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Viatris

Global pharma selling generics and biosimilars

Director, Combination Product Development

Biomedical Engineering & Medical DevicesConfirmed live in the last 24 hours
Full-timeDublin, IrelandIn-person

About the Job

Requirements

  • A degree or higher in Engineering or a relevant scientific discipline, with experience in an R&D or technical environment.
  • Proven experience managing and leading technical teams, ideally within pharmaceutical or combination product development.
  • Strong experience supporting regulatory submissions and leading teams during inspections, such as FDA or notified-body inspections.
  • Working knowledge of relevant quality and design control standards, such as ISO 13485 and FDA 21 CFR Part 820.
  • Ability to convey complex technical information clearly.
  • Demonstrated problem-solving ability and strong organizational skills.
  • Ability to perform effectively in a fast-paced environment.

Responsibilities

  • Lead and manage a multidisciplinary team of scientists and engineers supporting device development for injectable, respiratory, and transdermal combination products.
  • Build, develop, and retain a high-performing team aligned to evolving portfolio and technology needs.
  • Provide technical leadership to ensure generation of robust evidence demonstrating product safety, efficacy, reliability, and regulatory compliance.
  • Serve as the key technical interface between drug product and device teams across combination product development.
  • Oversee critical development activities, including design verification, stability, biological evaluation, extractables, and transport studies.
  • Ensure development and implementation of device control strategies to support manufacturing and successful technology transfer.
  • Support manufacturing process development through technical input, experimental design, and definition of control strategies and specifications.
  • Lead regulatory inspection readiness and represent the team during audits.
  • Ensure all team activities comply with applicable quality standards and the Quality Management System.

About the Company

Viatris

Global pharma selling generics and biosimilars

Viatris is a global pharmaceutical company that provides access to medicines through a diverse portfolio of branded drugs, generics, complex generics, and biosimilars, serving patients in more than 165 countries. Medicines are produced and distributed via Viatris's extensive global supply chain and commercial network, making therapies available across cardiovascular, infectious diseases, immunology, and oncology. The company differentiates itself with a large, diversified product mix, broad international reach, and a focus on access and public health rooted in the Mylan-Upjohn lineage. Its strategy combines organic growth with partnerships and acquisitions to expand patient access while pursuing sustainable operations.

Company size
10,001+
Company stage
IPO
Headquarters
Canonsburg, PA
Founded
1961

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