Scientist II, CMC Analytical Development

PepGen•Boston, MA

4d•Onsite

About The Position

The Scientist II, Analytical Development will be a key member of the Analytical Development group at PepGen. The successful candidate will have great opportunities to use state-of art instruments for studying various potential drug candidates to ultimately create transformational therapies for patients with neuromuscular disease. The candidate will lead method development, impurity characterization and provide analytical support for in-house drug discovery and development activities. The successful candidate also will work very closely within AD/QC and with CMC teams to develop and optimize the methods, support analytical comparability for various chemical entities like peptides, oligos and RepGen's proprietary enhanced delivery oligonucleotides (EDOs), which is essential to the quality of therapies for patients. This is lab-based role that will be on-site for 5 days/week.

Requirements

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
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.

Nice To Haves

Experience in method transfer, qualification, and validation of chromatographic methods (HPLC, GC, LC-MS, etc.) is preferred.

Responsibilities

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.