Job Description

Role Hybrid...
MUST HAVE- Experience in performing immunology assays (example: ELISA, cell-based bioassay methods)

Responsibilities:

• Design, execute, and interpret experiments to develop, validate, transfer and troubleshoot quality procedures and test methods. Carries out investigations and produces documentation.
• Develop and authors complex, explicit documentation for new and current procedures, validation protocols and technical reports incorporating appropriate use of statistics.
• Solve assay/process problems.
• Provide contributions to the understanding and interpretation of results and how they impact the design of subsequent experiments.
• Identify potential problems and proactively suggests technical solutions based upon analytical expertise and knowledge of product/process.
• Coordinate completion of specific project tasks with other departments.
• Contribute to development of project strategy in consultation with supervisor and/or colleagues
• Work is performed under minimal supervision. Independently determines and develops approach to solution
• Represent the organization in providing solutions to difficult technical issues associated with specific projects.

Responsibilities in test method validation include:

• Lead method optimizations, improvements and revalidation
• Lead ALCM method assessment periodic review
• Address method validation gaps identified during ALCM method assessment periodic review
• Address validation/testing gaps for new products
• Support/Lead replacement of test methods with new test/technology
• Support/Lead implementation of new tests/technology
• Support/Lead post approval commitments and other regulatory commitments

Qualifications:

• Immunology/Biology - BSc with minimum of 5 years of relevant experience, or MSc with a minimum of 3 years of relevant experience
• Scientist skill set should include:

o Outstanding technical writer (protocols, reports, investigations)
o Experience in test method development and troubleshooting
o Experience in performing immunology assays (example: ELISA, cell-based bioassay methods)
o Experienced in conducting scientific investigations, including OOS investigations and CAPAs
o Technical Skills (including various computer programs and systems)
o Outstanding Organization Skills (required to work on multiple projects at the same time)

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