Insmed Incorporated · 8 hours ago
Manager, Quality Control – Biological Assays
San Diego, CA
Full-time
Onsite
Mid, Senior Level
$124K/yr - $161K/yr
5+ years expInsmed Incorporated is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. The Manager, Quality Control - Biological Assays will oversee the day-to-day activities of direct reports and collaborate with various teams to develop and validate gene therapy assays for drug product release.
BiotechnologyMedicalPharmaceutical
Responsibilities
Participate in developing timelines, protocols and reports for assay transfers, qualifications / validations
Contribute to establishing material specifications for drug substance and drug products
Author and review QC analytical SOPs, protocols, and reports as needed
Ensure the timely execution of all routine QC testing, data review, and preparation of summary reports
You 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 systems to submit samples, enter data, and track samples
Utilize statistical analysis software to generate assay control charts and recommend assay acceptance criteria
Qualification
Required
Bachelors degree with 7+ years or a Masters degree with 5+ years 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
Significant experience in an FDA-regulated environment
Excellent organizational and communication skills
Preferred
Experience with JMP statistical software a plus
Entrepreneurial spirit, with strong willingness to take on new challenges required to bring novel medicines to the clinic
Benefits
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
Company
Insmed Incorporated
Insmed is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases.
1001-5000 employees
H1B Sponsorship
Insmed Incorporated has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
2024 (6)
2023 (14)
2022 (8)
2021 (1)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
$4.56BKey Investors
CureDuchenne Ventures
2025-06-11Post Ipo Equity· $750M
2024-05-30Post Ipo Equity· $650M
2023-05-08Post Ipo Equity· $0.5M
Leadership Team
Drayton Wise
Chief Commercial Officer
Recent News
BioWorld Financial Watch
2025-12-21
Company data provided by crunchbase