Associate Director - Analytical Development (Oligonucleotide)

About the role

We’re looking for an Associate Director on the Analytical Development team to help expand what’s possible for patients with serious and rare 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.

Responsibilities

• 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

Requirements

• BS/MS degree along with 6+ years of experience in the biopharmaceutical industry or PhD and 2+ years of experience in the biopharmaceutical industry
• 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

• 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

Schedule

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. Occasional travel (approximately 10%) is required.

Pay

$155,000.00–201,500.00 annual

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support
• Annual wellbeing reimbursement and access to 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 Employee Stock Purchase Plan (ESPP)
• 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.