Constance W.

Analytical lead for a drug substance workstream of a complex fixed-dose combination injectable product: Led analytical readiness activities supporting the supplier drug master files for US, EU and China. Analytical lead for the development of a COVID-19 injectable anti-viral (PF-07304814): The COVID-19 injectable antiviral program was the original LIGHTSPEED program initiated during the pandemic. The global team accomplished FIH to Phase 3 in 4 months and ICH manufacture in 12 months. Contributing member of the PSSM Lake Forest Diversity Equity and Inclusion team that was widely recognized for highly engaging on-site Chicago-area community programming.

Led global initiative across Pharmaceutical Sciences Small Molecule and Medicinal Sciences to evaluate cyclodextrin / small molecule complexes by ion mobility mass spectrometry. Multi-part project culminating in one manuscript publication and a second manuscript intended for peer-reviewed publication. Led Knowledge Management Core Team to implement a mechanism for lessons learned review, establish updated workflows for parenteral IV development, and design a Knowledge Management SharePoint site. Supported global analytical team for the development of a COVID-19 injectable anti-viral (PF-07304814).

Authored impurity characterization report and CTD section 3.2.P.5.5 for Bradykinin B2 receptor ANDA submission. Defined ANDA submission CMC sameness strategy testing plan and short-term timelines for a GLP-1 analog direct copy and alternate formulation programs. Led development and execution of NMR sameness plan including strategy for data collection, compilation, and computational analysis with a cross-functional team of SMEs. Led outsourcing of method development activities to support ANDA submission.

Technical lead for two biosimilars programs to define strategy, manage outsourcing testing and data review, and compile structural and functional data. Bioassay functional lead for the erythropoietin, pegfilgrastim, filgrastim and PD-1 programs. Retacrit (epoetin alpha) and Nivestym (filgrastim) were approved in 2018 and Nyvepria (pegfilgrastim) was approved in 2020. Led functional area internal testing, managed outsourcing testing (GMP and early stage) and method qualification / validation strategy for a key asset. Authored key regulatory and scientific documents. Lake Forest Analytical Research & Development Change Agent and Certified Pfizer Trainer.

Managed CRO GMP bioassay testing data for the erythropoietin project. Authored and verified scientific documents. Reviewed scientific data for multiple biosimilar programs.

Lead for Baxter Analytical Contract Research Organization (CRO) Strategic Partnership Scientific review of CRO original data associated with Nuclear Magnetic Resonance (NMR) reference standard evaluation, validation and characterization studies Supporting products in early stage development through commerical Core Team member for international teleconferences with CRO from India Responsible for scientific review of Baxter NMR method development data

Responsible for confirmatory studies of raw material change control of commercial products and analytical method development studies Approver for cGMP studies to demonstrate alternative raw materials did not impact process or product Report writing and editing for various groups, including Particles & Interfaces, Analytical Method Development, Trace Metals and Structure Elucidation Understand and apply key regulatory and quality documents (GMP, GLP, GDP)

Responsible for teaching general chemistry theory and laboratory techniques

Taught lecture courses covering chemistry, organic chemistry and biochemistry Responsible for teaching general chemistry theory and laboratory techniques

Biomolecule Structural Analysis subgroup (Functional Manager) and Core Team member of Biochemistry subgroup* Baxter Technology Resources Achievement Award for Firefight (2006) Baxter Corporate Technical Award, Outstanding Team (2004) Baxter Technology Resources Achievement Award for Green Chemistry (2002) Technical lead for junior scientists Direct supervisor for interns Directed projects involving multiple groups, such as Biochemistry, Particulate Analysis, Mass Spectrometry and Trace Metals Supported IND enabling preclinical studies Developed and executed bioanalytical assays for enzyme activity, protein quantitation, antibody neutralization and quantitation of small molecules Validated bioanalytical methods for quantitation of small molecules and measuring antigen concentration Characterization of multiple lots of recombinant glycoprotein by N-linked oligosaccharide profiling Selected for troubleshooting work of large and small molecules of products at all stages of development and commercial product Face to face discussion with FDA as part of commercial product investigation Selected for task force teams: Reference Standard Qualification, Validation and Pharmacokinetic *Performed some of these duties as a Research Associate III from 2001-2002.

Senior Technical Writer Authored multiple sections of an IND Editing of manuscripts and successful Small Business Innovation Research (SBIR) grants Selected for team on outside research collaboration Member of internal research management committee

Undergraduate Research and Teaching Studied the isotope effect on alkenylation reactions with toluene and 1,4-butadiene. Teaching Assistant for Physiology, Qualitative Analysis and Organic Chemistry courses

Researched low-barrier hydrogen bonds in enzymatic catalysis. Examined chymotrypsin and inhibited complexes by proton and deuterium NMR. Studied model compounds using NMR and FTIR. Teaching Assistant for a Biochemical Techniques lab course. Supervised undergraduate research in the laboratory.

Research mechanism of action of microsomal epoxide hydrolase utilizing site-directed mutagenesis to identify critical residues by steady-state and stopped-flow kinetics with various substrates. Laboratory techniques included site-directed mutagenesis, protein expression, kinetics and 1D NMR (proton and carbon)