Lead Analytical Scientist

Teva

Waterford, Ireland

The role is an exciting opportunity to work within the dynamic and ever changing environment of R&D as part of the product development team for a global leader in the pharmaceutical sector. Teva Respiratory R&D is seeking a highly innovative, data-driven and self-motivated individual with strength in analytical pharmaceutical product development and the ability to manage and drive projects. If you’re dedicated, energetic and detail-oriented, this could be the perfect role for you!

A Day in the Life of our Lead Analytical Scientist

Lead development and validation of analytical methods for analysis of drug substance/drug product.
Lease and coordinate with the formulation team to deliver analytical support for early development/DOE/stability batches.
Lead technical investigations and develop approaches to solve wide ranging, interesting and complex problems.
Manage outsourced analytical activities at contract facilities and provide technical guidance for method development and pharmaceutical performance testing.
Write/review technical documents for regulatory submissions and associated correspondence with regulatory agencies.
Ensure that all work is carried out in compliance with the required standards conforming to company, cGMP, GLP, SOP, regulatory, H&S and environmental requirements.
Work with cross-functional departments’ e.g Operations, QC, QA, Regulatory Affairs and Operations to address deficiencies, fillings of new regulatory applications etc.
Taking ownership and responsibility from start to finish of individual projects and tests.

Who we are looking for

Are you….

Educated to Degree or Masters Level (PhD advantageous) in chemistry (or related subject) with strong’ industry experience (5 years plus),

Do you have?

Experience leading the development and validation of analytical methods for UPLC/HPLC and GC is essential. .
An understanding of requirements for implementing a QbD approach to method validation and method lifecycle management.
Experience delivering technical presentations. Knowledge of global regulatory and compliance requirements.
Previous experience of writing/reviewing technical documents.
Good planning and organising skills & adaptable to changing priorities.
Strong communication and interpersonal skills with previous experience in cross-collaboration

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