Manager, 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 Manager on the Analytical Development team to help us expand what's possible for patients with serious diseases. Reporting to the Associate Director, Analytical Development Operations, you'll have 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). This role is for a working laboratory manager who will be directly involved with testing performance and will own the management and delivery of testing support to support product characterization by collaborating with internal functional groups and will also manage testing performed by external CDMO/CTLs. In addition, this individual will be responsible for sample management and forecasting and method transfer activities to QC.

What You'll Do:

In this role, you'll have the opportunity to supervise 2-4 direct reports and oversee vendors and/or contractors as needed. You'll also:

• 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

Who You Are:

You have a 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.

You are or you also have:

• 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.)
• Entrepreneurial spirit, with strong willingness to take on new challenges required to bring novel medicines to the clinic
• Excellent organizational and communication skills
• Experience with direct reports or managing people

Nice to have (but not required):

• Previous AD lab management experience 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:
$127,000.00-165,500.00 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.