Manager, Quality Control

Manager, Quality Control

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.

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, 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.

What You'll Do:

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 missionintentionally 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.