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hplc cgmp fda peptides analytical development📋 Description
- Lead analytical control strategies for drug substances/products.
- Lead method development/qualification for release and stability.
- Budget/manage analytical activities across global CMOs/CTLS.
- Drive impurity profiling using HPLC and LC-MS.
- Lead method troubleshooting and lifecycle management across programs and CMOs.
- Collaborate cross-functionally with Preclinical R&D, Regulatory, QA.
🎯 Requirements
- BA/BS, MS or PhD in chemistry/biochem with 8+ years' experience.
- 6+ years in Analytical Development and/or Quality Control.
- Analytical methods development for peptides/oligonucleotides.
- Environmental monitoring for sterile drug products is a plus.
- Ability to analyze, trend, and present data; JMP preferred.
- Knowledge of cGMP/ICH/FDA/EU/PMDA regulations.
🎁 Benefits
- Remote work opportunities within the United States.
- Travel to Cambridge, MA several times per year.
- Accommodations available during the recruitment process.
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