Senior Principal Scientist - Analytical

Vacancies

Senior Principal Scientist - Analytical

Thanks for checking out our vacancy, we're delighted you want to learn more about Dechra! Dechra is a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.

Here at Dechra, our values are embedded within our culture and thrive within our family of almost 3000 colleagues globally. From manufacturing to marketing, (D)emication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do business. Expertise and leadership in the selection, interpretation of data, and validation of analytical methods for large molecule biopharmaceuticals.

The Senior Principal Scientist, Analytical Biopharmaceutical, will be the analytical technical lead for all analytical aspects and/or lead one or more global development projects in research and development through all stages required to obtain regulatory approval for sale in global markets for large molecule biopharmaceuticals. This position requires management of outside resources, leadership of project teams as well as being the technical lead in the multidisciplinary project team.

The Senior Principal Scientist, Analytical Biopharmaceutical, works closely with the internal partners in various functions as well as external and contract manufacturers and labs to ensure the products meet the expectations of multiple regulatory authorities as well as the company's Product Development goals and standards. He/she partners with technical experts in Pharmaceutical Development, Regulatory, Quality and Manufacturing, to review and create technical documents that when submitted to the relevant Health Authorities, will result in a comprehensible review.

The Senior Principal Scientist Analytical Biopharmaceutical, will provide technical expertise and leadership in the selection, interpretation of data, and validation of analytical methods for biopharmaceutical product development, technical transfer, scale up and validation.

Senior Principal Scientists may have supervisory responsibility for other (Junior) Scientists. The Senior Principal Scientist Analytical will provide technical expertise and leadership in the selection, interpretation of data, and validation of analytical methods for other junior (Scientists).

So, what will you be doing? This role has a broad and varied scope and the successful candidate will have responsibility for duties including:

The following reflects definition of essential functions for this job but does not restrict the tasks that may be assigned. Management may assign or reassign duties and responsibilities to this role at any time due to reasonable accommodation or other reasons.

• Ensure timely development of analytical methods that meet the standards of relevant regulatory authorities as well as GXP and Dechra quality standards to support animal drug applications for broad range of biotherapeutic products.
• Is overall responsible for all analytical development, validation and transfer activities from preclinical development through clinical supplies for registration studies and commercial launch.
• Applies understanding of regulations to develop analytical information necessary to support each stage of new product development.
• Proactively considers and directs next steps in analytical method development in order to meet project timelines and to ensure analytical method requirements do not become rate limiting to the next stage of development and/or registration goals.

• Provide technical leadership and oversight of analytical method development as it relates to formulation development, manufacturing and packaging of pilot, engineering, registration and process validation batches and (VICH) stability studies for large molecule biopharmaceuticals. Activities can be performed either at an internal pharmaceutical development laboratory and manufacturing site or at a contract manufacturing organization.
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