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Sr. Scientist - Process Engineering & Process Validation

Category Technical Services City Plymouth State Minnesota

The Technical Services Sr. Scientist - Process Engineering & Process Validation coordinates activities related to the enhancement of existing products/processes and implementation of new product launches including execution of process validation and continuous process verification. Directs monitoring, investigations, engagement of scale-up or post approval changes to support existing products. Render technical expertise and coordinates activities with Pharmaceutical Development for new product scale-up and manufacturing ANDA submission batches. Leads technical transfers between internal sites or to a CMO site.

Essential Job Duties:

  • Contributes to oral dosage formulation process validation, continuous process verification, process scale up and technology transfer throughout the product lifecycle.
  • Responsible for process technology training, SOP writing, technical reports and Validations.
  • Has familiarity with cleaning validation and packaging processes.
  • Performs risk assessment to determine level of continuous process verification required during launch/validation activities.
  • Knowledge and experience with FDA requirements for commercialized products and awareness of current industry technology and validation practices.
  • Support CMO products for off-site process validation activities including the monitoring/execution of validation batches, technical support for deviations, change requests and technical audits. 
  • Participates in troubleshooting, problem solving, failure analysis, root cause, and corrective/preventative actions. Ability to investigate deviations to determine product impact. 
  • Design and conduct scientific studies to investigate exception occurrences, atypical observations, change request proposals and customer complaints.
  • Lead change requests for resolution of production issues and deviations to ensure supply and business continuity.
  • Collaborates with Production, Engineering, and Quality to optimize productivity, yield, product quality, and supply reliability.
  • Understand and execute operation of pilot scale & 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.
  • Ability to independently design, plan and execute scale up and robustness evaluation of manufacturing processes.
  • Responsible for identifying and executing projects to reduce product cost, improve product quality, improve yield, and reduce material usage.
  • 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 including training where appropriate.
  • Directly involved in successive phases of developmental and transfer activities including production of R&D/DOE, scale-up, registration, component changes, process validation batches in a cGMP environment.
  • Provides work direction and mentoring to Technicians/Scientists within the group.
  • Tabulate and perform statistical analysis of all study data.  Present conclusions with clear, logical, scientific explanations and justifications via technical report.
  • Assist in the generation of user requirements, functional specifications, and design specifications as required for equipment related to the supported project team.
  • Support internal, external and regulatory inspections including FDA, EMEA, and third party inspections.

Education & Experience requirements:

Bachelor’s degree in a scientific or technical field (pharmaceutical science, chemistry, chemical engineering, or a related life science) with at least 6+ years of experience working in product development/manufacturing or process development/manufacturing in the pharmaceutical industry OR a Master’s degree in the above fields with a minimum of 4+ years of the above referenced experience. Must have 2+ years of experience working with solid oral dosage forms as well as 2+ years of 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. Project management experience/skills strongly preferred.

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 7427

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