Experience

Atea Pharmaceuticals, Inc

• United States
• Biotechnology Research
• 1 - 100 Employee

• Associate Director- CMC

  • Oct 2020 - Present

  Boston, Massachesettes API (DS) lead for AT-752, a clinical candidate for anti-viral applications. Responsible for process R&D; delivery of API to meet clinical needs; providing supporting documents for regulatory filing. Managing external vendors for process research and development; providing scientific and technical guidance; developing a practical, free-to-operate, and ready to commercialize 2nd generation route. Managing external vendors for API production to meet clinical needs; working with other… Show more API (DS) lead for AT-752, a clinical candidate for anti-viral applications. Responsible for process R&D; delivery of API to meet clinical needs; providing supporting documents for regulatory filing. Managing external vendors for process research and development; providing scientific and technical guidance; developing a practical, free-to-operate, and ready to commercialize 2nd generation route. Managing external vendors for API production to meet clinical needs; working with other functions(QA/QC) to ensure delivery on time. Working on Late-Stage Process Development for AT-527, an oral anti-viral drug targeted for COVID-19; solved critical scale-up problems and developed 2nd generation route. Supervising CMO to prepare radiolabelled API for clinical studies; Managing external CMO to prepare all labelled compounds for clinical studies; Establishing CDA, MSA; drafting technical transfer package and RFP; drafting segments for filing. Responsible fro evaluating process safety for all productions at CMOs. Show less



Corbus Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Principal Scientist, Pharmaceutical Development and Manufacturing (Virtual Setting)

  • Jul 2019 - Oct 2020

  Norwood, MA API (DS) lead to develop a new molecule (CRB-4001) for clinical investigation (tox, phase 1) ; Selecting CROs and CMOs for RSMs and API development and manufacturing; Setting up CDAs and MSAs with vendors; Defining Scope of Work and requesting RFPs; prepare change orders as needed. Working with project management to prepare budget and timeline; Supervising CROs and CMOs for developing phase-appropriate tasks and manufacturing activities by teleconferences and on-site visits.;… Show more API (DS) lead to develop a new molecule (CRB-4001) for clinical investigation (tox, phase 1) ; Selecting CROs and CMOs for RSMs and API development and manufacturing; Setting up CDAs and MSAs with vendors; Defining Scope of Work and requesting RFPs; prepare change orders as needed. Working with project management to prepare budget and timeline; Supervising CROs and CMOs for developing phase-appropriate tasks and manufacturing activities by teleconferences and on-site visits.; solving critical issues in manufacturing. Transfer process to different CMO with large capacity for late stage demand. Optimized process for larger scale (100kg+)production. Drafting technical documents and regulatory filing documents (IB, IND); Working with other functions to move the program forward. Show less



TESARO, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Manager, Late-Stage Chemical Development (Virtual Setting)

  • May 2017 - Jun 2019

  Waltham, Massachusetts Worked on Late-Stage process development for Niraparib (ZEJULA®); an anti-ovarian cancer drug. Drifted and reviewed CMC documents for Process Validation and NDA/MAA filing; Performed Technical Transfer to CMOs (2nd and 3rd API suppliers) successfully; Performed API process validation for NDA Approval and supervised API production at CMO sites; Drafted SOW, Requested RFP, and supervised Phase III development activities at CRO site; Managing API genealogy and support supply chain… Show more Worked on Late-Stage process development for Niraparib (ZEJULA®); an anti-ovarian cancer drug. Drifted and reviewed CMC documents for Process Validation and NDA/MAA filing; Performed Technical Transfer to CMOs (2nd and 3rd API suppliers) successfully; Performed API process validation for NDA Approval and supervised API production at CMO sites; Drafted SOW, Requested RFP, and supervised Phase III development activities at CRO site; Managing API genealogy and support supply chain to meet API needs. Support commercial manufacturing after NDA approval. Show less



Cubist Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Senior Staff Scientist

  • Feb 2015 - Dec 2016

  Lexington, MA Process research and development for 2nd generation Ceftolozane (Zerbaxa®); Process characterization studies, such as range selection and robustness using Design of Experiment (DoE) approach (late stage activity); Impurity fate study and specification defining using spiking and purging approach (late stage activity); Process research and scale-up of a new small molecule API from medicinal route (early stage activity).



Synta Pharmaceuticals

• Senior Scientist Process Chemistry (lab, hands-on)

  • Aug 2011 - Jun 2014

  Lexington, MA Optimized a medicinal route to make it ready for Tox and first GMP batch production; Performed Late-Stage activities (spike and purge, robustness, range, etc.) for Process Validation; Prepared source documents for NDA filing; On-site visit and support production at CMO site.



