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Job Information

Lilly Scientist TS/MS in Charlottetown, Prince Edward Island

Job Category:

Manufacturing

Type of Employment:

Full-Time Employment - FTE

Responsibilities:

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 Qualificiations:

• 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.

Additional Information:

Company Overview:

Posted Date:

Keyword:

Region: North America

City: Charlottetown

State: Prince Edward Island

Country: Canada

Location Details:

Req Id: 47366BR

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