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Senior Process Scientist TS/MS
Senior Process Scientist TS/MS
State / Province
Prince Edward Island
Ensures oversight of product(s) related technical process(es) and quality aspects to maintain and improve process capability, quality and compliance. Provide front-line support to vaccines manufacturing, process improvement, and validation, in compliance with cGMP and/or applicable guidelines and standards. Functions, Duties, Task :
47365BR Maintains overview of USP/DSP process(s) performance through data trending, from raw materials to finished pack, to ensure processes are in control and capable. Use scientific and statistical analysis tools to improve process understanding, ensure manufacturing processes are operating in a state of control, and identify opportunities for process improvements. Participate in product and process related technical investigations and root-cause analyses of process deviations, complaints, and OOS events. Liaises with other functions (e.g. Engineering, QA, Operations) to ensure complete and concise root cause investigation and resolution. Ensures support in resolution of technical and compliance issues, technical answers to QA, to internal inspection bodies or to Health Authorities. Reviews Annual Product Reviews (APRs)/Product Quality Reviews (PQRs). Ensures that technical customer complaints and deviations have robust CAPAs and that systematic issues are identified across the site. Ensures products’ processes are in a constant state of validation Support the execution of qualification, validation, and continued process verification projects (with a primary focus on process and cleaning validation) Work with manufacturing and quality teams in execution of technical protocols, development activities, and technical transfer programs. Author or assist in preparation and critical review of validation documents, PFDs, batch records, SOPs, technical protocols and reports. Define continuous improvement plans and oversee the execution (technical lifecycle management). Demonstrate strict adherence to cGMP standards and Elanco policies and procedures. Maintain “Safety First and Quality Always” mindset.
Basic Requirements: Education and Experience
MSc. in Microbiology, Chemistry, Bio/Pharmaceutical Technology or related field. Desirable PhD in the above or equivalent. Minimum seven years’ experience in operations / manufacturing science and technology / technical development / Quality. Proven understanding of biopharmaceutical production processes and cGMP guidelines. Fundamental understanding of microbial fermentation, chromatography and ultrafiltration unit operations. Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities. Fundamental understanding of standard pharmaceutical analytical testing. Expert in reviewing and writing technical reports. Strong project management skills, strong communication skills.
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