Senior Principal Scientist - Analytical

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:

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 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 goals.

As an Analytical lead:

• 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.
• Keep abreast of advances and technologies in the field and applies these technologies to support the development project.
• 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 analytical strategy and methods, identifying shortfalls and/or problem areas. Defines mitigation and/or contingency plans, executing scenario planning and risk assessments.
• Authors 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.

As a project lead (when assigned):

• Accountable for the overall planning, reporting, and execution of the project, engaging and working closely with the project team to provide clear direction. 
• Lead the project team to successful registration and launch of the product. Consistently achieve project goals with the project team
• Ensure coordination and alignment of CMC activities with the other project work streams (clinical, safety, efficacy, labelling) and functional groups.
• Energize, inspire and lead team members to maximize the potential of both of the group and of the individuals within, understanding individual ‘s need and providing specific and differentiated support to ensure best outcome for the project and the team. 
• Ensure the project team executes and completes the project and that the project is delivered within the approved budget, schedule and scope.
• Take decisions, consult with key stakeholders and escalate issues that cannot be resolved in the team.
• Prepare, design and implement the research and development plan, including tasks, status reports, timing and cost of project activities. 
• Responsible for regular updates to the Senior Executive Team on timelines, costs and risks of the project, working closely with Project Management.
• Interaction with Regulatory Agencies (eg. FDA, EMA), working closely with Regulatory Affairs.

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.