Manager, Quality Control Engineering (P)

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:

What You'll Do:

We’re looking for a Manager, Quality Control on the Quality Control team to help us expand what’s possible for patients with serious diseases. Reporting to the Associate Director, Quality Control, you’ll be responsible for overseeing and performing the testing of HPLC and compendial methods. Additional responsibilities include, but are not limited to, establishing/qualifying QC test methods, authoring/revising SOP’s, and managing quality events.

Who You Are:

In this role, you’ll have the opportunity to perform and oversee testing of compendial and HPLC, CE-SDS, ICP-MS methods for the product purity group You’ll also:

• Ensure the timely execution of all routine QC testing, data review/trending, and preparation of summary reports.
• Perform and oversee quality events such as deviation, CAPA, change control, investigation of OOS, OOT and atypical results within the company QMS according to established procedures.

• Author, review, and approve QC analytical SOPs, protocols, and reports
• Function as SME for HPLC, CE-SDS, pH, Osmolality, appearance, ICP-MS and DLS.
• Develop timelines and protocols for assay transfers, qualifications and validations. Support method transfer activities between lab and CDMO’s.
• Manage QC laboratory, track critical reagents and logbooks, and ensure all the equipment is calibrated
• Utilize software to perform routine laboratory activities (Labware LIMS, JMP, Chromeleon, etc.). Participate in implementation of new software and updates as a subject matter expert.
• Establish laboratory and participate in hiring and training of QC staff

Who You Are:

You have a Bachelor’s degree along with 7+ years of experience in quality control.

You are or you also have:

• Experiences in a gene therapy company with a GMP testing focus, ideally covering the analytical method and testing lifecycle from development through commercial drug product testing, with experience in a GMP QC release testing role
• Experiences in developing methods with particular emphasis on HPLC assays, elemental analysis by ICP-MS, protein purity by CE-SDS, and compendial methods.
• Significant experience in an FDA-regulated environment
• Excellent organizational and communication skills
• Experience with direct reports or managing people

Where You’ll Work

This role is based out of our San Diego, CA office and requires full-time, in-person presence to support hands-on collaboration, access specialized equipment, and/or operational needs.

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 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.

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 TotalRewards@insmed.com; and/or

• An alternative selection process by emailing Privacy@insmed.com.

• Information about the type of data collected, the source of that data, and data retention practices related to the AEDT by emailing us at Privacy@insmed.com.