Senior Principal Scientist - Analytical

Vacancies

Senior Principal Scientist - Analytical

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

The Opportunity

The Senior Principal Scientist, Analytical, will be part of teams which ensure the timely development of products that meet the standards of relevant regulatory authorities to support animal drug applications for a broad range of dosage types.

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

Role Responsibility

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

• 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.
  • Proactivelyconsiders and directs next steps in analytical method development in orderto 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 inthe field.
  • Provide technical support to DPM and Technical Services during product handover and launch.

The 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 excited to hear from those who have/are:

• Bachelor's, Master's Degree, or PhD in a relevant field e.g. Chemistry, Pharmaceutical Sciences, Biotechnology, Protein Chemistry
• Pharmaceutical (product development) experience with increasing level of (project) leadership responsibility.
• Proven track record in developing and transferring analytical assays to manufacturing for biopharmaceutical products
• Working knowledge of biopharmaceutical products including antibodies, proteins and fusion molecules
• Understanding of method validation, stability testing, process validation, quality assurance
• Strong organisational and problem solving experience
• In depth knowledge of regulatory requirements, including FDA, EMA, USDA, VICH/ICH regulations
• Demonstrated technical leadership experience

Additional Information:

• Occasional travel may be required (domestic and international)

Abbreviations:

CMC: Chemistry, Manufacturing and Control

DPM: Dechra Pharmaceuticals Manufacturing

GxP: Good manufacturing practices (GMP), Good laboratory practices (GLP), Good clinical practices (GCP)

COGs: Cost of Goods

CLOQs: Consolidated Lists of Questions

EH&S: Environmental, Health and Safety

About the Company

As a people first values-based culture, we provide free weekly wellness sessions focused on our employee's physical and mental wellbeing, and flexible work arrangements. We offer a generous employer 401k match and an other incentives for long-term financial wellness. Our full array of health, financial and voluntary benefit programs are what you would expect from a recognized Best Place to Work.