Principal Scientist, Product & Process Technology

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Why Us? At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With a global workforce, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. Job Description Summary Responsible for development, scale-up and tech transfer of new Oral Solid and Oral Liquid products to the Hobart site, and other sites as needed, from internal R&D and from external Pharma companies as a CMO service. In addition, the Principal Scientist, Product & Process Technology will use problem-solving techniques to resolve process difficulties, reduce waste, improve productivity and safety, and assist in training. The Principal Scientist will also provide technical support to site operations, maintenance, and manufacturing personnel for supported processes. Additional job duties include investigating new technologies and their application to manufacturing processes and assisting in development of products and processes for contract manufacturing projects. Job Description Technical Transfer of Acquired / CMO Products - Technical Transfer of R&D Products are Managed and Supported Responsible for meeting KPI's in supply agreement contracts with Pharma companies. Responsible for meeting all Tech Transfer project milestones within Hobart site control. Develop, write and review protocols and reports for the following batches: Product Characterization, Tech Transfer, Exhibit/Registration, and Validation. Complete statistical analysis of data. Develop/write product manufacturing instructions. Initiate and execute action items as required for OOS, Change controls, CAPA's, FMEA's. Support new process start-ups including equipment and process development. Use knowledge and practical application of materials sciences for solid and liquid dosage formulation characterization and scale-up projects. Manage development activities to ensure projects meet the development schedule requirements. Knowledge of DOE, statistical techniques for data analysis, total quality management, Six Sigma in manufacturing. Strong communication skills are required to manage projects effectively. This includes the ability to direct and motivate personnel who are not in the same department or function. Technical Aspects of Legacy Products are Managed and Supported Use problem solving techniques to resolve manufacturing issues, reduce cost, waste and improve quality with existing processes. Responsible for meeting all Tech Transfer project milestones within Hobart site control. Develop, write and review protocols and reports for the following batches: Product Characterization, Tech Transfer, Exhibit/Registration, and Validation. Complete statistical analysis of data. Develop/write product manufacturing instructions. Develop/write/execute development protocols for existing products and new product transfers. Initiate and execute action items as required for OOS, Change controls, CAPA's, FMEA's. Provide technical leadership in support of productivity improvement and cost reduction projects. Review all process changes to improve products for operation, reliability, efficiency and safety. Primary resource for resolving technical process issues. Support productivity improvements through process upgrades. Key Competencies Analytical: Uses a systematic approach in solving problems through analysis of problem and evaluation of alternate solutions; uses logic, mathematics, or other problem-solving tools in data analysis or in generating solutions; logically and thoughtfully sorts through ambiguity and alternatives with rigor and discipline that crystallizes ideas for action; goes beyond analyzing factual information to develop a conceptual understanding of the meaning of a range of information; integrates diverse themes and lines of reasoning to create new insights or levels of understanding for the issue at hand; thinks in terms of generalized models rather than concrete details. Influencing Others: Moves people toward willing involvement in a particular course of action using techniques that appeal to logic, values or emotion; presents arguments that address others' most important concerns and issues and looks for win-win solutions; involves others in a process or decision to ensure their support; identifies and proposes solutions that benefit all parties involved in a situation; accurately anticipates the implications of events or decisions for various stakeholders in the organization and plans accordingly. Innovation: Looks for new and creative ways of doing things; challenges current systems and procedures to identify break-through opportunities; looks for more than one solution; identifies correlations and relationships to solve multiple problems with one solution

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