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PROFESSIONAL SUMMARY• Over 20 years’ experience of analytical method development, qualification/validation, assay transfer internally / externally / globally, in support of process development and clinical manufacturing for IND/BLA filings of biopharmaceutical therapeutics (mAb, Fab, Fusion proteins, Bi/Trispecific mAbs, cytokines, Pegylated Proteins, Plasmid DNA, Peptides) & adeno-associated virus (AAV) gene therapy products: including in-process, release and stability testing, protein characterization/comparability studies. • Led process development analytics (PDA) in support of Cell line development/Clone Selection, Upstream & Downstream process development, Drug Product/Formulation development and clinical manufacturing for over 40 programs of various biopharmaceutical drug candidates from clinical development through registration (Tox, Phase I-III). • Established and built best-in-class internal analytical labs (analytical development, bioassay development, in-process analytical support and QC).• Clinical lot release, raw material release, critical reagent control, stability programs, data trending, Reference Standard qualification. Specification setting, comparability, and Analytical strategy for early, late and commercial products, QbD risk assessments, GMP compliance, OOS, investigation, and deviation.• Extensive hands-on expertise and trouble-shooting skills in separation science and mass spectroscopy, including RP-HPLC, Titer, CE-SDS/Caliper GX II, SEC, iCIEF/CEX, N-glycans, Amino Acids Analysis, PS 80 & 20 testing etc. Protein characterizations, intact mass analysis, peptide mapping and post-translational modification (PTM) determination, glycosylation site and carbohydrate structure elucidation and analysis, deamidation and oxidation, etc. • Extensive expertise with ELISA, qPCR, and Automation for high throughput process related impurities (HCPs, rDNA, rPro A, etc.) determination. • Proven tracking record of accomplishments for building analytical capabilities, serving as SME on aspects of analytical method development /qualification/ validation/ technology transfer, and process development analytics support in a team based non-GMP and GMP environment. • Authored/reviewed analytical sections for INDs, BLAs, and post marketing commitments.• Extensive outsourcing experience with CMO’s and CRO’s. Responsible for vendor selection, contract initiation and approval, technical review of quality agreements to support analytical/ QC testing.• Excellent team building skills along with a strong aptitude to work with cross-functional teams.
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DirectorPrimera Analytical Solutions Corporation Nov 2023 - Aug 2024Princeton, New Jersey, Us -
Associate Scientific DirectorBristol Myers Squibb Dec 2020 - Oct 2023• Led analytical support for cell line, upstream/downstream development.• Established and managed GMP in-process testing to support clinical manufacturing for mAbs, Bispecific mAbs, Fab & pDNA for CAR-T and AAV programs.• Developed & Qualified in-process and release methods to support clinical manufacturing, DS & DP release and stability studies.• Managed Phase Appropriate Qualification/Validation & Tech Transfer of methods to CRO/CMOs • Reviewed and approved clinical manufacturing sample and testing plans for batch records.• Reviewed and approved quality control testing results for raw materials, in-process and final finishing Drug Substance products. • Developed laboratory maintenance program for QC lab to assure that all systems were within cGMP compliance and regulatory requirements.• Conducted and reviewed product and/or lot-related deviations, change controls, and annual quality reviews.• Worked closely with QA and clinical manufacturing to address internal audits related CAPAs.• Led PDA team to perform in-process, release and stability testing for Tox DS and DP as well as characterization, stress and comparability studies for IND submission.• Served as Project Development Analytic Lead (PDAL) for several programs. Collaborated with Cell Line development, upstream and downstream process development leads to drive the project development through Tox to Ph III. Developed strategies and ensured that process scale-up and technical transfer of early and late-stage of biological manufacturing processes to pilot and cGMP manufacturing facilities for biological molecules expressed in various expression systems meet the project timelines.• Established assay support for AAV projects: including titer, AEX, ELISA, ddPCR.• Validation and implementation of Empower, LIMS & ELN systems for GMP and Non-GMP use.• Authored and reviewed technical documents for IND and BLA filings.
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Senior Principal ScientistCelgene/Bms Sep 2014 - Dec 2020Play critical roles to build Celgene internal biologics development & Manufacturing capabilities from scratch. Established and led process development analytics (PDA) team for biologics analytical testing strategy for cell line/clone selection, upstream, downstream and drug product development and stability studies for programs including Fusion Proteins, mAbs, Bi/Tri Specific mAbs, ADCs, Fab proteins.Established and Managed Celgene onsite Insourced FTE program for biologic development. Established platform methods for Intact Mass analysis, Peptide Mapping and Carbohydrate structure elucidation assays to support clone selection, protein characterization and comparability studies. Served as and Mentor Analytical Team Leaders (ATL) for projects, developed analytical strategy for release, specification, and stability testing. Authored and reviewed the analytical sections for IND submission. Portfolio management, prioritization, resource planning, budgeting & risk assessment and mitigation in a rapidly evolving landscape geared towards fast to FIH.• Support REBLOZYL® (Luspatecept) BLA submission. In sourced assays from CRO and provided analytical testing to support process characterization, comparability studies for Celgene’s first commercial biologic REBLOZYL® (luspatercept) BLA submission.Outsourcing assays and oversaw method development, qualification, and testing for lot release and process characterization.Established sample management for Luspatecept and managed over 3000 samples shipment in and out of CRO/CMO/Celgene to support testing and BLA filing.Authored and reviewed BLA associated technical reports and responses to questions. Collaborated with cross-functional teams to address PAI questions by providing technical reports and responses to questions.
