Upsher-Smith Laboratories, LLC is seeking a Sr. Scientist II - Process Engineering to share time between Maple Grove, MN, and Plymouth, MN. The Sr. Scientist II - Process Engineering coordinates activities related to the enhancement of existing products/processes and implementation of new product launches including execution of process validation. Directs monitoring, investigations, engagement of scale-up or post approval changes to support existing products. Renders technical expertise and coordinates activities with Pharmaceutical Development (PD) for new product scale-up and manufacturing ANDA submission batches. Provides leadership and direction to Process Development team members. The essential duties include:

• Contributes to oral dosage formulation process development, process scale up and technology transfer to commercialization throughout the product lifecycle.
• Leads change requests for resolution of production issues and deviations to ensure supply and business continuity.
• Supports Continuous process monitoring.

• Participates in troubleshooting, problem solving, failure analysis, root cause, and corrective/preventative actions.
• Investigates deviations to determine product impact.

• Provides leadership and work direction to Process Engineering team members.
• Designs and conducts scientific studies to investigate exception occurrences, atypical observations, change control proposals and customer complaints.
• Understands and executes operation of pilot scale and commercial pharmaceutical manufacturing equipment without supervision. Duties will include the evaluation of formulation and process to determine their effects in relation to final product specification. This includes evaluating equipment set points and process parameters for their impacts on final product characteristics.
• Collaborates with PD in formulation process evaluation early in the process development stage and participates in project risk assessments with Pharmaceutical Development and Manufacturing Operations.
• Independently designs, plans and executes scale up and robustness evaluation of formulation processes.
• Identifies and executes projects to reduce product cost, improve product quality, improve yield, and reduce material usage. Collaborates 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.
• Provides training and supports to Product Development personnel during the development and scale up of formulations on cGMP equipment.
• Conducts evaluations and experimental studies designed to develop and optimize existing product formulations and manufacturing processes.
• Coordinates, executes and provides the transfer of technology to the manufacturing department during the process validation.
• Handles 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.
• Supports CMO products for off-site process validation activities including the monitoring/execution of validation batches, technical support for deviations, change controls and technical audits.
• Assists in the generation of user requirements, functional specifications, and design specifications as required for equipment related to the supported project team.
• Tabulates and performs statistical analysis of all study data. Presents conclusions with clear, logical, scientific explanations and justifications via technical report.
• Provides technical consultation and support to both Technical Services and external departments as required.
• Supports internal, external and regulatory inspections including FDA, EMEA, and third party inspections.

The position requires a Bachelor's degree in Pharmaceutical Science, Pharmaceutics, Chemistry, Chemical Engineering, or a related life science, with at least eight (8) years of progressively responsible experience working in product development/manufacturing or process development/manufacturing in the pharmaceutical industry. In the alternative, we accept a Master's degree in one of the above fields with at least six (6) years of progressively responsible experience working in product development/manufacturing or process development/manufacturing in the pharmaceutical industry. 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. Overnight travel up to 10% to visit manufacturing sites and contract manufacturing organizations across the US to review process implementation required. Must reside within normal commuting distance of the Twin Cities metropolitan area as the position will be required to work onsite in our Plymouth and Maple Grove, MN manufacturing facilities. Please apply online at http://www.upsher-smith.com/about-us/careers/ or send resume to Ramin Rigi, Upsher-Smith Laboratories, LLC, 6701 Evenstad Drive, Maple Grove, MN 55369 or Ramin.Rigi@upsher-smith.com.

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.