Manager, Combination Product Development
About The Role
We’re looking for a Manager, Combination Product Development on the Manufacturing, Science and Technology team to help us expand what’s possible for patients with serious diseases. Reporting to the Director, Combination Product Development, you’ll support manufacturing operations by analyzing data and initiating manufacturing investigations, deviations and change controls and developing actions to improve process robustness and product quality related to device development and combination product development.
What You'll Do
In this role, you’ll have the opportunity to generate process, product and life cycle related metrics through statistical analysis. You’ll also:
- Participate in Management Review as related to combination products quality metrics
- Review PQC monthly metrics
- Risk assessment/Analysis/ Risk management file including annual review of UFMEA
- Perform technical assessment to update Design history file for any design or process changes
- Lead complaint trend investigations involving combination product and/or device
- Lead Manufacturing investigations involving combination product and/or device
- Point of contact for the Device manufacturer including organizing regular technical meetings with Device Manufacturer
- Draft NDA amendments for any major changes
- Perform device changes technical assessment and own the change control process for the change
- Perform technical Review of any labeling, IFU and training material changes.
- Representative in CMC meeting responsible to assess device and combination product impact
- Work with cross functional team members effectively
- Experience in GxP systems
Who You Are
You have a bachelor’s degree along with 5 years of experience in engineering/operations. You are or you also have:
- Design Control and Risk Management experience required
- CAPA lifecycle experience, including root cause investigation including Root cause analysis (RCA) techniques required
- Change Control experience required
- Working knowledge of FDA Quality System Regulation, 21 CFR Part 820, ISO 13485:2016, ISO 14971:2007, EU Medical Device Regulation is required
- Must have excellent communication skills (verbal and written)
- Highly organized with a strong attention to detail, clarity, accuracy and conciseness
- Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)
Nice To Have (but not required)
- Certified Quality Engineer or similar preferred
- Statistical expertise preferred (Minitab or other statistical tools experience)
Where You'll Work
This is a hybrid role based out of our Bridgewater, NJ office. You’ll have the option to work remotely most of the time, with in-person collaboration when it matters most.
Travel Requirements
This role requires occasional global travel (approximately 5%–10%).
Pay
$124,000.00 - 161,000.00 Annual
Life at Insmed
At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.
Highlights of our U.S. offerings include:
- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back