Protein Target Development & Management. Interfaces with Biosynth leads, partners, clients, and contractors to coordinate and manage protein and antibody development projects.

1. Design, management & development of proteins, antibodies, recombinant antibodies, and cell line projects for Structure, assays and Screens. Antibody (pAb and mAb) development and humanization (IgG and IgM), stable clonal cell line and hyper-expression cell line development for proteins and antibodies through GMP. Isolation and assays of SARS Spike and Orf proteins. Process establishment, & guidance to Pharma, biotech, Academia & CROs/CMOs, from early discovery to GMP, and clinical… Show more 1. Design, management & development of proteins, antibodies, recombinant antibodies, and cell line projects for Structure, assays and Screens. Antibody (pAb and mAb) development and humanization (IgG and IgM), stable clonal cell line and hyper-expression cell line development for proteins and antibodies through GMP. Isolation and assays of SARS Spike and Orf proteins. Process establishment, & guidance to Pharma, biotech, Academia & CROs/CMOs, from early discovery to GMP, and clinical development.2. Providing Strategic & Operational biological & biotherapeutic outsourcing processes. Consulting & market analysis of pharma industry and CRO landscape. CRO development and project management. 3. Global vendor identification & engagement. Program & project management. Development of customer/vendor relationships, & establishment of process improvement platforms & guidelines. Show less

1. Collaboration and Consulting with global Pharma, CROs, CMOs. and CDMOs2. Development, generation, and analysis of drug targets and antibodies in support of small molecule and Biotherapeutic drug discovery programs. Work spans gene-to-protein customer support in prokaryotes and eukaryotes, protein and antibody modification, biochemical and biophysical assay method development, and post-production analysis and validation.3. Managing, executing, and advancing global outsourcing… Show more 1. Collaboration and Consulting with global Pharma, CROs, CMOs. and CDMOs2. Development, generation, and analysis of drug targets and antibodies in support of small molecule and Biotherapeutic drug discovery programs. Work spans gene-to-protein customer support in prokaryotes and eukaryotes, protein and antibody modification, biochemical and biophysical assay method development, and post-production analysis and validation.3. Managing, executing, and advancing global outsourcing collaborations with Pharma, Academia, and Biotechs. Show less

Vendor management, preclinical and clinical development, drug validation, characterization, and external research. Senior global project management role and cross-functional leadership for US and UK. Directed a global external Pfizer portfolio in support of small and large molecule drugs. Developed scientific processes and target protocols. Developed & managed global sourcing portfolios and strategies across multiple research units and sites (pre-clinical to clinical) for US & ROW (EU, AU… Show more Vendor management, preclinical and clinical development, drug validation, characterization, and external research. Senior global project management role and cross-functional leadership for US and UK. Directed a global external Pfizer portfolio in support of small and large molecule drugs. Developed scientific processes and target protocols. Developed & managed global sourcing portfolios and strategies across multiple research units and sites (pre-clinical to clinical) for US & ROW (EU, AU, Asia) vendors. Established drug targets for NCEs and Biotherapeutics (vaccines, ADC) in collaboration with internal and external partner. Built platforms and strategies, developed and implemented best practices and guidelines. Identified, engaged and managed multiple external partners (CROs/CMOs).Managed several $MM budgets with corporate reporting responsibility to global disease areas.Expanded portfolio to support all pre- and clinical targets, cell line dev., assays, biomarkers and proteomics.Advanced >12 drug candidates for small molecule, biotherapeutics, Biosimilars and ADC hybrids (Xeljanz, Torcetrapib, Tenazumab, rituximab, trastuzumab, Insulin, Leptin, Insulinotropin).Trained in GMP. Guided vendor diversification into biotherapeutics and GMP production.Developed and managed a strategy for biotherapeutics that achieved a 12-fold portfolio growth in 2 years.Developed short term and long term strategies that increased the portfolio, and reduced timelines and cost by 50%.Developed global best practices. Streamlined CROs core partnerships. Negotiated savings of 35%Organized and led several Symposia. Established broad contact base throughout the Pharma industry, Academia & Biotech. Represented Pfizer at major leadership events. Published book chapters, delivered keynotes in US and overseas. Show less

