Experience

Altruist Biologics/夏尔巴生物

• China
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Director of Business Development, CMC Project Specialist

  • Aug 2023 - Present

  United States * mAb, fusion proteins, ADCs, and CGT - DS DP commercial batches, global filing experiences Altruist Bio, the largest commercial CDMO in China, a spinout from China's biggest biopharma, Innovent Biologics, leverages Innovent's commercial experience for the benefit of other global Parties. Focusing on the development and commercial manufacturing of biopharmaceuticals including antibodies, fusion proteins, ADCs, cell and gene therapies products, Altruist has helped our clients with 30+ INDs in… Show more * mAb, fusion proteins, ADCs, and CGT - DS DP commercial batches, global filing experiences Altruist Bio, the largest commercial CDMO in China, a spinout from China's biggest biopharma, Innovent Biologics, leverages Innovent's commercial experience for the benefit of other global Parties. Focusing on the development and commercial manufacturing of biopharmaceuticals including antibodies, fusion proteins, ADCs, cell and gene therapies products, Altruist has helped our clients with 30+ INDs in China, 10+ INDs in US, 3 INDs in Australia, 10 NDAs in China, 1 BLA in US, and 10+ post-approval changes. By the end of 2024, we will have over 230,000 Liter total capacity from 50 L to 20,000 L, and have been audited by the FDA, EMA, and NMPA as well as by big Pharma such as Eli Lilly. In addition, we have manufactured over 1500 commercial DS/DP batches and have delivered multiple clinical therapeutic biologics for programs in Europe, US, Australia, and APAC countries. Our range of services include the end-to-end development and manufacturing, from DNA sequence to Fill and Finish of the following: • Mammalian based biologics o Antibodies o Fusion proteins o Multi-specifics o Other recombinant proteins • ADCs • Cell and Gene Therapy products o Plasmid Production o Lentivirus production o CAR-T manufacturing Skills: ADCs · Biologics Manufacturing · Aseptic Fill & Finish · Cell & Gene Therapy Manufacturing · Commercialization Show less



JanBio Consulting

• United Kingdom
• Retail Office Equipment

• Principal Consultant

  • Oct 2022 - Present

  San Diego, California, United States Drug development projects, R&D / pre-IND through commercial filing, cross-functional global project management and leadership, CMC regulatory submission, CDMO / CRO evaluation and management



I-Mab Biopharma

• China
• Biotechnology
• 1 - 100 Employee

• Associate Director, CMC Project Management

  • Sep 2021 - Sep 2022

  San Diego, California, United States Roles: CMC project management / lead, CDMO / CRO / alliance management on early and late stage projects of biologics Led and integrated the CMC team in project gap analysis and risk assessment. Managed the communication and negotiation with CDMOs (business development) and external alliance partners. Drove the decision making of risk-based project strategies with risk assessment and scenario analysis. Planned Ph3 late stage process characterization and process validation (PC/PV)… Show more Roles: CMC project management / lead, CDMO / CRO / alliance management on early and late stage projects of biologics Led and integrated the CMC team in project gap analysis and risk assessment. Managed the communication and negotiation with CDMOs (business development) and external alliance partners. Drove the decision making of risk-based project strategies with risk assessment and scenario analysis. Planned Ph3 late stage process characterization and process validation (PC/PV) project activities and aggressive timelines for BLA filing with CDMO/CRO. Managed CDMO / CRO for all late stage Ph3 CMC PC / PV activities, including contract work scopes / costs evaluation / negotiation, GMP and non-GMP project deliverables and timelines, risk planning and mitigation for expected / unexpected events, internal and external project management, and team management / development. Integrated internal cross-functional communications (clinical, non-clinical, regulatory, R&D, CMC, and management team) and streamlined business / procurement / finance / legal functions for effective contract / budget reviewing / approval processes. Show less



