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Technical Specialist - Analytical

Please Note: The application deadline for this job has now passed.

Job Introduction

Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra Pharmaceuticals PLC.

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 2000 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 Opportunity 

The Technical Services Analytical Specialist must be able to work independently across the scope of development activities i.e. from bench top analysis, working with internal and third party development groups to ensure smooth transition into routine QC.  The  Technical Services Analytical Specialist should also support regulatory requirements for successful submission and approval of filings. A key aspect of this role is the technical leadership, coaching and co-ordination of colleagues in QC and Technical to help achieve their respective project and development goals. The Technical Services Analytical Specialist is a member of cross-functional and cross-site project teams and participates in design and execution of Dechra development and remediation projects.

Role Responsibility

The Challenge

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

  • Plans, develops, and implements scientifically well-designed experimental programs and demonstrates creativity and capability in pharmaceutical research and development.
  • Independently designs, develops, optimizes and executes analytical laboratory experiments.
  • Develop, validate and transfer (as applicable) analytical methods, suitable for progressive stage of pharmaceutical development.
  • Measures key API and/or formulation physicochemical data 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 internally and at Third Party Laboratories 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.
  • Troubleshoots analytical issues that may occur during product remediation, validations, manufacturing processes, tech transfer/scale-up.
  • Development of suitable and robust analytical methods based upon quality by design (QBD) concepts
  • Manages relationships and output of internal and/or contract labs that may be carrying out development activities on company’s behalf.
  • Provides technical guidance in analytical activities to less experienced colleagues.
  • Assists in the preparation of Chemistry, Manufacturing and Control (CMC) documents for Regulatory submission.
  • Independently authors and reviews technical documents, such as protocols, technical reports, test methods, and operating procedures.
  • Support ad-hoc investigations and provide technical support and expertise, as necessary
  • Author Risk Assessments on an ad-hoc basis for processes, procedures and systems to ensure risks are identified and appropriately managed, including mitigation via corrective and preventive actions (CAPAs), where appropriate.
  • Accurately and contemporaneously records experimental procedures, test results and observations, and reviews data to meet corporate, regulatory and GMP requirements.

The Ideal Candidate

About You

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, Master’s Degree or PhD in a relevant field e.g. Chemistry, Pharmaceutical Sciences

  • Extensive experience in analytical method development and validation (e.g. in HPLC and dissolution)

  • Good knowledge of regulatory requirements, including FDA, EMEA, VICH/ICH regulations

  • Demonstrated project and technical leadership experience

  • Strong verbal and written communication in English

About the Company

About Your Application

All applications received are reviewed by our internal talent acquisition team and we will get in touch if your skills and experience match what we’re looking for. Should you not hear back from us within 28 days please don’t be too disappointed – we may keep your CV on our database for any future vacancies which may be suitable and we encourage you to keep an eye on our careers site. For any questions or queries, please contact us at recruituk@dechra.com

Dechra Pharmaceuticals PLC

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