Scientist II Analytical Development, LC Method Expert
Overview
As Scientist II in Analytical Development, you own LC method development and serve as the LC subject matter expert for synthetic drug substances and products. You lead analytical strategy from early to late stage, interfacing with CMC, formulation, process development, and quality teams. Your lab-based role in Cambridge, MA drives robust, stability-indicating methods with HPLC, UHPLC, and LC-MS. You also oversee CDMO activities and contribute to emerging modalities like oligonucleotides and peptides. This position blends deep technical expertise with cross-functional leadership, shaping the analytical landscape of drug development.
What You'll Do7
- 1Lead LC method development, optimization, qualification, and troubleshooting with HPLC, UHPLC, and LC-MS.
- 2Develop robust, stability-indicating methods for synthetic drug substances and products, ensuring regulatory compliance.
- 3Shape analytical strategy for development programs from early to late stage, aligning with cross-functional teams.
- 4Provide technical oversight of analytical activities at CDMOs, including method validation and transfer.
- 5Manage method lifecycle to meet regulatory expectations per ICH guidelines.
- 6Mentor junior scientists and share knowledge to build analytical capability within the team.
- 7Drive innovation by contributing to programs involving emerging modalities such as oligonucleotides and peptides.
Requirements6
- 1Ph.D. with 0-3 years or M.S. with 4+ years or B.S. with 6+ years of relevant pharmaceutical or biotech experience.
- 2Deep expertise in small molecule LC method development, with strong HPLC/UHPLC skills and familiarity with LC-MS.
- 3Proven ability to lead analytical activities for drug development programs.
- 4Solid knowledge of ICH guidelines and experience in regulated (GMP/GLP) environments.
- 5Excellent problem-solving, communication, and cross-functional collaboration skills.
- 6Preferred: Experience with oligonucleotides and/or peptides, and advanced MS techniques like LC-MS/MS and HRMS.
Salary Insight
$117 - $157k per year
Location
Required Skills
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