Genentech

• United States
• Biotechnology Research
• 700 & Above Employee

• CMC Project Manager, Pharma Technical Development

  • Jul 2020 - Sep 2021

  San Francisco Bay Area Role: CMC Technical Development Project Manager for multiple projects in gRED pipeline. Led multiple global technical development teams of small molecules, from pre-IND through early phases of CMC development. CMC strategy development, budget and resource forecasting, timelines on (near) critical paths, CMO management, CMC risk assessment, and tracking technical development milestones. Contributed to making project strategies in Core Team, aligned all CMC activities to the… Show more Role: CMC Technical Development Project Manager for multiple projects in gRED pipeline. Led multiple global technical development teams of small molecules, from pre-IND through early phases of CMC development. CMC strategy development, budget and resource forecasting, timelines on (near) critical paths, CMO management, CMC risk assessment, and tracking technical development milestones. Contributed to making project strategies in Core Team, aligned all CMC activities to the clinical development plans, and facilitated team discussions, through strong partnership with CMC technical leaders. Directed highly complex project communications (in all channels) and ensured stakeholders are informed of project activities and status at the right level of contents. Integrated cross-functional CMC teams, empowered team members, held accountabilities, and developed teams through trust, appreciation, and mentorship. Show less



Spectra Bio Labs

• United States
• Biotechnology Research
• 1 - 100 Employee

• Project Management Consultant

  • Jan 2020 - Jul 2020

  Greater San Diego Area Role: Project management and business development for product / process development activities at research and pre-IND stages in a startup CDMO.



Halozyme Therapeutics, Inc.

• Research Scientist, Product Development

  • Jan 2017 - Jan 2020

  Greater San Diego Area Role: Led scientific projects for the development of formulations, analytical methods, and manufacturing process using QbD approach. Managed CMC activities and authored regulatory documents. Project Management / Leadership •Demonstrated the leadership by influencing the cross-functional CMC team without formal authority for the implementation of QbD. •Led projects of in-use compatibility studies of medical devices for Phase III global clinical trials and BLA filing to… Show more Role: Led scientific projects for the development of formulations, analytical methods, and manufacturing process using QbD approach. Managed CMC activities and authored regulatory documents. Project Management / Leadership •Demonstrated the leadership by influencing the cross-functional CMC team without formal authority for the implementation of QbD. •Led projects of in-use compatibility studies of medical devices for Phase III global clinical trials and BLA filing to allow flexibility in clinical operations, emphasizing critical path method and risk analysis. •Managed CMO / CRO for analytical methods, characterizations of DS / DP, microbial in-use study, extractable / leachable, elemental impurities, fill-finishing activities, and PK / PD / Tox studies, to meet regulatory requirements. •Managed alliance partnership for co-formulation and analytical method development (DoE), specification setting, statistical process control, stability data analysis, and phase-specific CMC strategies. •Collaborated with CMC sub teams on risk assessments for QTPP, CQA, CPP, CMA, method and technology transfer to CRO / CMO, and OOS troubleshooting and problem solving. CMC / Regulatory •Represented Product Development in the cross-functional CMC core team and worked closely with the CMC lead, to develop appropriate regulatory strategies (QbD) and manage CMC activities at CDMO. •Authored and reviewed CMC sections (Module 3) in IND / IMPD amendments and BLA / MAA filings for changing manufacturing process, formulations, analytical methods, and product specifications. •Led projects of comparability studies to support CMC changes in processes, formulations, and analytical methods at various scales and GMP sites. •Anticipated and responded to global agencies’ queries and helped prepare Type C meeting briefing books. •Managed team communication vertically and horizontally through presentations across the organization.

