Job Introduction
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)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.expertise and leadership in the selection, interpretation of data, and validation of analytical methods for

• 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.
• Accountable for all analytical development, validation and transfer activities from preclinical development through clinical supplies for registrations 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 goal.
• 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 of product development projects. Activities can be performed either at an internal pharmaceutical development laboratory and manufacturing site or at a contract manufacturing organization.
• Keep abreast of advances and technologies in the field and applies these technologies to support the development project.
• Collaborate with Procurement, DPM and/or DPM to provide COGs estimates
• Responsible for creation, oversight and execution of the CMC project plan. Ensure CMC project deliverables meet the program needs, timelines and cost constraints and are aligned to the overall regulatory and development strategy.
• Communicate resource requirements for product development within project teams so that scope, timeline and budgets can be assembled accordingly.
• Keep stakeholders and project lead informed of progress, issues, risk, key decisions and spend.
• Leverage technical expertise and consider the evolving regulatory landscape to navigate the development process.
• Assess the viability of the proposed manufacturing processes and analytical
• technology identifying shortfalls and/or problem areas. Defines mitigation and/or contingency plans, executing scenario planning and risk assessments.
• Author and/or provides critical review of technical protocols, product development reports, batch records and CMC sections for regulatory filling. Including preparing and/or critical review of responses to deficiencies and CLOQs.
• Establish and maintain necessary collaborations with external partners, such as CROs, CDMOs, IP licence holders, patent advisors and scientific experts in the field.
• Provide technical support to DPM and Technical Services during product handover and launch