Manager, Combination Product Development

Insmed Incorporated•NJ Corporate Headquarters, NJ

40d•$124,000 - $161,000•Hybrid

About The Position

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.

Requirements

Bachelor’s degree along with 5 years of experience in engineering/operations.
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.
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 Haves

Certified Quality Engineer or similar preferred.
Statistical expertise preferred (Minitab or other statistical tools experience).

Responsibilities

Generate process, product and life cycle related metrics through statistical analysis.
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.

Benefits

Comprehensive medical, dental, and vision coverage and mental health support
Annual wellbeing reimbursement
Access to our Employee Assistance Program (EAP)
Generous paid time off policies
Fertility and family-forming benefits
Caregiver support
Flexible work schedules with purposeful in-person collaboration
401(k) plan with a competitive company match
Annual equity awards
Participation in our Employee Stock Purchase Plan (ESPP)
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
Meaningful opportunities to connect, volunteer, and give back