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2023
• Overseeing process development activities for cell therapy modalities including autologous CAR-T, allogeneic, and TCR-T platforms and delivering a high-quality manufacturing process for multiple clinical stage programs • Managing a team of scientists, associates, contractors, and consultants across multiple sites • Authoring IND sections, responding to regulatory requests, and implementing a phase-appropriate approach to CMC life-cycle management • Successfully delivering milestones needed to satisfy an acquisition by a major pharmaceutical company
2023
2023
2023
2023 - 2023
2023 - 2023
• Technical operations, process development, GMP, and CMC expert in multiple modalities including cell and gene therapies, live biotherapeutic products, biologics, DNA/RNA, etc. • Expertly trained in synthetic biology, cell and molecular biology, gene editing, genomics, and bioengineering • GMP, quality, and regulatory support of novel modalities for global regulatory agencies • Scientific advisor and board member offering support on research and development, technical strategy, business development, and financing • Venture partner providing due diligence on technical aspects in various biotech sectors • Entrepreneur in residence supporting technology transfer, part-time C-suite, academic/industry relationships, and early-stage company guidance
2020 - 2023
2022 - 2023
• Leading multiple high-performance teams across Process Development, Manufacturing, Quality, CMC, and Clinical Supply for genetically modified cell therapies, and successfully delivering cGMP clinical drug product to Phase 1/2 subjects • Successfully overseeing the technology transfer and manufacturing of drug substance and drug products at CDMOs, with release of multiple batches of study product for clinical trials • Drafting and submission of IND modules, regulatory feedback, and technical documents; leading to an approved IND in a novel modality • Managing a budget to ensure company operations, delivery of high-quality drug product, and CDMO contract execution • Building teams and hiring core staff across functional areas and operations verticals
2020 - 2022
2020 - 2020
2020 - 2020
• Leading programs in research and development, process development, quality control, and manufacturing to create a cell therapy and exosome platform for therapeutic indications in infectious disease, oncology, and inflammation
2018 - 2020
2018 - 2020
• Leading scientific efforts, fundraising, growth, budgets, and the overall strategy of the company • Developing a platform to enable the discovery of novel microbes associated with marine hosts • Development of bioactive compounds, protein, and specialty chemicals in novel marine microbes
2015 - 2020
2018 - 2020
• Process Development and CMC lead for live cell modalities including CAR T-cell therapies, neoantigen immunotherapy, and gene editing • Project Team Lead (PTL) for TCR-T cell therapy programs, Attribute Sciences Team Lead (ASTL) for CAR-T cell therapy program, Early Operations Lead (EOL) for neoantigen immunotherapy program
2015 - 2018
• Managing a team composed of PhD scientists, associate scientists, and senior associates to develop and execute bioassay, immunoassay, and molecular assays for release of large molecule therapeutics
2015 - 2019
2015 - 2019
• Serving as an investment consultant to provide assessments and scientific due diligence for funding of biotechnology companies
2014 - 2015
2014 - 2015
• Combining CRISPR genome editing tools and next-generation sequencing to address the regulation and evolution of gene expression and human disease