharmaceutical Development and Operations;
  • Independently design, plan and execute scale up and robustness evaluation of formulation processes;
  • Identify and execute projects to reduce product cost, improve product quality, improve yield, and reduce material usage;
  • Collaborate with Production, Engineering, and Quality to optimize productivity, yield, product quality, and supply reliability;
  • Responsible for process technology training, SOP writing, technical reports and Validations;
  • Provide training and support to Product Development personnel during the development and scale up of formulations on cGMP equipment;
  • Conduct evaluations and experimental studies designed to develop and optimize existing product formulations and manufacturing processes;
  • Coordinate, execute and provide the transfer of technology to the manufacturing department during the process validation;
  • Be directly involved in successive phases of developmental and transfer activities including production of R&D/DOE, scale-up, registration, component changes and process validation batches in a cGMP environment;
  • Support CMO products for off-site process validation activities including the monitoring/execution of validation batches, technical support for deviations, change controls and technical audits;
  • Assist in the generation of user requirements, functional specifications, and design specifications as required for equipment related to the supported project team;
  • Tabulate and perform statistical analysis of all study data and present conclusions via technical reports and provide technical consultation and support;
  • Support internal, external and regulatory inspections including FDA, EMEA, and third party inspections; and
  • Provide technical consultation and support to both Technical Services and external departments as required.

The position requires a Bachelor's degree in a scientific or technical field (pharmaceutical science, chemistry, chemical engineering, or a related life science), or an equivalent foreign degree, with at least 6 years' experience working in product development/manufacturing or process development/manufacturing in the pharmaceutical industry. In the alternative, we also accept a Master' graduate degree in the above field, or an equivalent foreign degree, with a minimum of 4 years' of the above referenced experience. We also require two years' experience working with solid oral dosage forms, as well as two years' experience working with formulation process development, process scale up, technology transfer, or ongoing pharmaceutical commercial product support. Experience can be gained concurrently. Travel up to 25% to visit manufacturing sites and contract manufacturing organizations, to review process implementation. Please apply online at or send resume to Katherine Metzger, Upsher-Smith Laboratories, LLC, 6701 Evenstad Drive, Maple Grove, MN 55369 or

Upsher-Smith Laboratories, LLC. is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Upsher-Smith Laboratories, LLC. will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.
Job ID 7458

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