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Salary: USD 128,000 - 146,000 / annual
PepGen is a clinical-stage biotechnology company developing next-generation oligonucleotide therapies for severe neuromuscular and neurological diseases. The Scientist II, CMC Analytical Development will be a key member of the Analytical Development group, leading method development and analytical characterization efforts for the company's Enhanced Delivery Oligonucleotide (EDO) platform.
In this role, you will work closely with managers and cross-functional teams (AD/QC and CMC) to develop and optimize analytical methods for studying drug candidates. You will lead LC-UV and LC-MS method development for purity analysis and impurity characterization of small molecules, peptides, Phosphonodiamidite Morpholino Oligomers (PMOs), and Peptide Conjugated Phosphorodiamidate Morpholino Oligomers (PPMOs). You will serve as the analytical characterization lead for peptides, oligonucleotides, and peptide-oligo conjugates, independently designing, executing, interpreting, and troubleshooting LC-MS experiments for structural elucidation, impurity identification, degradation pathway assessment, and comparability studies.
Key responsibilities include: providing analytical support to internal discovery and development activities (stability analysis, analytical comparability, forced degradation studies); writing and reviewing analytical protocols and reports; preparing analytical source documents for regulatory filings; performing and guiding routine maintenance of analytical equipment (HPLC systems, balances, pH meters); contributing to method development, qualification, and validation; transferring HPLC and LC-MS methods to external labs; reviewing method protocols from contract testing labs (CTLs) and contract manufacturing organizations (CMOs); proactively identifying technical risks and proposing data-driven solutions; and fostering a culture of collaboration and scientific excellence.
This is a lab-based, on-site role requiring 5 days per week in the Boston office. You will work independently with minimal supervision, making sound scientific decisions and driving projects forward in a fast-paced, dynamic environment.
REQUIREMENTS:
- Ph.D. in Chemistry or related field with 1+ years of relevant experience, OR Master's degree with 5+ years of relevant experience in analytical development in pharmaceutical/biotech setting
- Hands-on method development experience in HPLC and MS (e.g., TOF, QTOF) is mandatory
- 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) 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 in a fast-paced environment
