Werewolf Therapeutics develops innovative conditionally activated cytokine therapeutics with improved PK and safety profiles.

Analytical and formulation developmentQuality control

Lead analytical and formulation activities :- Develop, qualify and transfer analytical methods for monoclonal antibody and ADC release and stability testing. - Develop cutting-edge technology for product and method characterization- Design, plan and lead formulation studies for naked antibody, ADC DS and DP- Manage CMO QCA activities including designing stability programs, reviewing sampling plans and reviewing release and stability data- Collaborate with other function groups and devise plans for comparability studies to support process changesManufacturing activities:- Manage CMO DP production including reviewing CMO SOPs and MBRs- Review EM reports and devise CAPA to address EM positive findingsRegulatory activities:- Author related CMC sections for IND, INDa and AR filing-Participate in meetings with regulatory agencies

Worked for Agensys a subsidiary of Astellas Led the In-process analytical group to support Agensys mAb and ADC process development.Provided analytical support and strategy for cell culture, purification and conjugation process development and in-process testing.Developed high-throughput analytical assays to accommodate high sample testing demand from multiple pipeline projects.Deep characterization of mAb and ADC to enable molecule optimization and clone screening.

Developing analytical methods to support upstream and downstream processes, product characterization and product release/stability for monoclonal antibodies and fusion proteinsExperienced with following analytical techniques: Major modes of HPLC including SEC, IEX and RP for protein purity determination, impurity characterization, stability tracking and product release CE-based separation techniques such as capillary CE-SDS for purity determination TOF-based methods for intact or partially digested protein characterization LC-MS or CE-MS peptide mapping for protein sequence confirmation and PTM determination HILIC- or CE-based methods for monoclonal antibody glycosylation profilingDetermining molecule critical quality attributes and developing corresponding control strategies.Executing qualification and transfer of analytical methods and authoring technical documentsContributing to CMC drafting and responding to agency questionsTraining and supervising new hires on multiple analytical assaysActing as analytical lead to manage method development strategy and timeline

Development of ultra-fast capillary electrophoresis with laser-induced fluorescence detection for enzyme assayDevelopment of a multi-channel lab-on-a-chip with fluorescent CCD imaging for high-throughput drug screening and GPCR-directed drug discoveryInvention of a digital microfluidic interface to ESI-MS for fast acetylcholinesterase inhibitor screening