Associate Director - Analytical Development; Oligonucleotide
Job in
Bridgewater, Plymouth County, Massachusetts, 02324, USA
Listed on 2026-08-30
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-08-30
Job specializations:
-
Research/Development
Pharmaceutical Science/ Research, Regulatory Compliance Specialist, Research Scientist
Job Description & How to Apply Below
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 integrity
Author/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
- 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
- Chemistry/Biochemistry degree; problem-solving skills
- FDA/EMA/ICH/GMP knowledge; regulatory submission/health authority experience
- CRO/CDMO relationship management; comfortable in diverse environments
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
Position Requirements
10+ Years
work experience
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