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Sr. Research Investigator IiBristol-Myers Squibb Co Jan 2006 - Sep 2014Lawrence Township, Nj, Us• Provided analytical support for Nivolumab® (PD-1) process C development and process validation for BLA filing. Reviewed protocols, validation reports for in-process, and impurity testing from CDMO/CROs. • Built and led Process Development Analytics group to provide analytical support for Clone Selection, upstream and downstream process development and in-process testing for Tox/FIH clinical manufacturing for mAbs/Fusion Fab-Peg Proteins to build biologic pipelines. Delivered technical reports for mAb characterization, authored/reviewed analytic sections for IND submissions of pipeline products.Served as SME to review/approve extractable and leachable protocols and testing reports from CRO to support BMS projects, including Abatacept (Orencia®), Belatacept (Nulojix®), and Ipilimumab (Yervoy®). Developed & implemented high throughput automation technology to improve efficiency.Served as SME and collaborated with cross-functional teams for belatacept (Nulojix®) carbohydrate related FDA response for comparability and post-marketing commitments.Led characterization method development and delivered BLA filing related technical reports for Ipilimumab (Yervoy®) characterization, forced degradation and comparability studies, Set up CQA and control strategists. Wrote/reviewed technical reports and authored analytical sections for BLA filing.Led a group of scientists to provide analytical support for process B and process C comparability studies and wrote technical/result summary reports.Provided technique expertise to regulatory responses according to timelines to support ipilimumab BLA submission. Built and led a group of scientists to provide carbohydrate characterization and Monosaccharides, Sialic Acids, and N-Linked Profile release testing for belatacept (Nulojix®). -
Principle ScientistSchering-Plough Research Institute/Merck Sep 1997 - Dec 200510/2003-12/2005 Principle ScientistSupport mAbs process development and other biopharmaceuticals, including IFN, PEG-IFN, Viral Vectors (p53, p21 and Crav gene therapy) process and formulation development, stability and release testing.• Developed assays for Carbohydrate analysis using Dionex HP-PAD and LC/MS/MS in support of mAb characterization and comparability studies.• Developed peptide mapping method for determination of Glycosylation, Oxidation, Deamidation in support of mAb stability, characterization and comparability studies using LC/MS/MS.09/1999-09/2003 Associate Principle ScientistDevelop and qualify/validate various HPLC assays (including Reverse Phase, Normal Phase, Size Exclusion, Anion / Cation Exchange and Protein A Affinity) for IFN, PEG-IFN, Cholesterol, Amino Acids and mAb quantitation to support process development and in-process testing.• Developed carbohydrate analysis using Dionex and Beckman P/ACE MDQ for mAb characterization and comparability studies.• Developed cIEF methods for PEG-IFN and mAb using Beckman P/ACE MDQ system.• Developed automation immunoassay for mAb quantitation, identification and affinity studies using KinExA 3000 system.• Supervised HCP, residual DNA and residual protein A test using ELISA in support of mAb process development and TOX/FIH manufacture.09/1997-09/1999 Sr. Scientist• Provided analytical support for process development and in-process testing for various projects including: Interferon, Peg-IFN , monoclonal antibodies and Viral Vectors (p53, p21 and Crav gene therapy)• Qualified/Validated in-process methods for Titer, Isoform testing and transferred methods to Quality Control and Manufacturing site.
Mei Lin Skills
Mei Lin Education Details
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Beijing Normal UniversityBioanalytical Chemistry -
Beijing Normal UniversityChemistry
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Binghamton UniversityAnalytical Chemistry
Frequently Asked Questions about Mei Lin
What is Mei Lin's role at the current company?
Mei Lin's current role is Associate Scientific Director at BMS.
What is Mei Lin's email address?
Mei Lin's email address is ml****@****ene.com
What is Mei Lin's direct phone number?
Mei Lin's direct phone number is +190867*****
What schools did Mei Lin attend?
Mei Lin attended Beijing Normal University, Beijing Normal University, Binghamton University.
What skills is Mei Lin known for?
Mei Lin has skills like Pharmaceutical Industry, Drug Development, Biotechnology, Hplc, Assay Development, Biopharmaceuticals, Biomarkers, Lc Ms, Protein Chemistry, Analytical Chemistry, Technology Transfer, Elisa.
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