Combination Product Manager, R&D

Alvogen; New Jersey; On-site; USD 130,000 - 140,000; Full time

Benefits offered by this job

Annual bonus

Medical & prescription coverage

Dental & Vision

HSA/HDHP

Retirement program

PTO 176 hours

Disability benefits

Life insurance

Wellness program

Paid holidays

Job summary

Alvogen is seeking a Combination Product Manager, R&D, in New Jersey. The role leads design controls for drug-device combinations, reviews DHF and risk management files, and performs due diligence on new products.

The candidate will liaise with QA, Regulatory, Clinical, PV, and Supply Chain while overseeing third-party design centers and CMOs. A strong cross-functional communicator with 5–7 years of relevant experience is required.

Qualifications

• BS/MS in Engineering (Mechanical or Chemical) or equivalent.
• 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 preparing, reviewing and updating Design History Files (DHF) for combination products.

Responsibilities

• Design and develop combination products using design control.
• Prepare, review or update Design History File (DHF) and risk management file (ISO 14971:2019).
• Monitor third party design/development and review DHF documents.
• Serve as SME for due diligence of combination products (injectable pens, inhalation products, transdermal products, infusions).
• Contribute to updating commercial design and risk files as needed.
• Partner with Third Party Quality to ensure DHF and Risk Management Files are complete and compliant.
• Support complaint management and pharmacovigilance to assess product risks.
• Stay informed on FDA, EU and ICH guidelines on drug-device combinations.

Skills

Design controls

Risk management

Technical writing

Oral presentations

Independent work

Regulatory awareness

Education

Engineering degree (Mechanical or Chemical)

Job description

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:

1. 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).
2. Preparation, review or update of Design History File (DHF) and risk management file (in compliance with ISO 14971:2019) for the combination products
3. Monitoring and review of device constituent part development at the third party design/development house(s) including design reviews and DHF documents review
4. Subject matter expert for the due diligence of combination products such as injectable pens, inhalation products, transdermal products, infusions, etc.
5. Contribute to the update of commercial combination product design and/or risk files, as needed.
6. Partner with Third Party Quality, Combination product to ensure Design History Files and Risk Management Files are complete and compliant
7. Support complaint management, pharmacovigilance, and operations to assess product risks and risk reviews.
8. Keep abreast of regulatory, cGMP and QSR trends. Stay informed of FDA, EU and ICH Guidelines on drug-device combination products.

QUALIFICATIONS

1. BS/MS in Engineering (Mechanical or Chemical) or equivalent with 5-7 years of industry experience in the development of combination products (drug & device).
2. Two to three years of experience with the development of generic combination products is preferable
3. Experience in the preparation, review and/or update of DHF for combination products is desirable.
4. Previous work experience should involve developing combination products using design controls including product risk management.
5. Strong written and verbal communication skills, specifically in technical writing and oral presentations.
6. 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. Alvogen's benefits package also includes a 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.

"An Equal Opportunity Employer, including disability/vets."