• Senior Research Associate II

  • Jan 2014 - Dec 2016

  Greater San Diego Area CMC / Regulatory •Provided cross-functional technical and product quality support (CQAs, CPPs, CMAs) including stability data monitoring / trending, OOS investigation, and the release of consistent batches of phase I / II / III clinical trial material and process performance qualification (PPQ) lots for commercial use, through close working relationships with QA, QC, Manufacturing, and CDMO / CRO (GMP). •Championed statistical approaches for setting specifications, process… Show more CMC / Regulatory •Provided cross-functional technical and product quality support (CQAs, CPPs, CMAs) including stability data monitoring / trending, OOS investigation, and the release of consistent batches of phase I / II / III clinical trial material and process performance qualification (PPQ) lots for commercial use, through close working relationships with QA, QC, Manufacturing, and CDMO / CRO (GMP). •Championed statistical approaches for setting specifications, process control, method monitoring, shelf life analysis, method development and qualification. Formulation / Analytical / Process Development •Developed phase appropriate stable formulations for pre-clinical, phase I / II / III, and commercial use using DoE. Designed phase appropriate excipient screening and stability studies. •Designed and optimized critical analytical methods (HPLC, SEC-MALS, LC/MS, sub-visible particles) and enzymatic potency assays by using DoE to cover multiple CQA and supported method qualification and method transfer. •Established a robust and scalable conjugation process for drug substance (using DoE) and supported successful tech transfer. •Proactively introduced updated industrial knowledge and new analytical techniques to provide scientific solutions and close gaps. •Technical skills: Microsoft Project, JMP (DoE, statistical analysis, process / method control), HPLC (SEC, RP, IEX), SEC-MALS, DLS / SLS, CD, FT-IR, UV-Vis, SDS-PAGE, NMR, LC-MS, cIEF, CE, FlowCam, MFI, HIAC, Horizon, rheology, TFF, enzymatic potency assay, molecular cloning, peptide synthesis

• Senior Research Associate I

  • Oct 2009 - Dec 2013

  Greater San Diego Area



Sangart, Inc.

• United States
• Furniture and Home Furnishings Manufacturing

• Research Associate II, Pharmaceutical Research and Development

  • 2007 - 2009

  Role: Designed and executed studies to generate, characterize, and develop PEGylated Biotherapeutics. Developed ambient stable PEGylated proteins using PEG-protein conjugation chemistry on hemoglobin, in oxy-, deoxy-, and CO- forms, to support phase I / II / III clinical trials. Designed and performed experiments for setting product specifications preventing any batch from failing during phase III clinical trials and product registration. Developed analytical methods… Show more Role: Designed and executed studies to generate, characterize, and develop PEGylated Biotherapeutics. Developed ambient stable PEGylated proteins using PEG-protein conjugation chemistry on hemoglobin, in oxy-, deoxy-, and CO- forms, to support phase I / II / III clinical trials. Designed and performed experiments for setting product specifications preventing any batch from failing during phase III clinical trials and product registration. Developed analytical methods resolving issues regarding to protein characterization and specifications for multiple CQAs to meet regulatory requirements. Provided cross-functional support and method / process transfer to non-clinical, analytical development, process development, quality control, CRO and internal GMP manufacturing. Technical skills: HPLC / FPLC (SEC, RP, IEX), DLS / SLS, CD, NMR, LC-MS, UV-Vis, CE, SDS-PAGE, densitometry, viscometry, and TFF Show less



Sangart

• Spain
• Construction
• 1 - 100 Employee

• Research Asssociate I

  • 2006 - 2007

  Greater San Diego Area



University of California at San Diego

• United States
• Hospitals and Health Care
• 1 - 100 Employee

• Research Positions in Academics

  • 2006 - 2006

  Graduate Program Researcher – under Murray Goodman, Ph.D. Protein expression, purification, and characterization of Type III secreted pathogenic protein MAP by X-ray crystallography. Peptide biophysical structure characterization of potent opioid peptidomimetic drug and their GPCR receptors by 2D NMR and molecular modeling. Research Assistant – under Sunney I. Chan, Ph.D. Institute of Chemistry, Academia Sinica, Taiwan Peptide chemistry: de novo synthesis of… Show more Graduate Program Researcher – under Murray Goodman, Ph.D. Protein expression, purification, and characterization of Type III secreted pathogenic protein MAP by X-ray crystallography. Peptide biophysical structure characterization of potent opioid peptidomimetic drug and their GPCR receptors by 2D NMR and molecular modeling. Research Assistant – under Sunney I. Chan, Ph.D. Institute of Chemistry, Academia Sinica, Taiwan Peptide chemistry: de novo synthesis of peptides conjugated with photolabile linkers for protein folding, biophysical characterization, and structure analysis using analytical chemistry techniques. Technical skills: HPLC, FPLC, LC-MS, UV-Vis, LS, NMR, CD, FTIR, SDS-PAGE, Western Blotting, cloning construction, site-directed mutagenesis, and solid-phase peptide synthesis. Show less