Director - 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 Director, CMC – Biopharmaceuticals is a senior leader within Product Development, responsible for building and leading a high-performing biopharmaceutical CMC organization that consistently delivers high-quality products, data, and regulatory outcomes.

The role provides scientific, strategic, and people leadership for all assigned Chemistry, Manufacturing, and Controls (CMC) activities supporting biopharmaceutical (large-molecule) development programs, from early development through registration and commercialization. The Director sets direction, creates clarity, and drives execution through others, ensuring that teams are motivated, accountable, and aligned to shared objectives.

Biopharmaceutical CMC development and manufacturing activities are predominantly executed through external partners. The Director leads with confidence and urgency, creating a culture of ownership, transparency, and results, while ensuring delivery of robust drug substance and drug product designs, manufacturing processes, and complete CMC data packages to support development, registration, and commercialization.

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

Biopharmaceutical CMC Leadership

Set a clear scientific and strategic direction for biopharmaceutical CMC activities and translate that direction into executable plans and priorities.
Build a strong leadership culture within the biopharmaceutical CMC team, characterized by accountability, collaboration, and delivery focus.
Coach, empower, and hold accountable Biopharmaceutical CMC Leads and Project Leads to take ownership, make decisions, and drive outcomes.
Act as the senior functional CMC leader and escalation point for biopharmaceutical programs, providing clarity and direction when programs encounter complexity or uncertainty.
Ensure CMC activities are fully integrated with clinical, safety, regulatory, and commercialization workstreams and contribute meaningfully to overall project success.
Ensure CMC strategies and deliverables align with the Co-Development (CoDev) framework and associated governance processes, and that CMC-related changes with potential commercial impact are identified and managed appropriately.

Portfolio and Project Oversight

Maintain end-to-end oversight of CMC aspects for assigned biopharmaceutical programs, with clear visibility of status, risks, dependencies, and resource utilization.
Ensure CMC execution plans align with agreed project timelines, budgets, and clinical and regulatory pathways.
Support portfolio-level planning and prioritization discussions within Product Development.
When required, personally act as Project Lead or CMC Lead for programs of elevated complexity or strategic importance.

Scientific and Technical Leadership

Provide senior scientific judgment and guidance to support resolution of complex technical, regulatory, or manufacturing challenges within biopharmaceutical programs.
Support CMC Leads and project teams in unblocking stalled or high-risk programs and driving technically sound, pragmatic decisions.
Ensure high scientific rigor and regulatory readiness across all assigned programs, in compliance with GxP, Dechra quality standards, and global regulatory requirements.
Maintain awareness of emerging technologies, regulatory expectations, and industry best practices relevant to biopharmaceutical CMC and ensure appropriate application within Product Development.

Platform, Capability, and External Partner Development

Shape the evolution of biopharmaceutical CMC platforms, standards, and operating models to support both current delivery and future pipeline growth.
Lead the selection, qualification, governance, and ongoing performance management of CMOs and specialist laboratories supporting biopharmaceutical programs.
Drive continuous improvement in CMC approaches to enhance robustness, scalability, reliability, and cost-effectiveness of biopharmaceutical products.
Contribute to the long-term development of biopharmaceutical CMC capability within Product Development.

Cross-Functional and External Collaboration

Work closely with Regulatory Affairs to support CMC sections of regulatory submissions and interactions with regulatory authorities.
Collaborate with MS&T, Manufacturing, and Quality to ensure effective technology transfer and alignment with commercial manufacturing requirements.
Partner with the Global Marketing and Technical Excellence (GMTE) organization within the Commercial function to ensure alignment between CMC strategy, target product profiles, and commercial objectives.
Partner effectively with Efficacy, Safety, and other DRD functions to ensure integrated development planning and delivery.
Support due diligence and evaluation of External Innovation opportunities involving biopharmaceutical products, as required.
Key Performance Indicators
- Delivery of biopharmaceutical CMC components to agreed timelines, budgets, and regulatory quality standards.
- Readiness of biopharmaceutical CMC strategies to support registration and commercialization milestones.
- Early identification, transparent communication, and effective mitigation of CMC-related technical and regulatory risks.
- Quality, consistency, and integration of CMC contributions across biopharmaceutical programs.
- Performance, reliability, and effectiveness of external partners supporting development and manufacturing.

Technical & Scientific Leadership

Deep understanding of biopharmaceutical CMC, including drug substance manufacture, drug product development, analytical strategies, and control strategies.
Ability to apply scientific judgment to complex, ambiguous technical and regulatory challenges.

Decision-Making & Judgment

Makes balanced, risk-based decisions considering scientific, regulatory, commercial, and operational factors.
Anticipates issues, evaluates plausible scenarios, and escalates early with clear analysis and recommendations using a structured what / so what / now what and scenario-based approach.

Leadership, Team Culture & Influence

Creates and leads a highly effective, motivated, and engaged biopharmaceutical CMC team that takes pride in delivery and quality.
Sets a strong leadership tone, demonstrating urgency, ownership, and accountability while fostering trust and collaboration.
Inspires confidence across project teams and functions through clarity of direction, consistency of decisions, and visible leadership presence.
Represents biopharmaceutical CMC with credibility and authority in interactions with senior internal stakeholders and external partners.

Leadership & Capability Development

Actively develops CMC Leads and scientists through coaching, feedback, and stretch opportunities.
Builds a resilient organization with strong bench strength, clear succession, and sustainable ways of working.
Establishes clear expectations for performance, behaviors, and decision-making, and holds individuals accountable in a fair and transparent way.
Champions a culture of continuous improvement, learning, and professional excellence.
long-term biopharmaceutical CMC capability across Product Development.

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:

10+ years’ experience in large-molecule / biopharmaceutical CMC (e.g. biologics, vaccines, peptides, proteins, or similar modalities).
Demonstrated experience supporting CMC development from early development through registration and commercialization.
Experience working with global regulatory agencies (FDA, EMA, and/or other major authorities).
Proven ability to build, motivate, and lead high-performing teams, creating energy, accountability, and a strong sense of ownership while delivering through a matrixed organization.

Desirable

Experience supporting technology transfer and commercial manufacturing readiness.
Exposure to veterinary pharmaceuticals or regulated animal-health products.

Qualifications

PhD, MSc, or equivalent advanced degree in Chemistry, Biochemistry, Bioprocess Engineering, Pharmaceutical Sciences, or a related discipline.

Travel

Ability and willingness to travel nationally and internationally as required.

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.

Apply