Director, Combination Product Development

About Viatris and the Global Device Development Team

McDermott Laboratories Limited operates as a part of Viatris, a global healthcare organization dedicated to bridging generics and branded medicines. Viatris aims to empower individuals worldwide to maintain healthier lives through all life stages by supplying high-quality medicines to around 1 billion patients annually. Their extensive portfolio ranges from iconic brand-name products to generics, branded, complex generics, across various therapeutic areas. Viatris promotes creating healthier communities through education, outreach, and improved treatment access.

The Global Device Development department at Viatris is a dynamic, expert-driven, and fully integrated unit committed to delivering safe, effective, and superior device and combination products that meet patients' evolving healthcare requirements worldwide. They innovate advanced drug delivery technologies spanning respiratory, transdermal, biologic, biosimilar, and injectable therapies and collaborate across Viatris to improve patient outcomes. Their operations are spread across Dublin, Cambridge, Sandwich, and Southpointe.

Role Overview and Key Responsibilities

• Direct and manage a cross-functional team of engineers and scientists working on device development for injectable, respiratory, and transdermal combination products.
• Develop, nurture, and retain a high-performing team aligned with ongoing portfolio and technological developments.
• Lead the technical aspects ensuring robust evidence supports product safety, effectiveness, reliability, and regulatory compliance.
• Act as the primary technical liaison between drug product and device teams within combination product development.
• Supervise essential development tasks such as design verification, stability assessments, biological evaluations, extractables testing, and transportation studies.
• Establish and implement device control strategies to facilitate manufacturing and successful technology transfer.
• Provide technical guidance in manufacturing process development, including experimental design and definition of control strategies and specifications.
• Coordinate readiness for regulatory inspections and represent the team during audits.
• Ensure all operations comply with applicable quality standards and the organization's Quality Management System.

Candidate Profile and Qualifications

• Academic qualifications including a degree or higher in Engineering or related scientific fields with experience in R&D or technical roles.
• Demonstrated experience in managing and leading technical teams, preferably within pharmaceutical or combination product development contexts.
• Extensive background in supporting regulatory submissions and leading inspection teams for authorities such as FDA or notified bodies.
• Familiarity with pertinent quality and design control standards including ISO 13485 and FDA 21 CFR Part 820.
• Outstanding communication, leadership, and stakeholder engagement capabilities, capable of articulating complex technical subjects clearly.
• Strong analytical problem-solving, organizational acumen, and adaptability to fast-paced environments.

Commitment to Diversity and Inclusion

Viatris promotes a diverse, inclusive, and authentic workplace culture. Candidates whose experiences do not match every requirement are still encouraged to apply as they may be suitable for this or other roles.

Benefits and Work Environment

• Competitive salary packages.
• Opportunities for career advancement.
• Initiatives that support work-life balance.
• Bonus schemes.
• Health insurance coverage.
• Retirement pension plans.

Sustainability and Corporate Responsibility

Viatris integrates corporate social responsibility into its mission, promoting sustainable and responsible operations and striving to empower global populations to live healthier lives.

Equal Opportunity Employer

Viatris is an Equal Opportunity Employer committed to fostering a diverse and inclusive workforce.