Manager, Quality Control Engineering (P)

Insmed Incorporated•San Diego, CA

34d•Onsite

About The Position

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

Requirements

Bachelor’s degree
7+ years of experience in quality control.
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.

Responsibilities

Overseeing and performing the testing of HPLC and compendial methods.
Establishing/qualifying QC test methods.
Authoring/revising SOP’s.
Managing quality events.
Perform and oversee testing of compendial and HPLC, CE-SDS, ICP-MS methods for the product purity group.
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.

Benefits

Comprehensive medical, dental, and vision coverage and mental health support
annual wellbeing reimbursement
access to our Employee Assistance Program (EAP)
Generous paid time off policies
fertility and family-forming benefits
caregiver support
flexible work schedules
401(k) plan with a competitive company match
annual equity awards
participation in our Employee Stock Purchase Plan (ESPP)
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
meaningful opportunities to connect, volunteer, and give back