GTx, Incorporated

• Senior Scientist: Process Chemistry

  • Jun 2008 - Mar 2011

  Memphis, TN Responsible for Process Chemistry and API manufacturing (first process chemist on board) •Worked on prostate cancer research area (SERM and SARM). •Evaluated and improved synthesis routes for pre-clinical small molecule drug candidates; •Develop robust process chemistry for the production of API (GTX-758) at CMO to support preclinical and Phase 1/2 clinical studies; •Improved the overall yield of GTX-758 project from 20% to >50% and carried the project from Tox to Phase II… Show more Responsible for Process Chemistry and API manufacturing (first process chemist on board) •Worked on prostate cancer research area (SERM and SARM). •Evaluated and improved synthesis routes for pre-clinical small molecule drug candidates; •Develop robust process chemistry for the production of API (GTX-758) at CMO to support preclinical and Phase 1/2 clinical studies; •Improved the overall yield of GTX-758 project from 20% to >50% and carried the project from Tox to Phase II successfully; •Identified and selected CMO for large scale manufacturing; •Coordinated and overseen technology transfer and GMP production for APIs; •Using knowledge from various disciplines to trouble-shoot synthesis hurdles and impurity profile issues in API; •Worked with other functions to move the program forward; •Participated medicinal chemistry discussions and offered suggestions to improve organic synthesis. Show less



AMRI, Large Production Site (Organichem)

• Senior Scientist, Analytical Quality Service for API manufacturing

  • Mar 2005 - Mar 2008

  Rensselaer, New York •Analytical lead for one generic API project; •Method Development and Validation (GC and HPLC); •Performed IPC testing and Release testing for production; •Participated Batch Record review for GMP production and signed off as Analytical Function. •Performed various tests (mass balance, impurity identification, etc.) to support manufacturing. •Joined a team (analytical, process chemistry, engineering) to develop an isolation process for 3rd generation of Taxol®for Phyton… Show more •Analytical lead for one generic API project; •Method Development and Validation (GC and HPLC); •Performed IPC testing and Release testing for production; •Participated Batch Record review for GMP production and signed off as Analytical Function. •Performed various tests (mass balance, impurity identification, etc.) to support manufacturing. •Joined a team (analytical, process chemistry, engineering) to develop an isolation process for 3rd generation of Taxol®for Phyton Biotech. Enable to produce API-grade paclitaxel on a large scale. Show less



Curia

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Scientist, Process Chemistry and Combinatorial Chemistry

  • Mar 2001 - Feb 2005

  Albany, New York •Scaled up various small molecules for preclinical studies at fast pace; •Lead contract scientist for Millenium Pharmaceuticals, Inc.; Synthesis of metabolites of anti-cancer drug Velcade® (2003); Developed new synthetic method to solve synthetic hurdles; •FTE process scientist for a small biotech company; route optimization to improve yield to >90% for each step; screening crystallization solvents and make the process ready for pilot plant production; •FTE process scientist for a… Show more •Scaled up various small molecules for preclinical studies at fast pace; •Lead contract scientist for Millenium Pharmaceuticals, Inc.; Synthesis of metabolites of anti-cancer drug Velcade® (2003); Developed new synthetic method to solve synthetic hurdles; •FTE process scientist for a small biotech company; route optimization to improve yield to >90% for each step; screening crystallization solvents and make the process ready for pilot plant production; •FTE process scientist for a small biotech company; large scale intermediates synthesis; Improve process and procedures; solved critical synthetic issues; increase output from 200g/month to 200g/week; •FTE scientist for a large pharmaceutical company; large scale multi-step intermediate and scaffold synthesis; Scaled-up a 7-step route to 100g-scale with elimination of costly and dangerous reagents and improved overall yield 3-fold; •Acquired combinatorial techniques and synthesized analogs for various biotech and Argo companies. •Designed new strategy to synthesize targets that were not attainable by previous methods. Show less



Florida State University

• United States
• Higher Education
• 700 & Above Employee

• Postdoc Associate, Process Research

  • Aug 1998 - Feb 2001

  Tallahassee, Florida •Process research of various beta-lactams used for Paclitaxel analog synthesis; •Improve medicinal route to pilot plant ready route; Eliminate column chromatography usage; •Structural elucidation of Paclitaxel analogs and impurities using various NMR techniques; •Synthetic method development and participated in total synthesis of Lonomycin;