Scientist, Analytical Development

5 days ago

Skipton, United Kingdom Dechra Full time
Summary

Thanks for checking out our vacancy, we're delighted you want to learn more about Dechra

Dechra are 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 2700 colleagues globally. From manufacturing to marketing, (D)edication, (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.

The Scientist Analytical Development role contributes to the successful and timely development of novel and generic pharmaceutical products, via the conduct of analytical testing of various APIs, raw materials and finished products, and associated method development, validation and transfer activities. The Scientist Analytical Development must be able to work independently and according to GMP in the conduct of bench top research and development programmes, thus contributing to the successful submission and approval of worldwide regulatory filings. The Scientist Analytical Development participates in execution of Dechra development projects and can participate in international cross-functional and cross-site project teams.

Main Responsibilities

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

* Actively contributes to planning, developing and implementation of scientifically well-designed experimental programs and demonstrates creativity and capability in pharmaceutical research and development (with support from senior colleagues as required).

* Adheres to departmental and Dechra requirements for EH&S.

* Adheres to Dechra SOP and GMP requirements.

* Accurately and contemporaneously records experimental procedures, test results and observations, and reviews data to meet corporate, regulatory and GMP requirements.

* Development, validation and transfer of appropriate analytical methods (e.g. HPLC-UV) and/or analytical testing to support characterisation of API and drug products.

* Measures key API and/or formulation physicochemical properties to support the development process and to identify the root cause of potential stability, manufacturing and performance issues e.g. pKa, pH, solubility, disintegration, dissolution, particle size, HPLC assay, related substances etc.

* Actively manages priorities and schedules experimental work etc to meet or exceed project milestones. Regularly communicates project progress, challenges and potential delays to stakeholders.

* Responsible for maintaining their training curriculum in line with departmental and company-wide SOPs and GMP regulations

  • As applicable, arranges/performs Preventative Maintenance (PM) and Performance Qualification (PQ) for equipment for which they are responsible.

* Assists in preparation of Chemistry, Manufacturing and Control (CMC) documents for Regulatory submission.

  • Actively managing working relationships through engagement with cross-functional and cross-site teams in the design and execution of studies e.g. technical services/manufacturing, clinical, regulatory, QA/QC etc.

* Reports project progress against technical and project objectives to Product Development Manager, CMC (CMC lead) and Pharmaceutical Development Manager (functional line management).

Ideal Candidate

Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We're particularly keen to hear from those who have/are:

  • Bachelor's or Master's degree in a relevant field, such as Chemistry or Pharmaceutical Sciences
  • Proven track record in analytical chemistry, with a strong practical background in HPLC (experience in other techniques such as dissolution and Karl Fischer is desirable)
  • Hands-on experience in analytical method development and/or validation (e.g., HPLC and dissolution) is highly desirable
  • Previous experience with solid dosage forms is desirable
  • Strong verbal and written communication skills in English
  • Creative problem-solving skills

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