Combination Product Manager

Do you have experience in the development of combination products (drug & device)? Would you love the opportunity to work with a privately-owned growing, global generics pharmaceutical company working on a robust pipeline of complex generic products?

Invenia Group has partnered with a global generics company that produces high-quality medicines for those in need. We are now looking to hire a Combination Product Manager and R&D for the company’s fast-growing team. This is a fantastic opportunity to join an international organization with an abundance of successful partnerships around the world.

Role responsibilities:

If successful, you will be responsible for the development of drug-device combination products using design control and risk management processes, as well as the following:

• Design and development of combination products involving the device and drug constituent parts using the design control process
• Monitoring and review of device constituent part development at the third-party design/development house(s) including design reviews and DHF documents review
• Preparation, review, or update of the Design History File (DHF) and risk management file for the combination products
• Subject matter expert for the due diligence of combination products such as injectable pens, inhalation products, transdermal products, infusions, etc
• Partner with Third Party Quality, Combination products to ensure Design History Files and Risk Management Files are complete and compliant
• Support complaint management, pharmacovigilance, and operations to assess product risks and risk reviews

What we are looking for:

We are looking for someone with a BS/MS in Engineering (Mechanical or Chemical) or equivalent with a minimum of 5 years of industry experience in the development of combination products (drug & device). You should have experience in developing combination products using design controls including product risk management.

Sound interesting? To find out more information regarding this exciting opportunity, please apply.