Insmed Incorporated · 14 hours ago
Manager, Analytical Development
San Diego, CA
Full-time
Onsite
Mid, Senior Level
$127K/yr - $166K/yr
4+ years expInsmed Incorporated is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. The Manager on the Analytical Development team will oversee testing performance, manage testing support, and collaborate with various teams to ensure product characterization and method development.
BiotechnologyMedicalPharmaceutical
Responsibilities
Collaborate with research process development, and QC teams to develop, qualify/validate/transfer analytical methods for process monitoring and drug product release
Collaborate with research and process development teams to determine critical quality attributes CQAs), monitor process and method performance, and troubleshoot as needed
Establish control limits for in-process samples and specifications for drug substance and drug products
Perform laboratory testing to support various non-GMP activities
Develop and own timelines and protocols for assay qualifications and transfers
Author, review, and approve analytical development protocols and reports
Ensure the timely execution of requested development sample testing and preparation of reports as needed
Manage sample forecasting and delivery to internal and external partners
Establish stability plans, manage stability tests and reference standards
Establish and manage AD operations function in AD laboratory, ensuring continued supply of materials, equipment, and reagents and maintaining equipment calibration status
Qualification
Required
PhD in relevant discipline along with 4+ years of relevant industry experience, or Master's degree in a relevant discipline with 7+ years of relevant industry experience, or a Bachelor's degree in a relevant discipline with 12+ years of relevant industry experience
Broad knowledge and expertise in gene therapy product and process characterization assays, including but not limited to: immuno, cell-based, and molecular biology assays, as well as separation techniques (MS, HPLC, CE-SDS)
Experience in the pharmaceutical industry within the analytical development functional group, ideally covering the analytical method and testing lifecycle from development through commercial drug product testing
Experience in transferring methods to a GMP environment
Experience with laboratory and project management software (ELN, Smartsheet, LIMS, etc.)
Excellent organizational and communication skills
Experience with direct reports or managing people
Preferred
Entrepreneurial spirit, with strong willingness to take on new challenges required to bring novel medicines to the clinic
Previous AD lab management experience a plus
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
Will Lewis
Chairman and Chief Executive officer
Walter R. Perkins
Chief Technology Officer
Recent News
2026-01-13
Company data provided by crunchbase