Scientist

2 weeks ago

Toronto, Canada Zany Consulting Group Full time

**_
Scientist: Analytical Sciences Immunology_**

Location: Toronto, Ontario, Canada

Responsibilities will include:

- Test Method Development: Develop new or improved immunological test methods for new vaccine entity characterization, stability testing and release. Understand requirements for test methods and project milestones by interacting with Project Teams, analytical working groups and Platform directors. Recommend and lead planning and execution of product testing and characterization according to agreed timelines and departmental quality standards. Maintain GxP compliance, where required, in all testing programs. Author, review and approve test method technical reports.
- Test Method Validation and/or Qualification: Validate and/or qualify analytical test methods in support of release, stability, and characterization testing. Design and lead the validation strategy and author or review and approve validation protocols. Present results to Project Team, platform director or regulatory agencies upon request. Author, review and approve validation reports.
- Test Method Transfer: Oversee the transfer of analytical test methods in support of release and stability testing into receiving departments. Design and approve transfer protocols. Ensure the training of analysts who receive the assay. Author, review and approve method transfers from external and internal labs to design method transfer plans and final reports.
- Supervision: Might be required to supervise direct report e.g technologist(s) or co-op student(s).

**Qualifications**:
Required Qualifications:

- Minimum University Degree Ph.D. in Immunology, Biology, or other relevant program with a minimum of 2 years relevant experience preferred; or, M.Sc. with a minimum of 3 years relevant work experience preferred.
- Specific experience in the development and validation of new immunological and immunochemical characterization methods for biomolecules/vaccines in GMP environment.
- Familiar with a broad range of analytical instrumentation and immunological techniques such as ELISA, multiple multiplex technologies such as Luminex, MSD, Biolayer Interferometry and cell-based neutralization assays.
- Experience in maintaining laboratories and equipment in cGMP and/or GLP compliance. Familiarity with testing in compliance with current regulations is preferred.
- Knowledge of documentation practices according to GMP principles.
- Excellent verbal and written communication, organizational and team skills are required.
- Familiarity with statistical analysis.
- Demonstrated supervisory/leadership skills are required.

H1iEX8mA2Y

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