Description

At Insmed, every moment and every patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we're in. Are you?

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%)

#LI-BA

#LI-HYBRID

Pay Range:
$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

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

Current Insmed Employees: Please apply via the Jobs Hub in Workday.

Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at [email protected] and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Applications are accepted for 5 calendar days from the date posted or until the position is filled.

For New York City Residents:

To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool ("AEDT") that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. The AEDT does not make final hiring decisions and all final hiring decisions are subject to human oversight and/or review.

If you are an applicant for this role and a New York City resident, you have the right to request:

• A reasonable accommodation, if one is available under applicable law, by emailing [email protected]; and/or
• An alternative selection process by emailing [email protected].
• Information about the type of data collected, the source of that data, and data retention practices related to the AEDT by emailing us at [email protected].