• Oversight of all analytical CMC activities at external vendors for biologics (mAb, bispecifics, Fc-fusion proteins), including both drug substance (DS) and drug product (DP).• Leads development of a phase appropriate, analytical control strategy for biologics (mAb, bispecifics, Fc-fusion proteins) including identification of the quality target product profile and critical quality attributes, justification of product specifications and establishment of test methods to enable product QC and batch release, extended characterization, formulation development, comparability assessments and stability programs.• Manage selection, method development, assay transfer, qualification and work carried out by contract research and manufacture organizations.• Oversee all QC activities at CDMOs producing cGMP DS and DP including development, verification, qualification, and validation of analytical methods.• Authors and reviews CMC sections of regulatory submissions e.g., IND, BLA and supportive source documents.• Leads and participates in cross-functional CMC program teams for biologics. Represents CMC in company-wide program teams.• Participates in CRO/CMO selection, management, and auditing.• Partners with Business Development on due diligence of potential new assets.

• Led the Analytical and Process Development team of eight scientists to meet and exceed corporate goals in Neoantigen Cancer Vaccine program while mentoring and advocating individual team members to achieve their highest professional growth.• Developed and implemented scientific strategies for Analytical Development using state-of-art methods to support accelerated biologic product development, characterization, CQA assessment, comparability following process improvements, and release following Regulatory and ICH guidelines; all to support clinical trials.• Managed resources and progress of Process Development activities, with both internal and external teams, ensuring the CMC group anticipates and meets challenging clinical demands.• Oversaw the selection, resource management, and technical supervision of CROs and CMOs. Maintains a balanced use of internal and external resources to ensure maximal efficiency and prioritization of programs all while ensuring high-quality program deliverables, on time and within negotiated budget.• Authored, reviewed, and approved CMC sections in IND filings for several cancer vaccine programs.• Interacted effectively and transparently with the Manufacturing and Quality Control teams, in supporting tech-transfer activities, process improvements and implementation, investigating out-of-specifications, specification determination, and assay qualification.• Served as a key strategic member of the Cancer Vaccine leadership team, assessing capabilities and processes and providing guidance for best practices and direction for continuous development improvement for the immune oncology programs.• Extensive knowledge of CMC regulatory requirements for biological pharmaceutical products in various stages of development.• Actively communicated development progress with upper management and program teams to meet aggressive corporate timelines while maintaining budget accountability and performance requirements.

• Prepared CMC section in successful Phase 1 IND submissions for several therapeutic checkpoint mAb programs (CTLA-4, GITR, OX40, PD-1) as well as therapeutic cancer vaccines.• Collaborated with Process Development to ensure strong cross-functional collaborations and integrated product development and characterization.• Assessed mAb developability and manufacturability through the identification and quantification of Critical Quality Attributes (CQA) such as deamidation, oxidation, and isomerization levels of mAb candidates. Led analytical team in biophysical characterization and reported mAb candidate characterization results and recommendations to Program Management and corporate partners.

• Provided analytical oversight and guidance to external partners (CMO/CRO) during mAb GMP manufacture. Coordinated with internal and external teams to generate Certificate of Testing (CoT) for pre-clinical and clinical lots of biologic products.• Supervised scientists in the characterization of mAb and other biologics by UPLC, SEC, CGE-SDS, mass spectrometry, Octet, and cIEF.• Developed and implemented mass spectrometry methods to generate characterization data used in CMC IND submissions of multiple therapeutic mAb-based products (IgG1, IgG2, and IgG4). Biophysical characterization included peptide mapping, disulfide bond mapping, intact mass analysis, and glycan profiling.• Demonstrated cross-team collaborative capacity with Research, Manufacturing, CMC Management, Program Management, and Quality (QC and QA) groups.• Developed and executed, in a cGMP environment, analytical QC release test methods for peptide and protein drug products in support of Phase 1 and 2 clinical studies.• Prepared and reviewed technical reports, research methods, standard test methods, and standard operating procedures.

• Supported CMC activities involving areas of mass spectrometry, peptide mapping, and advanced analytical characterization. • Analyzed peptide drug substances (API) and peptide drug products by LC-MS following ICH guidelines to assess lot-to-lot reproducibility of manufacture.• Provided technical and analytical support involving cGMP mass spectrometry analysis with CROs as well as reviewed and approved reports from CROs.• Interacted directly with CMO to optimize ion exchange in downstream processing of peptide drug substances.• LC-MS method development, method validation, and method transfer in compliance with regulatory agency (FDA, ICH, USP) guidelines for improved structural confirmation of peptide drug substance.• Method development of in-process intermediates and final peptide drug substances using MALDI-TOF mass spectrometer.• Identified proteins in complex biological samples by LC-MS/MS using database searches.• Analyzed peptide drug substance by SEC and GPC methods.• Prepared and reviewed protocols, technical reports, and procedural guidelines for mass spectrometry studies.• Mentored junior scientists and interns in method development.• Maintained, troubleshooted, and calibrated mass spectrometry and HPLC equipment.

• Developed analytical LC-MS/MS MRM methods to quantify antigen protein levels in vaccine.• Using MALDI-TOF and 2D gel electrophoresis, identified antigens from bioterrorism agents, (e.g., Bacillus anthracis, Francisella tularensis) which were incorporated into vaccine formulations.• De novo sequenced proteins and peptides by LC-MS/MS.• Identified proteins in complex mixtures by LC-MS/MS and Mascot database searching.• Oversaw the operation of the Proteomics Laboratory including scheduling/prioritizing of experiments, development of procedural guidelines, analysis of MALDI-TOF MS and LC-MS/MS data, and presentation of data to supervisors and collaborators.• Purified recombinant proteins by affinity chromatography.• Prepared and reviewed progress reports for DoD funding agencies (e.g., DARPA, DTRA).• Led junior level scientists in method development and project completion under strict timelines.• Performed general maintenance and calibration of all mass spectrometry equipment.

• Developed a high-throughput screen using differential X-ray crystallography to identify pharmacological lead compounds.• Purified highly pure recombinant non-tagged protein by ion-exchange chromatography.• Solved X-ray structures to high resolution using molecular replacement.