Specialist, Quality CMC Operations at Insmed · NJ…

Specialist, Quality CMC Operations

Location: NJ Corporate Headquarters · Hybrid

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:

Reporting to the Sr. Director, Quality CMC, the Quality Specialist will play a key role in executing QA activities for Insmed supporting Phase 1- 3 pipeline products. Specific areas of responsibility include Batch Record Review, Product Release process, CoA review, CoR generation, QA Metric monitoring, in addition to other QA related activities.

What You'll Do:

In this role, you’ll have the opportunity to perform batch disposition activities, including reviewing and approving batch records, certificates of analysis, and other relevant documentation for pipeline drug substance, drug product and medical devices.

You’ll also:

• Generate certificate of releases, create lots in electronic system and upload all required documents for internal and external stakeholders.
• Ensure compliance with all relevant regulations and guidelines related to pharmaceutical quality and batch disposition.
• Collaborate with cross-functional teams to resolve quality-related issues and ensure timely release of products.
• Drive continuous improvement initiatives to enhance the efficiency and effectiveness of quality assurance and batch disposition processes.
• Develop and maintain standard operating procedures (SOPs) for batch disposition and quality assurance processes.
• Communicate with external suppliers and internal stakeholders regarding quality-related matters.
• Maintain accurate and organized records of all quality assurance and batch disposition activities.
• Participate in cross-functional projects and provide quality assurance expertise and support, as needed.
• Partner with Quality CMC team members and colleagues in other departments to increase the overall effectiveness of the Quality Assurance department and build supportive, productive relationships.

Who You Are:

You have a minimum of a Bachelor's degree in Chemistry, Life Science or related discipline as well as at least 3 years’ experience working in a pharmaceutical company. You are or also have:

• Familiarity of pharmaceutical product manufacturing processes, medical devices, and analytical laboratory practices.
• Demontrated experience working with an electronic document management system.
• Must be knowledgeable on cGMP's and other regulatory requirements applicable to GMP product manufacturing operation and release.
• Proven experience in batch records review and product release process
• Demonstrate ability to manage projects and variable workloads.
• 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).
• Knowledge of Veeva Quality Vault system is highly desirable.

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 domestic/international travel (approximately up to 10%).

#LI-hybrid

#LI-EG1

Pay Range:

$39.00-50.00 Hourly

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. For more information, please refer to our Equal Employment Opportunity and Non-Discrimination Statement on our Careers site.

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 TotalRewards@insmed.com 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.