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Scientist I/II, CMC Analytical Development
2 months ago
Scientist I/II, Analytical Development
Position Summary
The Scientist, Analytical Development/CMC 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 and provide analytical support for in-house drug discovery and development activities. The successful candidate also will work very closely with experienced CMC and discovery teams to develop and qualify phase-appropriate analytical methods for various chemical entities like peptides, oligos and PepGen´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 5 days/week.
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 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 routine maintenance of analytical equipment, HPLC systems, balance, pH meters, etc.; contribute to new instrument setup.
- Foster a culture of collaboration, innovation, discovery, and cutting-edge research culture focused on scientific excellence, open communication, and continual improvement.
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. Title will depend on the experience level of the successful candidate.
- Hands-on method development experience in HPLC and MS (e.g. TOF, QTOF, etc.) is a must.
- Experience in the method transfer, qualification, and validation of chromatographic methods (HPLC, GC, LC-MS, CE, 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 the Team
We are a team of passionate and creative scientists committed to analytical development and quality control of innovative EDO platform. We value honest communication with open mindset. We are looking to enhance our group with another collaborative team member who shares our values, excitement about the possibilities our EDO platform offers and commitment to make a meaningful difference for patients.
About PepGen
PepGen Inc. 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, or 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 that target the root cause of serious diseases. For more information, visit www.pepgen.com or follow PepGen on Twitter and LinkedIn.
EEO Statement
PepGen is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.
Recruitment & Staffing Agencies
PepGen does not accept unsolicited agency resumes. Currently, we are working exclusively with The Bowdoin Group for all our recruiting needs. Thank you.
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