(Senior) Principal Scientist, CMC - Biopharmaceuticals

Vacancies

(Senior) Principal Scientist, CMC - Biopharmaceuticals

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.

The Opportunity

The (Senior) Principal Scientist, CMC - Biopharmaceuticals is responsible for the technical leadership and delivery of Chemistry, Manufacturing, and Controls (CMC) activities for assigned biopharmaceutical (large-molecule) development programs within Product Development.

The role acts as CMC Lead for assigned biopharmaceutical programs and may also serve as Project Lead for selected programs, accountable for planning, execution, and delivery of CMC activities from early development through registration and commercial readiness.

Biopharmaceutical CMC activities are predominantly executed through external partners and require strong technical oversight, active partner management, and disciplined cross-functional collaboration to ensure timely and high-quality delivery of robust manufacturing processes and regulatory-ready data packages.

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

• Act as CMC Lead for assigned development programs, accountable for delivery of drug substance and drug product activities from early development through clinical supply, registration, and commercial readiness.
• Lead development of drug substance (e.g., cell line development and process development), drug product formulation, analytical methods, process development, comparability, and control strategies.
• Develop and maintain detailed, actionable CMC plans aligned with overall project timelines, budgets, regulatory strategy, and Co-Development (CoDev) principles.
• Drive execution of CMC activities with clear prioritization, ensuring delivery against timelines and agreed milestones.
• Identify, assess, and actively manage technical, regulatory, and manufacturing risks, ensuring early visibility, structured evaluation, and timely mitigation.
• Author and/or support preparation of CMC regulatory documentation in collaboration with Regulatory Affairs.
• Support regulatory agency interactions as required in collaboration with Regulatory Affairs.
• Support intellectual property (IP) and patent strategies in collaboration with relevant internal stakeholders.
• Collaborate proactively with Regulatory Affairs, Quality, Manufacturing, MS&T, Efficacy, Safety, and GMTE to ensure integrated development and alignment with clinical and commercial objectives.

External Partner Management

• Serve as the primary technical interface to CDMOs and contract laboratories supporting assigned programs.
• Set clear expectations for scope, timelines, quality, and deliverables, ensuring alignment at initiation and throughout execution.
• Actively manage partner performance through regular engagement, ensuring progress, resolving issues, and maintaining delivery timelines.
• Identify emerging issues early and drive timely escalation and resolution within both partner organizations and internal project teams.

Cross-Functional Collaboration

• Work closely with Regulatory Affairs, Safety, Efficacy, Quality, MS&T, Manufacturing, and GMTE to ensure integrated development across functions.
• Ensure that CMC strategies, control strategies, manufacturability, and development approaches are aligned across functions and support overall project objectives.
• Communicate risks, trade-offs, and decisions clearly to enable timely and informed decision-making within project teams.
• Support technology transfer activities and preparation for commercial manufacturing.

Project Leadership (when required)

• When assigned, act as Project Lead, accountable for integrated project planning, execution, reporting, and delivery in close collaboration with Project Management.
• Act as project representative to governance bodies, ensuring transparent communication of development strategies, scenarios, risks, and resource requirements.
• Lead project team meetings with clear structure and outcomes, ensuring actions are defined, tracked, and delivered.
• Drive timely decision-making and issue resolution, maintaining project momentum and ensuring alignment across functions.

Grade Differentiation

Principal Scientist

• Delivers CMC activities for assigned programs within defined scope and established frameworks.
• Applies established scientific, technical, and regulatory principles effectively.
• Makes sound technical decisions within own domain and escalates complex or high-risk issues appropriately.
• Drives execution within defined project scope, ensuring clarity of tasks and timely delivery.

Senior Principal Scientist

• Leads complex, high-risk, or high-visibility programs with increased autonomy.
• Anticipates technical and regulatory risks and drives mitigation proactively.
• Applies structured thinking to evaluate scenarios and guide decision-making in ambiguous situations.
• Acts as a technical reference point and mentor for other CMC scientists.
• Drives alignment and execution across multiple functions and stakeholders, ensuring progress in complex or evolving situations.
• (Note: Project leadership is not a requirement for Senior Principal Scientist designation and may be performed at either level depending on program needs and individual capability.)

Competencies

Technical & Scientific

• • Principal Scientist: Strong technical foundation in biopharmaceutical CMC.
  • Senior Principal Scientist: Recognized technical authority in biopharmaceutical CMC; applies scientific judgment to complex and ambiguous development and manufacturing challenges.

Decision-Making & Judgment

• Principal Scientist: Makes sound technical decisions within defined scope, identifies emerging issues early, and escalates risks appropriately using a structured what / so what / now what and scenario-based approach.
• Senior Principal Scientist: Anticipates complex or ambiguous risks, evaluates trade-offs, and escalates issues with clear analysis and recommendations using a structured what / so what / now what and scenario-based approach.

Collaboration & Influence

• Principal Scientist: Works effectively within matrixed project teams and with external partners; communicates clearly and supports alignment across stakeholders.
• Senior Principal Scientist: Influences across functions and with senior internal and external stakeholders through technical credibility, clarity of communication, and ability to drive alignment and progress.

Leadership & Capability Development

• Principal Scientist: Focused on reliable delivery, ownership of assigned work, and informal mentoring of colleagues.
• Senior Principal Scientist: Actively mentors others, supports development of team capability, and contributes to establishing effective and scalable ways of working within Global CMC.

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:

• MSc or PhD in Biochemistry, Bioprocess Engineering, Pharmaceutical Sciences, or related discipline
• 5-10+ years experience in biopharmaceutical / large-molecule CMC development
• Strong knowledge of biopharmaceutical CMC, including:
• Cell line development
• Process development
• Drug product formulation
• Analytical development and control strategies
• Experience working with external CDMOs and contract laboratories
• Working knowledge of global regulatory requirements (FDA, EMA, VICH/ICH, and USDA where applicable)
• Global travel will be required (approx 20%-30%)

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.