Scientist I, Analytical Development

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 Scientist I on the Analytical Development team to help us expand what's possible for patients with serious diseases. Reporting to the Associate Director, Analytical Operations, you'll have broad knowledge and expertise in cell-based potency assays, molecular biology assays, and chemical/biochemical assays as applied to AAV gene therapy products. You will be involved in method development and method transfer to GMP partners and will perform testing for various developmental lots and studies. You will author and execute phase appropriate qualification and transfer protocols and reports of developed methods to support product release and stability, and perform analysis on characterization, developmental lot release stability samples for clinical phase AAV Gene Therapy products.

What You'll Do:

In this role, you'll have the opportunity to collaborate with research and process development teams to develop and qualify AAV gene therapy cell-based biological potency assays, protein chemistry assays, and molecular biology assays for process monitoring and drug product release (e.g., HPLC, ELISA, CE-SDS, ddPCR, and cell-based potency assays). You'll also:

• Collaborate with QC to author and execute method transfer protocols and reports
• Collaborate with research, analytical and process development teams to determine critical quality attributes (CQAs), monitor process and method performance, and troubleshoot
• Develop and own timelines, protocols and reports for assay transfers, qualifications / validations
• Ensure the timely execution of all routine non-GMP testing, data review, and preparation of summary reports
• Maintain AD laboratory, track materials and reagents, and ensure all the equipment is maintained
• Coordinate with CDMOs / CTLs to manage shipping, testing and reporting of outsourced analyses

Who You Are:

You have a BS degree in a relevant discipline along with 4+ years and relevant industry experience or a Master's degree in relevant discipline with 2+ years of relevant industry experience.

You are or you also have:

• Experience in pharmaceutical industry in an analytical development lab, ideally covering the analytical method and testing lifecycle from development through phase appropriate qualification
• Experience in developing methods with particular emphasis on immunoassays and protein chemistry assays
• Experience in an FDA-regulated environment with a focus on high throughput workflows
• 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 have (but not required):

• Experience with laboratory management software (ELN, Smartsheet, LIMS, etc.) a plus
• Experience with JMP statistical software a plus

Where You'll Work

This role is based out of our San Diego Research Development Lab and requires full-time, in-person presence to support hands-on collaboration, access specialized equipment, and/or operational needs.

Travel Requirements

Minimal travel expected

Pay Range:
$103,000.00-131,000.00 Annual

Life 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 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

Eligibility 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.

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 [email protected] 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.