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Scientist, Technical Services - Lyophilized Vials

ROLE SUMMARY: The primary role of the Scientist, Technical Services - Lyophilized Vialed Product, is to: Identifying and implementing commercial product/process improvements for lyophilized vialed parenteral products. Technology transfer to new/different manufacturing areas, to/from current facility. Participating in start-up efforts of new equipment or processes in manufacturing. Develop risk assessments, risk mitigation strategies and risk plan. Establish experimental protocols, conducting experiments, analyzing results, and documenting the information. Provide technical leadership in the investigations of lyophilisation-related challenges to determine root cause and implement appropriate corrective and preventive actions. Ensure project deliverables meet their quality, safety, and functional goals, and satisfy the customer. Serving as a scientific and technical representative for process-/product-related highly technical challenges. Partnering with manufacturing to meet the production schedule, ensure commercial supply , uphold quality standards and driving towards zero defects Assisting in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and validation to implement those changes. Reviewing/providing feedback and technical/scientific support on project deliverables, i.e. remediation initiatives, planreports, etc. Develop technical impact assessments for all changes and develop execution plan. BS or MS in Mechanical, Chemical or Industrial Engineering or Chemistry/Pharmaceutical Science is required.  Plus 5+ or more years in a pharmaceutical product and/or manufacturing facility. OR PhD in Mechanical, Chemical or Industrial Engineering or Chemistry/Pharmaceutical Science with experience at a pharmaceutical product and/or manufacturing facility preferred. Expertise in lyophilization and parenteral product manufacturing processes required. Familiar with global parenteral product Regulatory Affairs CMC requirements. Excellent communication skills and attention to details. BS or MS in Mechanical, Chemical or Industrial Engineering or Chemistry/Pharmaceutical Science is required.  Plus 5+ or more years in a pharmaceutical product and/or manufacturing facility. OR PhD in Mechanical, Chemical or Industrial Engineering or Chemistry/Pharmaceutical Science with experience at a pharmaceutical product and/or manufacturing facility preferred. Expertise in lyophilization and parenteral product manufacturing processes required. Familiar with global parenteral product Regulatory Affairs CMC requirements. Excellent communication skills and attention to details. Role Responsibilities: Plays leadership role in technical teams for discrepancy and investigation resolution, equipment and process validation activities, training on new process technologies and on significant changes to manufacturing procedures Proposes process/product/device improvement opportunities and/or corrective actions to increase yield, maximize capacity, reduce costs and decrease process variability while maintaining regulatory compliance. Provides technical support for equipment and process validation activities conducts process overview training to support implementation of new process technologies and assists in defining the scope of capital projects. Leads process/product/device improvements, creates data packages by justifying and outlining recommendations for changes to or improvements in production processes and collaborates with technical staff to implement process technology initiatives. Supports change management and implementation for changes to device products or the associated manufacturing processes and associated systems, provides training for technical staff on these changes. Executes laboratory runs and writes technical reports summarizing laboratory results, generating necessary lab data to support product impact assessments during discrepancies and investigations. Last Date to Apply for Job: December 31, 2018 4714545
Salary Range: NA
Minimum Qualification
5 - 7 years

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