Director, Combination Product Development

at  Viatris

McDermott Laboratories Limited
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
Our Global Device Development is an innovative, technically excellent and fully integrated organization, delivering access to high quality, safe, robust and effective device and combination products to meet the worlds’ evolving patient healthcare needs. We develop device technologies to enable drug-delivery for respiratory, biologic, biosimilar and injectable products, and work across Viatris to support innovative technology solutions to provide healthcare solutions for our patients. We operate from 4 sites: Dublin, Ireland, Cambridge & Sandwich, UK and Southpointe, Pittsburgh, USA. Every member of our team is dedicated to creating better health for a better world, one person at a time.
Every day, we rise to the challenge to make a difference and here’s how the Director, Combination Product Development - Injectables, Respiratory and Transdermal (Global Device Development) a people manager role will make an impact:

Key responsibilities for this role include:

• People manager of Scientists and Engineers who support device development for Injectables, Respiratory and Transdermal combination products
• Build and expand team with responsibility for hiring new positions to support new technologies and programs within the Injectables, Respiratory and Transdermal portfolio.
• Lead a team who support device development by generating the critical evidence that demonstrates to regulatory agencies that the combination product is safe, effective, reliable and fulfills regulatory requirements.
• Responsible for technical interface between drug product and device teams during combination product development on elements such as primary container interface and compatibility, exhibit batch manufacture and stability studies
• Lead and provide technical oversight to a team responsible for design verification, stability, biological evaluation, extractables, and transport & shipping studies.
• Responsible for leading a technical team during regulatory and notified body inspections by representing the team in front of auditors and ensuring audit readiness.
• Overall responsible for method development, approval of method validations and test protocols and reports.
• Technical oversight of team responsible for the development of design requirements and combination product specifications based on characterization of comparator products, regulatory requirements, design intent and user requirements.
• Provide technical support to manufacturing sites during filling and assembly process development. Responsible for designing experiments and manufacturing trials to identify process controls, reliability requirements, sampling plans and release specifications.
• Responsible for ensuring a device control strategy is in place to support combination product manufacture and transfer to manufacturing site.
• Trending and statistical analysis of design verification and manufacturing data including compilation of technical reports to support combination product development lifecycle.
• Ensures all activities within team are conducted and executed to the appropriate quality standards within the GDD Quality Management System.

The minimum qualifications for this role are:

• The ideal candidate will be a qualified, highly experienced pharmaceutical professional with a proven track record of success, a positive attitude and who wants to progress in a fast-paced environment.
• Experienced People Manager.
• Masters/Degree in Engineering/Science with experience in R&D or Technical Support environment.
• Previous experience of managing a technical team in an R&D environment.
• Experienced in writing regulatory submissions.
• Experienced in leading a technical team in support of FDA, HPRA or notified body inspections
• A working knowledge of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements would be an advantage.
• It is essential that the candidate will be both highly innovative and well organized, having excellent planning and communication skills and able to operate across all site teams. In addition, the candidate must be able to work under pressure and have a proven track record of problem solving and effective time management.
• Well-developed communication skills to lead or facilitate effective discussions. Able to communicate technical information to key stakeholders.
• Some travel will be required as part of this role.

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.
Benefits at Viatris

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Some of our benefits include the following on top of a competitive salary:

• Excellent career progression opportunities
• Work-life balance initiatives
• Bonus scheme
• Health insurance
• Pension

Diversity & Inclusion at Viatris
At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit
https://www.viatris.com/en/Careers/Diversity-and-Inclusion
Sustainability at Viatris
Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit
https://www.viatris.com/en/about-us/corporate-responsibility
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer.

Key responsibilities for this role include:

• People manager of Scientists and Engineers who support device development for Injectables, Respiratory and Transdermal combination products
• Build and expand team with responsibility for hiring new positions to support new technologies and programs within the Injectables, Respiratory and Transdermal portfolio.
• Lead a team who support device development by generating the critical evidence that demonstrates to regulatory agencies that the combination product is safe, effective, reliable and fulfills regulatory requirements.
• Responsible for technical interface between drug product and device teams during combination product development on elements such as primary container interface and compatibility, exhibit batch manufacture and stability studies
• Lead and provide technical oversight to a team responsible for design verification, stability, biological evaluation, extractables, and transport & shipping studies.
• Responsible for leading a technical team during regulatory and notified body inspections by representing the team in front of auditors and ensuring audit readiness.
• Overall responsible for method development, approval of method validations and test protocols and reports.
• Technical oversight of team responsible for the development of design requirements and combination product specifications based on characterization of comparator products, regulatory requirements, design intent and user requirements.
• Provide technical support to manufacturing sites during filling and assembly process development. Responsible for designing experiments and manufacturing trials to identify process controls, reliability requirements, sampling plans and release specifications.
• Responsible for ensuring a device control strategy is in place to support combination product manufacture and transfer to manufacturing site.
• Trending and statistical analysis of design verification and manufacturing data including compilation of technical reports to support combination product development lifecycle.
• Ensures all activities within team are conducted and executed to the appropriate quality standards within the GDD Quality Management System

The minimum qualifications for this role are:

• The ideal candidate will be a qualified, highly experienced pharmaceutical professional with a proven track record of success, a positive attitude and who wants to progress in a fast-paced environment.
• Experienced People Manager.
• Masters/Degree in Engineering/Science with experience in R&D or Technical Support environment.
• Previous experience of managing a technical team in an R&D environment.
• Experienced in writing regulatory submissions.
• Experienced in leading a technical team in support of FDA, HPRA or notified body inspections
• A working knowledge of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements would be an advantage.
• It is essential that the candidate will be both highly innovative and well organized, having excellent planning and communication skills and able to operate across all site teams. In addition, the candidate must be able to work under pressure and have a proven track record of problem solving and effective time management.
• Well-developed communication skills to lead or facilitate effective discussions. Able to communicate technical information to key stakeholders.
• Some travel will be required as part of this role