Experience

Tanvex Biopharma USA, Inc

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Director of BioProcess Development

  • Apr 2019 - Nov 2023

  San Diego, California, United States Provided leadership and direction to process development team - overseeing cell line development, mammalian cell culture and microbial fermentation, purification process development for own pipeline and CDMO clients and providing support to the management team. • Led the team in developing robust cell culture and fermentation processes, bioreactor scale up and tech transfer, batch record review, supported GMP production from early clinical production to late stage process… Show more Provided leadership and direction to process development team - overseeing cell line development, mammalian cell culture and microbial fermentation, purification process development for own pipeline and CDMO clients and providing support to the management team. • Led the team in developing robust cell culture and fermentation processes, bioreactor scale up and tech transfer, batch record review, supported GMP production from early clinical production to late stage process validation. • Led comprehensive process characterization, including process parameter risk analysis, scale down model qualification, robustness study design, CPP, CQA and in-process control development and PPQ protocol review. • Effectively collaborated with cross-functional teams, including purification, analytical, quality, regulatory affairs, MSAT and manufacturing to advance multiple projects from early stage to late stage development and BLA submission. • Supported regulatory filings, including drafting drug substance CMC upstream sections, preparing for FDA pre-license inspections and responding to FDA review questions. • Effectively built and developed a high performing cell culture team. • Mentored a Sr. Scientist to establish new cell line development capability to provide CDMO services.

• Director, Cell Culture

  • Apr 2015 - Apr 2019

  San Diego, California, United States Leading cell culture process development for biologics and providing support to the management team

• Group Lead, Cell Culture

  • Aug 2014 - Apr 2015

  San Diego, California, United States Building cell culture development team and leading cell culture process development for biologics

• Senior Scientist

  • Mar 2014 - Aug 2014

  San Diego, California, United States



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr. Development Scientist

  • Jul 2011 - Feb 2014

  Greater San Diego Area Key leader in establishing a new Biotherapeutics Development Unit, overseeing upstream process development and non-GMP DS/DP production for GLP toxicological studies, including strategic planning, budgeting, designing, execution and cross-functional coordination. • Drove upstream lab setup, including floor plan design, equipment lay-out, utility requirements for glass washing and autoclaving, media preparation, bench scale and pilot scale bioreactors, budgeting, procurement, installation and… Show more Key leader in establishing a new Biotherapeutics Development Unit, overseeing upstream process development and non-GMP DS/DP production for GLP toxicological studies, including strategic planning, budgeting, designing, execution and cross-functional coordination. • Drove upstream lab setup, including floor plan design, equipment lay-out, utility requirements for glass washing and autoclaving, media preparation, bench scale and pilot scale bioreactors, budgeting, procurement, installation and testing. Saved hundreds of thousands of dollars on the budget through vendor negotiation. • Ensured all the equipment met the short term and long term needs and with full consideration for future capability improvement based upon in-depth research. • Established a fully functional cell line development and cell culture lab, optimizing cell culture process in single use bioreactor (SUB) and aligning processes with Novartis TRD-Biologics in Basel, Switzerland. • Provided technical advice across projects and represented upstream on CMC team. Show less



Biogen

• United States
• Biotechnology Research
• 700 & Above Employee

• Scientist II

  • Jun 2004 - Apr 2011

  San Diego, California, United States Led cell culture development projects, process optimization, technology implementation, technology/process transfer and supported manufacturing, including cGMP cell banking, investigation, data analysis. and representation on CMC teams. • Developed perfusion-based high density cell banking technology. Accomplished implementation of the high density cell bank in manufacturing therapeutic proteins from CHO cells. This technology significantly increases the manufacturing throughput and saves… Show more Led cell culture development projects, process optimization, technology implementation, technology/process transfer and supported manufacturing, including cGMP cell banking, investigation, data analysis. and representation on CMC teams. • Developed perfusion-based high density cell banking technology. Accomplished implementation of the high density cell bank in manufacturing therapeutic proteins from CHO cells. This technology significantly increases the manufacturing throughput and saves several million dollars per campaign. Recognized in Pharmaceutical Operations & Technology 2009 Q1 report. • Overcame technical challenges and improved seed train culture expansion for a commercial program • Contributed to CHO platform technology development, cycle 1 project process development and fed batch optimization. • Managed cycle II project pre-development activities • Coordinated with cross-functional team members to support phase III re-supply campaign: identified issues, evaluated process adjustment for new facility fit and developed solutions • Evaluated new technology in enhancing recombinant protein production through collaboration with external innovators • Authored process development reports, PFD and GMP documents. Reviewed and approved batch records • Engage, inspire and develop direct reports Show less



Bayer

• Chemical Manufacturing
• 700 & Above Employee

• Scientist

  • 1997 - 2004

  • Managed and completed many projects from the initial literature searches to the final report generation. Generated master cell bank candidate for a protein therapeutic production with 2-fold improvements in productivity using molecular chaperones. Achieved the goal one month ahead of the projected timeline. Advanced the product to clinical development and earned the Bayer Scientific Achievement Award. • Effectively collaborated with protein analytical, purification and fermentation… Show more • Managed and completed many projects from the initial literature searches to the final report generation. Generated master cell bank candidate for a protein therapeutic production with 2-fold improvements in productivity using molecular chaperones. Achieved the goal one month ahead of the projected timeline. Advanced the product to clinical development and earned the Bayer Scientific Achievement Award. • Effectively collaborated with protein analytical, purification and fermentation departments. Developed high producing cell lines for fed batch fermentation process within one year. Evaluated clones in small scale to 200-L bioreactor in a timely manner and provided recommendations for final clone selection. Delivered reproducible data for process transfer. • Improved process efficiency. Established one-step scale-up process for the inoculation of 200-L bioreactor. Shortened the standard process of 4-6 weeks to 3 weeks from thawing a vial to inoculation. Simplified the process and reduced workload 50%. Received the Bayer Special Recognition Award. • Applied versatile expression system and produced gram-scale human monoclonal antibodies in mammalian cells in less than two months. Purified 2.8 gram antibody from 300-L bioreactor harvest. • Utilizing highly effective planning successfully performed a genetic stability characterization study under a tight timeline to support the license application for a 200-liter bioreactor production of Kogenate (rFVIII). • Supported Kogenate re-engineering activities: new cell bank evaluation and down-regulation of a host cell protein in a candidate clone by anti-sense RNA. • Studied the roles of disulfide bonds in folding, secretion and expression of a recombinant protein in mammalian cells by site-directed mutagenesis. Show less