Manager, Quality Control Bioassay

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, Quality Control - Bioassay 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 participate in the transfer, qualification, and optimization of methods in a Quality Control environment throughout the lifecycle of the method. This individual shall also be able to author/implement Quality Control area procedures for an AAV based gene therapy laboratory.What You'll Do: In this role, you’ll have the opportunity to provide oversight of cell-based biological potency assays, protein chemistry assays, and molecular biology assays for process monitoring, stability, and release in a GMP environment such as SDS-PAGE, western blot, ddPCR or qPCR, and culture of primary mammalian cells. You’ll also:Actively participate and manage in the timely execution of all routine QC testing, data review, and preparation of summary reportsSupervise and manage day-to-day activities of direct reportsParticipate in developing timelines, protocols and reports for assay transfers, qualifications / validations.Interact with CDMO’s as a subject matter expert to support method transfer and testing activities.Author and review QC analytical SOPs, protocols, and reports as neededMay act as an analytical lab representative on a CMC team.Perform quality management activities such as deviation, CAPA, change control, investigation of OOS, OOT and anomalous results within the company QMS according to established procedures.Maintain QC laboratory, track critical reagents and equipment logbooks, and ensure all the equipment is calibratedUtilize the LIMS system to submit samples, enter data, and track samples.Utilize statistical analysis software to generate assay control charts and recommend assay acceptance criteria.Learn and become proficient in all laboratory instrument software to conduct testing.Establish laboratory and participate in hiring QC staffWho You Are:You have a bachelor’s degree along with 7 years or MS with a minimum of 5 years of experience of relevant industry experience.You are or you also have:Experience in pharmaceutical industry 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 roleExperience in optimizing methods with particular emphasis on cell-based potency assay, molecular biology assay, and protein chemistry assays.Experience with related instrumentation and software used for cell-based potency assays such as JESS, droplet digital PCR systems, cell counters, PLA, etc.Significant experience in an FDA-regulated environmentEntrepreneurial spirit, with strong willingness to take on new challenges required to bring novel medicines to the clinicExcellent organizational and communication skillsNice to have (but not required):Experience with JMP statistical software a plusWhere You’ll Work This role is based out of our San Diego office and requires full-time, in-person presence to support hands-on collaboration, access specialized equipment, and/or operational needs.Travel RequirementsMinimal travel expectedPay Range:$124,000.00-161,000.00 AnnualLife 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 collaboration401(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 insuranceCompany Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunitiesEmployee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give backEligibility 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 View email address on click.appcast.io 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.SummaryLocation: Research Development Lab - San DiegoType: Full time