Senior/Principal Scientist, Analytical Development
The Senior Scientist/Principal Scientist, Analytical Development* will be a key member of the Analytical Development group at PepGen. The successful candidate will lead lab activities associated with method development and analytical support for discovery and development in-house and at contract testing labs. The successful candidate will work very closely with the Head of Analytical Development and QC to develop and validate phase appropriate chromatographic methods, mainly focusing on UHPLC-UV/LC-MS methods for characterization of PepGen´s proprietary enhanced delivery oligonucleotides (EDOs). In addition, this scientist will play a critical role in building a strong analytical development/QC team and shaping analytical CMC strategy for various programs at PepGen.
*Title commensurate with education and experience.
- Develop phase appropriate analytical methods (mainly focusing on UHPLC-UV and LC-MS methods) for the purity/potency analysis and impurity characterization of peptides, Phosphonodiamidite Morpholino Oligomers (PMOs), and Peptide Conjugated Phosphorodiamidate Morpholino Oligomers (PPMOs).
- Lead analytical method transfer (mainly UHPLC-UV and LC-MS methods) to and between Contract Testing Laboratories (CTLs) and Contract Manufacturing Organizations (CMOs) and provide necessary technical support for method troubleshooting at CMOs and CTLs.
- Provide analytical support to internal discovery and development activities, including sample management, analysis/characterization, and issuance of certificate of testing (COT) and certificate of analysis (COA), etc.
- Review and approve method development and validation protocols and reports generated by CTLs and CMOs
- Review drug substance and drug product release and stability testing data generated by CTLs and CMOs. Contribute to investigation and resolution of quality events at CMOs and CRLs, including analytical deviation, out-of-specification (OOS), and out-of-trend (OOT).
- Write analytical protocol and report for in house analytical activities and prepare analytical source documents to summarize analytical activities for regulatory filing.
- Work collaboratively with drug substance/drug product, supply chain, quality assurance and regulatory assurance teams to ensure timely availability of lot release and stability data.
- Lead various lab related activities, including regular instrument maintenance/calibration, lab safety monitoring, purchasing lab consumable, material shipment, etc.
- Foster a culture of collaboration, innovation, discovery, and cutting-edge research culture focused on scientific excellence, open communication, and continual improvement
- BS/MS degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field with at least 10 years relevant experiences or Ph.D. with at least 5 years relevant experiences in analytical method development and validation in pharmaceutical/biotech setting. Title will depend on experience level of the successful candidate.
- Experience in the development, transfer, and validation of chromatographic methods (HPLC, GC, LC-MS, etc.) for peptides, oligonucleotides, and/or PMOs/PPMOs is preferred; candidates with strong experience in small molecule or biologics area will be considered too.
- Experience in drug substance and drug product impurity/degradant characterization for peptides and/or oligonucleotides using various techniques such as HPLC-UV, CE, NMR, and mass spectrometry (MS).
- Familiarity with USP, EP, and ICH guidelines for analytical method development and validation.
- Comprehensive working knowledge of current Good Manufacturing Practices (cGMPs)
- Experience managing/working with quality control release/stability testing at a CTL or CMO is a plus.
- Ability to effectively prioritize and deliver on tight timelines and work in fast pace/dynamic environment.
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 through independent and partnered development pathways and are rapidly growing our team, especially at our U.S. headquarters in Boston, Massachusetts. To learn more, please inquire at the link below, check out our website or follow us on Twitter and LinkedIn.