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Senior Process Scientist TS/MS

Senior Process Scientist TS/MS
Prince Edward Island
North America
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:

  • 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.
  • 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.