• Authors CMC stability sections for IND, CTA, NDA/BLA to support global investigational and registrational submissions and Annual Reports.• Reviews CMC sections for IND, CTA, NDA/BLA to support global investigational and marketing application submissions for biologics and small molecule compounds.• Working knowledge of ICH guidelines, FDA and EMA regulations, USP and Ph.Eur. • Manages stability programs for clinical development projects for biologics and small molecule compounds.o Stability lead for Opdivo (breakthrough designation and immuno-oncology therapy) from phase II through BLA and MAA registrational filings.o Stability lead for three projects with a monoclonal antibody therapy. o Leads stability for clinical use and global regulatory filings for parenterals, tablets, capsules, and comparators.

• Reviewed and assembled CMC sections for MAAs, Type II variations, renewals, and regulatory correspondence to create EU national CMC commercial product dossiers in a documentum database. • Created CMC chronological logs by authoring summaries of registrational applications, renewals, variations, and regulatory correspondence. • Utilized functional area and global documentum databases to update CMC regulatory information and performed gap analysis to assist product managers.

• Approved stability study reports of commercial products for regulatory submissions and post approval reports.o Reviewed and ensured compliance with stability protocols and registration specifications for US, MOW (Most of World), and ROW (Rest of World).• Approved test method validation reports and analytical research reports.o Ensured compliance with regulatory agencies (FDA, EMEA), guidelines (ICH), compendia (USP, EP, and JP), and internal procedures (SOPs).

• Conducted multi-step synthesis of lead compounds and analogs for biological assays and multi-step scale-up of intermediates as part of oncology and cardiovascular discovery teams in an integrated multidisciplinary (chemistry, biology, pharmacology, crystallography) environment.• Purified compounds and intermediates utilizing column chromatography, HPLC, and TLC techniques, and characterized target compounds using NMR, LC-MS, and HPLC.• Assisted with drafting of patent applications and proofreading of drafts. • Supported lead optimization for selection of clinical candidates for parenteral and oral Factor VIIa cardiovascular programs.

• Performed receptor/binding, enzymatic assays and ELISA.• Conducted HTS using: multidrop, rapid plate, top count scintillation counter, and plate reader.• Experienced with handling of radioisotopes, cell isolation, and purification.• Conducted multistep and single step syntheses of potential drug intermediates for biological targets.• Purified and characterized intermediates by TLC, NMR, and mass spectrometry.

• Conducted routine and non-routine analytical testing of finished products (release testing), raw materials, and in-process samples in a GMP environment.• Utilized GC, HPLC, AA and UV/VIS Spectrometers, physical and wet chemistry techniques.• Maintained and conducted troubleshooting of thirteen GC instruments, one HPLC instrument, and one atomic absorption spectrophotometer.