Scientist II, CMC Analytical Development

• →Work closely with managers to develop analytical methods (LC-UV and/or LC-MS) for the purity analysis and impurity characterization of small molecules, peptides, Phosphonodiamidite Morpholino Oligomers (PMOs), and Peptide Conjugated Phosphorodiamidate Morpholino Oligomers (PPMOs).  
• →Provide analytical support to internal discovery and development activities, including stability sample analysis/characterization, analytical comparability, and forced degradation sample preparation and characterization. 
• →Write and review analytical protocol and report for in-house analytical activities and prepare analytical source documents to summarize analytical activities for regulatory filing. 
• →Perform/guide routine maintenance of analytical equipment, HPLC systems, balance, pH meters, etc.; contribute to new instrument setup. 
• →Contribute to analytical method development, qualification/validation and transfer of HPLC and LC-MS methods at external labs and provide necessary technical support for method troubleshooting at CTLs/CMOs. 
• →Review method development and validation protocols and reports generated by CTLs and CMOs (mainly LC-MS methods) as needed 
• →Foster a culture of collaboration, innovation, discovery, and cutting-edge research culture focused on scientific excellence, open communication, and continual improvement.  
• →Serve as the analytical characterization lead for peptides, oligonucleotides, and the peptide-oligo conjugates, utilizing advanced LC-MS methodologies to support process development, product understanding, and regulatory filings.  
• →Independently design, execute, interpret, and troubleshoot LC-MS experiments for structural elucidation, impurity identification, degradation pathway assessment, and comparability studies. 
• →Proactively identify technical risks, propose innovative experimental approaches, and recommend data-driven solutions to advance development programs. 
• →Self-motivated scientist with a demonstrated ability to work independently, make sound scientific decisions, and drive projects with minimal supervision. 

• Ph.D. in Chemistry or related area and 1+ years’ or MS degree and >5 years’ relevant experience in analytical development in pharmaceutical/biotech setting.
• Hands-on method development experience in HPLC and MS (e.g. TOF, QTOF, etc.) is a must. 
• Deep hands-on experience with LC-MS characterization of complex molecules, including impurity profiling, degradant identification, and structural elucidation.
• Experience with peptides and oligonucleotides
• Experience in method transfer, qualification, and validation of chromatographic methods (HPLC, GC, LC-MS, etc.) is preferred.  
• Good working knowledge of current Good Manufacturing Practices (cGMPs) or Good Lab Practices (GLP) is a plus.   
• Working knowledge of CMC (Chemistry, Manufacturing, Control). 
• Familiarity with analytical support for early discovery and formulation development is a plus.  
• Ability to effectively prioritize and deliver on tight timelines and work in a fast paced/dynamic team environment

About PepGen

PepGen is a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen’s Enhanced Delivery Oligonucleotide (EDO) platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates designed to target the root cause of serious diseases.

For more information, please visit PepGen.com. Follow PepGen on LinkedIn and X.

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