Associate Director - Analytical Development (Oligonucleotide)

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%).

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