QC Method Transfer and Validation (MTV) associated with analytical method qualification, validation, verification and transfer. Authoring/executing/review of study design, protocols and reports associated with cGMP analytical method qualification/validation/transfer to support Pfizer’s quality programs. Lead a team of personnel to successfully complete method transfer activities to support routine testing of Demo, Engineering, CTM (Clinical Trial Material), product/process validation and commercial batches manufactured at Pfizer for vaccines and gene therapy products.

Led the technical development of parenteral drug products to advance Biogen’s pipeline inclusive of both innovator, partner and biosimilar programs. Managed a group of 4 scientists (2 direct reports). • Specific responsibilities include the design, execution, and oversight of formulation and process development studies, technology transfer of parenteral processes to internal and external manufacturing sites, primary container selection, combination product development, and authoring/review of associated regulatory filings (Monograph, IND/IMPD, and BLA).• Drug product lead on cross-functional CMC teams for multiple programs encompassing various modalities (enzyme, mAb, and bispecific).• Developed high concentration formulations for parenteral delivery of therapeutic proteins for treatment of neurodegenerative and neuromuscular disorders, as well as oncology.• Characterized drug product attributes and evaluate compatibility with fill-finish process and container closure systems prior to Tox and FIH. • Provided guidance on Developability/Early Phase assessment of early-stage drug candidates in collaboration with Research group prior and through R2D.• Reduced Drug Product cycle time by more than 50% for Fast to FIH prior to Tox (9 months to 4 months).• Led or actively participated in Biogen centric cross functional teams.

Led Biologics technical agenda - identify/resolve analytical technical gaps of multiple Biologics portfolio. Analytical support of >20 early to late phase and commercial development of biotherapeutics for I/O, immunoscience, oncology, autoimmune diseases, and genetically defined diseases. Managed a group of 13 scientists (9 direct reports) supporting projects internally and in collaboration with external partners. Provided mentorship and professional development of scientists and associate scientists.• Analytical molecule lead of mAb and Fc-fusion proteins. • Worked closely with PD, AST, and MS&T to support PD design of experiments & MS&T study protocols• Engaged with cross-functional teams to set up a strategy for process control & CQA development for fast-to-FIH molecules• BMS Harmonization SME and Lead to harmonize A280, Caliper, iCE, Glycans, and Titer assays throughout the North America PD organization. Develop Standard Operating Procedures SOP's for multiple assays.• Set up state of the art Biological Development in BMS $280M expansion in Devens, MA. Responsible for aliquoting lab space for PDA, AS&T and Method Development; planning out laboratory layout of equipment, assays and supplies; responsible for $3M+ budget for acquiring new analytical PDA equipment, and managing functionality of PDA labs. • Technical Governance Lead for all biological assets in the Development portfolio. Duties include leverage functional expertise, assess technical readiness, and allow for integrated technical review of CMC output to drive clinical development and commercial manufacture.

Responsible for R&D analytical studies, methods development and characterization per ICH guidelines for analytical assays, manufacturing process validation, stability, cell culture media development, and transfer methodology to Manufacturing and Quality. Managed a group of 2 scientists• Working knowledge of spectroscopic and chromatographic analytical techniques (HPLC-PDA/FL, UPLC/MS, GC/MS, FT-IR) used for the characterization of raw materials, finished product, spent cell culture media and protein quality (charge variants and intact mass glycosylation). Analysis of CRO generated ICP-MS data and correlation to raw material and finished product.• Use of multivariate analysis to predict biomarkers in complex raw materials to predict cell culture performance.• Analytical Project Lead on cell culture media optimization projects with internal and external customers for product quality and biosimilars. • Technical leader and analytical expert in internal and external investigations. Draft and review of associated reports.• Managed the analytical lab during my tenure. Responsibilities include capital expense justification and acquisition of GC/MS and UPLC/qTof; inventory management; supervision/training of associate scientists/scientists; maintaining and reviewing lab notebooks; establishment of SOPs; and integration of raw material characterization data into the LIMS database.

Study of antioxidant defenses and electron transport chain enzyme activity in muscle with lifelong voluntary exercise. • Developed protocol for measuring in vivo rate of ATP production in isolated mitochondria.• Isolation/purification of unnatural oxidized amino acids by solid phase extraction. • Application of solid phase extraction and isotope dilution gas chromatography - mass spectrometry for the analysis of oxidized amino acids. • Mitochondrial and lysosomal morphological changes in muscle using transmission electron microscopy (TEM). • American Heart Association Fellowship (0225194B): Doxorubicin-induced damage to cardiac mitochondrial enzymes