Manager, Quality Control Bioassay
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: 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.
Requirements
- Bachelor’s degree along with 7 years or MS with a minimum of 5 years of experience of relevant industry experience.
- 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 role
- Experience 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 environment
- Entrepreneurial spirit, with strong willingness to take on new challenges required to bring novel medicines to the clinic
- Excellent organizational and communication skills
Nice To Haves
- Experience with JMP statistical software a plus
Responsibilities
- 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.
- Actively participate and manage in the timely execution of all routine QC testing, data review, and preparation of summary reports
- Supervise and manage day-to-day activities of direct reports
- Participate 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 needed
- May 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 calibrated
- Utilize 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 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 with purposeful in-person collaboration
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Manager
