Taking molecules from Research to IND/Phase 1 and beyond:- Collaboration with early research functions to improve antibody developability and research to CMC transition- Pre-formulation and formulation of antibodies and ADCs to develop formulations with reduced post-translational modifications that maintain conformational and colloidal stability - Implemented process development solutions to reduce impact of identified molecular liabilities- Clinical in-use studies- Frozen and lyophilized drug product process development- Material and timeline planning to reach GLP-Tox and GMP manufacturing milestones- CMO selection and GMP Phase 1 Drug Product Process Development/Manufacturing; Person-In-Plant (PIP) during GMP manufacturing- Authoring of study protocols, technical reports, and regulatory documents (relevant IND sections)

As needed freelance consulting for small biotech companies on antibody developability and manufacturing assessments.

CMC Lead for Research Transition Project- Collaborating with Research Asset Lead to design pre-formulation experiments for candidate molecules- Responsible for ensuring the final candidate molecule makes a smooth transition from Research to CMC by providing early input on molecule developability/manufacturabilityFormulation and Drug Product Development CMC representative for a pre-IND biological molecule. Responsibilities include:- Carrying out experiments to identify molecule liabilities and develop a formulation mindful of the target product profile and needs of the project team- Enabling Phase 1 clinical trials by selecting and monitoring the Drug Product CMO- Identifying resource needs for project completion- Presenting work or authoring reports as needed

• Led efforts to make, characterize, and test novel peptide formulations in vitro and in vivo. Developed new methods for testing and dosing the formulations. Presented the results at cross-functional update meetings.• Interfaced with CRO for scale-up and development of novel formulations.• Executed formulation stability studies to support a clinical manufacturing scale process change.

Postdoctoral fellow investigating the immunogenicity of aggregates made of monoclonal antibodies and looking at the interactions between mAbs to improve selection of candidates to move forward in development. Conducted physicochemical and biophysical characterization of mAbs and mAbs perturbed by common manufacturing stressors.

My research focuses on the biophysical, biochemical, and immunological consequences of high concentration drug delivery of protein therapeutics.In particular, my research focuses on several specific systems:1) A panel of proteins engineered with specific surface charges to see the effect of surface charge on a novel high concentration low viscosity subcutaneous protein therapeutic delivery method.2) Investigation of electrostatic and hydrophobic interactions of the complementarity determining regions of two possible leading monoclonal antibody drug candidates to link thermal stability and self-interaction propensity to salt concentration, buffer condition, and pH with amino acid sequence.3) Investigation of in vivo anti-drug antibody immune responses.SkillsLab: Molecular cloning (Gibson), bacterial (E. coli) and mammalian (hybridoma and CHO-K1) protein expression, protein purification (IMAC/his tag, protein A, anion exchange, SEC), protein characterization (FPLC/pure-SEC (AKTA), HPLC-SEC, (Waters), DLS/Zeta potential (Malvern and Brookhaven), SDS-PAGE, DSF, BCA, ELISA, CD, and DSC), mouse models for antibody discovery/pharmacokinetics (PK)/immunogenicity, enzyme kinetics (assay to determine kcat/Km at various conditions), protein crystallization, soft matter SEMSoftware: MATLAB, UNICORN 5.31, UNICORN 7.0, Breeze 2, SoftMax Pro, Sequencher, PyMOL and related protein modeling, Microsoft Office

Working as an Associate with Texas Venture Labs, an Austin area start-up incubator which helps companies with market research and validation, competitive analysis, business models, financial analysis, sales, marketing, and funding strategies in teams of engineering, business, science and law graduate students.

Grew bacterial cell cultures to express laccases in E. coli, purified them on a lab-scale GE-AKTA FPLC via anion-exchange, and characterized size with SDS-PAGE, kinetics with activity assays, and thermal stability with differential scanning calorimetry.

Conducted tensile tests with anode composite films of different carbon to binder ratios to determine the strongest laminate ratio for Li-ion batteries.