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Sr Scientist II - Pharmaceutical Development

Category Formulations City Maple Grove State Minnesota

Upsher-Smith Laboratories, LLC seeks a Sr. Scientist II – Pharmaceutical Development in Maple Grove, MN, to play a critical role as the subject matter expert (SME) and project lead of Pharmaceutical Development. The position will be responsible for preformulation studies, formulation and process development, optimization, scale-up and manufacturing in support of USL’s growing pipeline of ANDAs and 505b2 products. The Sr. Scientist II – Pharmaceutical Development, must be able to collaborate effectively with a multidisciplinary team of scientists and engineers for formulation and process optimization and overall product development. This role requires effective communication skills which are essential for interactions with scientists and colleagues from numerous functions, serving on multi-disciplinary project teams. The specific duties and responsibilities of this position include:

  • Lead formulation development and optimization studies for solid oral dosage forms, liquids and suspensions by utilizing QbD principles;

  • Accountable for process optimization and scale-up activities, design space definition and technology transfer to commercial plant;

  • Serve as subject matter expert (SME) with internal team members and be able to clearly explain the purpose of experiments and experimental results to senior management and non-scientists within the company;

  • Prepare, review, and/or approve study protocols, study reports, manufacturing batch records, development campaign reports, CMC regulatory submission documents and SOPs;

  • Collaborate with cross functional teams including but not limited to Analytical Development, Technical Services, QA, Project Management and Regulatory to timely achieve project goals;

  • Proactively demonstrate leadership by advising and sharing knowledge and expert opinions with peers and senior management;

  • Ensure all development projects and deliverables are completed within established timelines, budgets, resources, and in accordance with regulatory, quality, and safety requirements;

  • Responsible to document all data generated in the laboratory notebooks;

  • Assist in maintaining high quality laboratory environment and comply with Health, Safety and Environmental responsibilities for the position; and

  • Perform miscellaneous technical and administrative duties as required to meet company objectives.

The position requires a Bachelor's degree in Pharmaceutical Sciences or Chemistry or foreign equivalent degree with at least 7 years of experience  developing formulations and processes for the manufacture of pharmaceutical dosage forms, which must include a minimum of 5 years of progressively responsible experience in the following areas: 1) scale-up of solid oral dosage forms, liquids and suspensions; 2) oral drug product manufacturing unit operations,  including hands-on experience with blending, wet- and dry-granulation, tableting, film-coating, milling,  and wurster coating; and 3) cGMP, regulatory and safety requirements. In the alternative, we will also accept a Master of Science degree or a foreign equivalent degree in one of the above fields and 5 years of experience as described above. Any suitable combination of education, training, or experience is acceptable. Travel (up to 10%) to visit other Upsher-Smith facilities and domestic contract partners across the United States. Please apply online at or contact Leah Schneider, Director Human Resources, Upsher-Smith Laboratories, LLC, 6701 Evenstad Drive, Maple Grove, MN 55369;

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 8090

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