Combination Product Manager, R&D

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Regular Full-Time Pinebrook, NJ, US

Salary Range: $ To $ Annually

SUMMARY OF POSITION

The Combination Product Manager, R&D, is responsible for the development of drug-device combination products using design control and risk management processes. This position will also participate in review of device development, due-diligence of new combination products and investigation of market complaints.

ORGANIZATION STRUCTURE

The Combination Product Manager reports to the Executive Director, External R&D. The role interfaces with cross-functional departments including Quality, Regulatory Affairs, Clinical, Pharmacovigilance, Project Management, and Supply Chain as well as cross-companies such as third‑party design centers, CMOs, and device component suppliers.

RESPONSIBILITIES

Primary responsibilities of this role include the following:

• Design and development of combination products involving device and drug constituent parts using the design control process (in compliance with 21
  
  CFR
  820.30 and ISO
  13485:2016 section 7.3).
• Preparation, review or update of Design History File (DHF) and risk management file (in compliance with ISO 14971:2019) for the combination products
• Monitoring and review of device constituent part development at the third party design/development house(s) including design reviews and DHF documents review
• Subject matter expert for the due diligence of combination products such as injectable pens, inhalation products, transdermal products, infusions, etc.
• Contribute to the update of commercial combination product design and/or risk files, as needed.
• Partner with Third Party Quality, Combination product 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.
• Keep abreast of regulatory, cGMP and QSR trends. Stay informed of FDA, EU and ICH Guidelines on drug-device combination products.

QUALIFICATIONS

• BS/MS in Engineering (Mechanical or Chemical) or equivalent with 5-7 years of industry experience in the development of combination products (drug & device).
• Two to three years of experience with the development of generic combination products is preferable
• Experience in the preparation, review and/or update of DHF for combination products is desirable.
• Previous work experience should involve developing combination products using design controls including product risk management.
• Strong written and verbal communication skills, specifically in technical writing and oral presentations.
• Capable of working independently based on regulatory requirements, and company goals.

The anticipated base salary range for this position is $130,000-$140,000 . This position is eligible for Alvogen’s annual discretionary bonus and comprehensive benefits package,

• consisting of medical and prescription drug coverage (two PPO plans and an HDHP with Health Savings Account and employer contribution), dental, vision, flexible spending accounts.
• retirement savings program, long‑term care coverage, paid time off (176 hours per year, prorated to hire date ) inclusive of sick time, disability benefits, life insurance, a wellness program, and 13 company recognized paid holidays per year.

We anticipate this position will be posted on February 17, 2026 and remain open for at least 30 days.