Associate Director, Analytical Development

Associate Director, Analytical Development

Reporting to the Executive Director, Analytical Development & QC, the Associate Director, Analytical Development will be managing the internal lab, supporting the analytical development needs of Pep Gen's pipeline. The successful candidate will have great opportunities to manage a lab with state-of art instruments, like UHPLC-TOF, UHPLC-MS/MS, etc. for studying various potential drug candidates to ultimately create transformational therapies for patients with neuromuscular disease.

The candidate will lead internal method development, extended characterization and analytical support for drug discovery and development in-house and at contract testing labs. The successful candidate will manage their team to work very closely within AD/QC, and with CMC and discovery teams to develop and qualify chromatographic and LC-MS based methods for characterization of various chemical entities like peptides, oligos and Pep Gen's proprietary enhanced delivery oligonucleotide (EDOs), which is essential to the quality of therapies for patients.

In addition, this candidate will play a critical role in building a strong analytical development/QC team at Pep Gen.

• Manage the internal analytical development lab by continuously assessing new technologies and implementing them to support the needs within AD/QC and from multiple cross-function teams.
• Lead the development of analytical methods for the purity/impurity 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 sample management, sample analysis/characterization, and issuance of certificate of testing (COT), etc.
• Perform/guide routine maintenance of analytical equipment, HPLC systems, balance, pH meters, etc.
• Contribute to analytical method development, validation and transfer (mainly UHPLC-UV and LC-MS methods) at external labs and provide necessary technical support for method troubleshooting at CMOs and CTLs.
• Review 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 as needed.
• Write analytical protocol and report for in-house analytical activities and prepare analytical source documents to summarize analytical activities for regulatory filing.
• Lead extended characterization activities including, but not limited to impurity identification, analytical comparability, method bridging, high-order structure and reference standard characterization.
• Lead analytical comparability strategy and execution.
• Lead critical quality attribute (CQA) assessment for DS and DP.
• Communicate and manage external contract labs for characterization activities.
• Coach, mentor and manage direct reports for daily work and provide support to their career development.
• Work closely within AD/QC and with cross-function teams to initiate and streamline AD related processes.
• Contribute to budget planning by providing key information on extended characterization activities
• Author relevant IND/IMPD sections, briefing books to support regulatory filings
• Foster a culture of collaboration, innovation, discovery, and cutting-edge research culture focused on scientific excellence, open communication, and continual improvement

• Ph.D. in Chemistry or related area and 5+ years' or Masters degree and 8+ years' experience leading teams and projects in analytical development
• Experience with peptides, oligonucleotides, or/and peptide-oligo conjugate
• Experience leading CQA assessment and NDA-enabling characterization
• Experience leading analytical comparability and authoring regulatory filing sections
• Demonstrate prototypical leadership skills, planning, and organizational capabilities
• Effectively implement work plans cross-functionally
• Experience in the development, transfer, and validation of chromatographic methods (HPLC, GC, LC-MS, etc.).
• Familiarity with USP, EP, and ICH guidelines for analytical method development and validation.
• Good 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 a fast paced/dynamic environment.

The estimate…