Scientist TS/MS
Eli Lilly and Company
Charlottetown, Prince Edward Island, Canada
16d ago


Provide front-line support for process improvement, validation, and tech transfer projects in compliance with cGMPs, SOPs and applicable guidelines and standards.

Functions, Duties, Task :

  • Support the execution of qualification, validation, and continued process verification projects (with a primary focus on process and cleaning validation), working directly with process teams on the shop floor to ensure accurate execution.
  • Participate in equipment qualification and validation.

  • Work with manufacturing and quality teams in execution of technical protocols, development activities, and technical transfer programs.
  • 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 / OOE events.
  • Assist in preparation and critical review of validation documents, PFDs, batch records, SOPs, technical protocols and reports.
  • Provide the necessary support in internal and external audits.

  • Demonstrate strict adherence to cGMP standards and Elanco policies and procedures. Maintain Safety First and Quality Always mindset.
  • Basic Qualifications

  • BSc in Microbiology, Chemistry, Bio / Pharmaceutical Technology or equivalent scientific degree.
  • Minimum 2+ years experience in cGMP manufacturing and / or quality role(s).
  • Proven understanding of biopharmaceutical production processes and cGMP guidelines.
  • Strong oral and written communication skills.
  • Additional Skills / Preferences

  • Desirable : MSc in Microbiology, Chemistry, Bio / Pharmaceutical Technology or related field.
  • Fundamental understanding of vaccine / biotechnology production processes.
  • Process / analytical development experience a plus.
  • Apply
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