Responsibilities:
- Develop, qualify, scale up, and transfer HPLC-based assays for mass/structural identification, characterization, and impurity determination of siRNA therapeutics and formulations.
- Serve as SME for impurity characterization by understanding technical process unit operations to support program teams and forced degradation studies.
- Develop new strategies to improve impurity profiling of candidates and raw materials.
- Implement innovative, automated platform workflows to increase operational efficiency.
- Author development reports and regulatory filing documents; manage analytical activities internally and externally.
- Maintain HPLC and MS fundamentals for troubleshooting hardware/software.
- Represent analytical sciences in cross-functional early stage development as analytical development program representative (backup/lead).
Qualifications:
- Ph.D. in Analytical Chemistry, Biochemistry, or related with at least 2 years relevant experience.
- Hands-on experience developing UHPLCβhigh resolution MS methods using design of experiments; oligonucleotide LC-assay method development/qualification/transfer/troubleshooting strongly preferred.
- Working knowledge of multidimensional LC-MS strongly preferred.
- Strong documentation and communication skills with internal and external partners (e.g., CMOs/contract testing labs).
- Familiarity with Waters (Empower, Masslynx, UNIFI) and Agilent (Openlab, Masshunter) chromatography data software.
Compensation/Benefits (as stated):
- U.S. pay range: $117,000β$158,200; eligible for annual short-term incentive and annual long-term incentive (e.g., equity). Benefits include medical/dental/vision, life & disability, 401(k) with match, paid time off, holidays, wellness days, and recharge breaks.