The Scientist, 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 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.
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
We are a biotechnology company advancing next-generation oligonucleotide therapies for neuromuscular diseases. Our ambition is to unlock the potential of nucleic acid therapeutics by leveraging the drug delivery capabilities of our proprietary Enhanced Delivery Oligonucleotide (EDO) platform. We are applying this technology across a wide range of indications and are rapidly growing our team at our U.S. headquarters in Boston, Massachusetts.
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.