Compensation
$155,000.00 - $155,000.00 / Yearly
Hours Per Week
40
Number Of Positions
1
Job Description
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 an Associate Director on the Analytical Development team to help us expand what's possible for patients with serious diseases. Reporting to the Director, Analytical Development, you'll provide scientific and strategic leadership for analytical method development, characterization, qualification, validation, and lifecycle management of oligonucleotide-based therapeutics. You will lead a team of scientists and collaborate closely with cross-functional partners across Process Development, Manufacturing, Quality, Regulatory Affairs, and external organizations to develop and execute analytical strategies that support product development from early-stage research through commercialization.
What You'll Do:
In this role, you'll have the opportunity to drive technical excellence, regulatory compliance, innovation, and continuous improvement while building analytical capabilities and ensuring timely delivery of high-quality data to support Insmed's growing oligonucleotide pipeline. You'll also:
Lead analytical development, characterization, qualification, validation, transfer, and lifecycle management of methods supporting oligonucleotide therapeutics
Define and implement analytical control strategies, specifications, stability programs, and impurity characterization approaches to support clinical and commercial development
Serve as a subject matter expert in oligonucleotide analytical technologies, including chromatographic, mass spectrometry-based characterization techniques, impurity profiling, degradation pathways, structural characterization, and specification development
Provide scientific oversight of analytical activities performed internally and at external CRO/CDMO partners, ensuring quality, compliance, and timely delivery
Review and approve analytical protocols, reports, regulatory documentation, and data packages to ensure scientific rigor and data integrity
Author and review analytical sections of regulatory submissions, including INDs, CTAs, BLAs, and NDAs, and support responses to regulatory agency inquiries
Drive implementation of innovative analytical technologies and continuous improvement initiatives to enhance analytical capabilities and operational efficiency
Collaborate with Process Development, Manufacturing, Quality, Regulatory Affairs, and other cross-functional teams to support program milestones and regulatory requirements
Build, mentor, and develop scientific talent while fostering a culture of collaboration, innovation, and continuous learning
Define the long-term analytical development strategy and build organizational capabilities to support current and future oligonucleotide programs
Who You Are:
You have a BS/MS degree along with 6+ years of experience in the biopharmaceutical industry or PhD and 2 years of experience in the biopharmaceutical industry.
You are or you also have:
3+ years of experience managing direct reports including prior experience with training and mentoring other technical staff
Strong expertise in chromatographic techniques, including IP-RP-UPLC, ion-exchange chromatography (AEX), HILIC, and mass spectrometry-based characterization
Strong understanding of oligonucleotide impurity profiling, stability assessment, and specification setting
Nice to have (but not required):
Degree in Chemistry, Biochemistry or related discipline
Ability to define problems, collect data, and draw valid conclusions
Working knowledge of FDA, EMA, ICH, GMP, and global regulatory requirements applicable to oligonucleotide products
Experience supporting regulatory submissions and health authority interactions
Proven ability to manage external CRO/CDMO relationships and analytical outsourcing activities
Ability to interact successfully in a dynamic and culturally diverse workplace
Where You'll Work
This role is based out of our Bridgewater, NJ office and requires full-time, in-person presence to support hands-on collaboration, access specialized equipment, and/or operational needs.
Travel Requirements
This role requires occasional travel (approximately 10%)
LI-ONSITE
LI-MC1
Pay Range:
$155,000.00-201,500.00 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 TotalRewards@insmed.com 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.
Apply here: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjEyNzUxLjEwNDEyQGluc21lZGNvbXAuYXBsaXRyYWsuY29t
Place of Work
On-site
Requisition ID
R3599-3486
