Overview In this role, you will provide scientific and strategic leadership for analytical methods development and lifecycle management of oligonucleotide therapeutics, collaborating across Process Development, Manufacturing, Quality, Regulatory Affairs, and external partners. You will build analytical capabilities, drive regulatory-compliant data packages, and guide the team from early research through commercialization. The position centers on advancing analytics to support a growing oligonucleotide pipeline and delivering high-quality data. You will shape long-term strategy and foster a culture of collaboration and continuous learning.
Compensation / Benefits- medical, dental, and vision coverage
- wellbeing reimbursement and EAP
- generous PTO and family-forming benefits
- 401(k) with company match and equity awards
- Employee Stock Purchase Plan (ESPP)
- Learning Institute and leadership programs
Responsibilities- Lead development, qualification, validation, transfer, and lifecycle management of analytical methods for oligonucleotide therapeutics
- Define analytical control strategies, specifications, stability programs, and impurity characterization
- Serve as SME in oligonucleotide analytics, including chromatography, mass spectrometry, impurity profiling, and degradation pathways
- Provide scientific oversight of analytics with internal teams and external CRO/CDMO partners
- Review and approve analytical protocols, reports, and data packages; ensure data integrity
- Author/review analytical sections of regulatory submissions (INDs, CTAs, BLAs, NDAs) and respond to inquiries
- Drive adoption of innovative analytical technologies and continuous improvement
- Collaborate with cross-functional teams to meet program milestones and regulatory needs
- Mentor and develop scientific talent; foster collaboration and continuous learning
- Define long-term analytical development strategy and organizational capabilities for current and future programs
Key requirements- BS/MS with 6+ years in biopharma or PhD with 2+ years in biopharma
- 3+ years of experience managing direct reports with training/mentoring
- Strong expertise in chromatographic techniques: IP-RP-UPLC, AEX, HILIC
- Mass spectrometry-based characterization expertise
- Solid understanding of oligonucleotide impurity profiling, stability assessment, and specification setting
- leadership and people development
- cross-functional collaboration
- strong scientific communication
- Chromatography: IP-RP-UPLC, ion-exchange chromatography, HILIC
- Mass spectrometry-based analytical characterization
- Oligonucleotide impurity profiling and stability assessment
