Manager, Combination Product Development

Location: Hybrid role based out of the Bridgewater, New Jersey office; remote work is available most of the time with in-person collaboration as needed. Occasional global travel of approximately 5%–10% is required.

Salary: $124,000–$161,000 annual.

Company

Global biopharmaceutical company developing treatments for patients with serious and rare diseases.

What you will do

• Analyze process, product, and lifecycle metrics using statistical methods and participate in management reviews of combination product quality metrics.
• Lead complaint trend and manufacturing investigations involving combination products and medical devices.
• Manage risk assessments, risk management files, annual UFMEA reviews, and CAPA-related improvement activities.
• Perform technical assessments for design and process changes, update design history files, and own related change controls.
• Coordinate technical meetings with device manufacturers and assess device and combination product impacts in CMC meetings.
• Draft NDA amendments and review labeling, IFU, and training material changes.

Requirements

• Bachelor’s degree and at least five years of experience in engineering or operations.
• Experience with design control, risk management, CAPA lifecycle activities, root cause analysis, and change control.
• Working knowledge of FDA Quality System Regulation, 21 CFR Part 820, ISO 13485:2016, ISO 14971:2007, and EU Medical Device Regulation.
• Experience working with GxP systems and cross-functional teams.
• Excellent verbal and written communication skills, strong organization, and attention to detail.
• High proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.

Nice to have

• Certified Quality Engineer certification or similar qualification.
• Statistical expertise and experience with Minitab or comparable statistical tools.

Culture & Benefits

• Medical, dental, vision, and mental health support, plus an annual wellbeing reimbursement and Employee Assistance Program.
• Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
• 401(k) plan with company match, annual equity awards, ESPP participation, and company-paid life and disability insurance.
• Learning programs, LinkedIn Learning access, workshops, leadership development, mentorship, and networking opportunities.
• Employee resource groups, service and recognition programs, volunteering, and community engagement opportunities.