Associate Director - Analytical Development (Oligonucleotide)

About The Role

Associate Director, Analytical Development (oligonucleotide-based therapeutics). Provide scientific and strategic leadership for analytical method development, characterization, qualification, validation, and lifecycle management. Lead scientists and collaborate with cross-functional teams (Process Development, Manufacturing, Quality, Regulatory Affairs, and external partners) to execute analytical strategies from early-stage research through commercialization.

What You’ll Do

• Lead analytical development, characterization, qualification, validation, transfer, and lifecycle management of methods
• Define analytical control strategies, specifications, stability programs, and impurity characterization approaches
• Serve as SME in chromatographic and mass spectrometry-based characterization, impurity profiling, degradation pathways, structural characterization, and specification development
• Oversee internal and external (CRO/CDMO) analytical work for quality, compliance, and on-time delivery
• Review/approve protocols, reports, regulatory documentation, and data packages for scientific rigor and data integrityAuthor/review analytical sections of IND/CTA/BLA/NDA; support regulatory agency responses
• Drive innovative analytical technologies and continuous improvement; build and mentor talent; define long-term analytical development strategy

Qualifications

• BS/MS plus 6+ years biopharma experience OR PhD plus 2 years
• 3+ years managing direct reports; experience training/mentoring
• Expertise in chromatography (IP-RP-UPLC, AEX, HILIC) and mass spectrometry-based characterization
• Knowledge of oligonucleotide impurity profiling, stability assessment, and specification setting

Nice to Have

• Chemistry/Biochemistry degree; problem-solving skills
• FDA/EMA/ICH/GMP knowledge; regulatory submission/health authority experience
• CRO/CDMO relationship management; comfortable in diverse environments

Where/Travel

Bridgewater, NJ; full-time, in-person. Occasional travel ~10%.

Pay Range

$155,000–$201,500 annual.

U.S. Offerings (Highlights)

• Medical/dental/vision, mental health support, EAP
• 401(k) match, annual equity awards, ESPP; company-paid life/disability