Protein Biochemist with experience in all aspects of pre- to clinical processes. Directed an internal protein purification portfolio, and external Biology Outsourcing portfolio that globally affected hundreds of research programs for Gene-to-Protein, DNA, Cells, purification, Biophysics, and Biomarkers, supporting all areas of drug discovery (Assay, Structure, Safety, Biomarker, Biologics, ADME). Directed Pfizer strategic sourcing process for the US, EU and Japan sites.Project management… Show more Protein Biochemist with experience in all aspects of pre- to clinical processes. Directed an internal protein purification portfolio, and external Biology Outsourcing portfolio that globally affected hundreds of research programs for Gene-to-Protein, DNA, Cells, purification, Biophysics, and Biomarkers, supporting all areas of drug discovery (Assay, Structure, Safety, Biomarker, Biologics, ADME). Directed Pfizer strategic sourcing process for the US, EU and Japan sites.Project management and oversight of business and science operations. Aligned globally with Project teams, Scientists and functional support lines. Connected to big Pharma outsourcing leads. Delivered scientific and process improvement presentations. Identified and managed of CROs. Developed and managed a 10-year strategy. Achieved a 100X portfolio growth with only 7X cost increase. Managed a database of 12,000 Pharmaceutical targets.• Developed, implemented and managed strategies, identified and engaged vendors, set guidelines, mentored process and communicated with stakeholders and management. • Led a cross-functional Procurement and Ariba team. Delivered a management tool for 4000 preclinical, clinical, and biotherapeutic targets.• Partnered across Discovery and streamlined CROs to 50 vendors. Consolidated reagent processes to deliver >800 cell lines, cell banks and protein targets for pre- and clinical research.• Partnered cross-loop with 3 CROs to advance Torcetrapib to phase 3 with 2-yr savings of >$10MM.• Presented data at symposia and meetings throughout the US.• Collaborated with academic partners at Yale, Princeton, Columbia, Scripps, Georgetown. Show less

•Directed the strategy and operation of the Pfizer protein bioanalysis facility•Introduced state-of-the-art biophysical & biochemical tools for target validation (CE, QELS, AFFF, FS, SLS)*Led the process to create and validate protein targets for pre- and clinical use*Successfully challenged established scientific theories around difficult targets (Tau, CETP, BACE, FcRn)•Led a team to successfully address multiple challenges in protein purification that had resulted in failures… Show more •Directed the strategy and operation of the Pfizer protein bioanalysis facility•Introduced state-of-the-art biophysical & biochemical tools for target validation (CE, QELS, AFFF, FS, SLS)*Led the process to create and validate protein targets for pre- and clinical use*Successfully challenged established scientific theories around difficult targets (Tau, CETP, BACE, FcRn)•Led a team to successfully address multiple challenges in protein purification that had resulted in failures of downstream process development•Project management, staff management, daily oversight of business, budget, and science operations•Partnered with 300 global customers & Analytical R&D to provide target analysis and validation for clinical targets.•Partnered with global institutions to validate clinical biotherapeutics & vaccine injectables•Introduced technologies for carbohydrate & lipid analysis of protein, and cell targets for MMP1 & torcetrapib•Neuroscience-Isolated and studied biophysical properties of Alzheimer’s target Tau tangle formation Established non-conformity to the Einstein-Simha equation. Established amyloid dimer toxicity and BACE fast-refolding. Developed validation assays for clinical brain barrier transport in CovX bodies. Achieved savings >$2MM. Established a biomarker partnership for Tau•Inflammation-First to solve the human collagen sequence and refold stable catalytic MMP1. Co-developed 2 commercial Mass Spec. & ELISA-based biomarker diagnostic assays for arthritis with U. Virginia•Animal health-Advanced cow mastitis drug, studied viable vaccines and infectious flagellar proteins by SLS•Metabolic-Tasked by FDA and EMA to evaluate and recommend a path for inhalable insulin in CP3. Discovered adiabatic aggregation. Recommended device redesign with “Inhale”•CMC/CQA-Partnered with clinical development, Installed tools for QTPP & HCP/DNA analysis. Evaluated the drug Aricept contaminants. Recommended API remanufacturing. Developed PK/PD clinical assays for CETP Show less

* Initiated external research at Pfizer to support expanded drug discovery target need. Setup and managed portfolio and vendors. developed and implemented best practices.* Managed an internal protein biochemistry portfolio with focus on Inflammation, Immunology, cardiovascular and Neuroscience.* Evaluated 225 CROs for protein purification. Trained and engaged 50 CRO partners in the US, EU and Asia.* Partnered with 12 academic institutions in the US and EU to advance IP… Show more * Initiated external research at Pfizer to support expanded drug discovery target need. Setup and managed portfolio and vendors. developed and implemented best practices.* Managed an internal protein biochemistry portfolio with focus on Inflammation, Immunology, cardiovascular and Neuroscience.* Evaluated 225 CROs for protein purification. Trained and engaged 50 CRO partners in the US, EU and Asia.* Partnered with 12 academic institutions in the US and EU to advance IP research.* Co-developed 5 global proprietary tracking, requesting, and sourcing tools to manage Pfizer programs. * Led cross-functional and multidisciplinary teams. Advanced complex projects into outsourcing. Show less