PING CARLSON
Oxford,NJ
Summary
Possess strong technical expertise and leadership skills in analytical and bioassay development to support pharmaceutical CMC and Quality Control for Antibodies, Fusion Proteins, ADCs and Gene Therapy products. Demonstrated proficiency in engaging with regulatory bodies and effectively managing projects.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Senior Director of Analytical Development & Quality Control
Passage Bio
09.2021 - 01.2025
- Prepared detailed briefing books for regulatory Type C/D meetings, focusing on functional potency related MOAs.
- Discovered biomarker-related cell signaling pathways and developed functional potency assays to support late-stage AAV product manufacturing.
- Heavily involved in process comparability studies, CQA assessments, and analytical specification settings across multiple programs.
- Oversaw process, analytical, stability, and budgeting activities for various programs.
- Proven project management skills through new project proposals, from planning, execution to deliverables, ensuring alignment with objectives and timelines.
- Authored and reviewed bioanalytical method and validation sections for IND applications.
- Designed robust potency assay strategies and strategic plans for reference standards, assay controls, and critical reagent management.
- Led a team to successfully qualify and transfer four bioassays to cGMP labs within one year.
Associate Director, Bioassay
Bristol Myers Squibb
06.2018 - 08.2021
- Managed a team of 12 across two sites, overseeing the development and validation of bioassay methods for lot release.
- Oversaw 13 programs, including biologics and an AAV-GT product, managing both in-house analytical development and CROs for cGMP lot release.
- Drafted and reviewed responses to health authority inquiries.
- Served as the bioanalytical lead for new pipeline programs, supporting IND submissions and participating in CMC and project meetings for key decision-making.
- Contributed to BLA filing activities by authoring source documents and participating in the review process.
Group Leader, cGMP Bioassay, Late Phase
Eli Lilly and Company
02.2007 - 05.2018
- Led method validation and supported BLA submission while preparing the team for PAI; played a key role in bioanalytical characterization to support PMC.
- Supported global bioassay transfer and harmonization, establishing a control strategy for reference standards, assay controls, and critical reagents.
- Led bioassay efforts in CMC development for various immuno-oncology monoclonal antibodies (mAbs), overseeing process development, comparability support, outsourcing, tech transfer, and method bridging.
- Conducted stress studies and developed bioanalytical methods to assess critical quality attributes (CQA) of mAbs.
Introduced an innovative cryopreserved ready-to-use cell format for cell assays.
Education
M.D. - Medicine
Harbin Medical University
ChinaPh.D. - Biochemistry
University of Tokushima
JapanSkills
- Bioassay Development: Extensive expertise in cGMP bioassay development for biologics and gene therapy
- Regulatory Knowledge: Proficient in authoring sections for IND and BLA submissions, as well as drafting briefing books for type C/D meetings
- Project Management: Strong skills in managing multiple programs and leading teams towards successful project outcomes
- Process Comparability and CQA assessment: Experience in utilizing potency and analytical methods for product characterization supporting process and product CQAs
- Statistical Analysis: Skilled in DOE, statistical data analysis, and data trending for method lifecycle management Proficient in Equivalence testing for establishing comparability acceptance criteria
- Quality Control: In-depth experience in QC lot release, stability trending, and root cause analysis for deviations
- Method Validation and Technical Transfer: Proven ability to lead method validation activities and oversee tech transfer of bioassays between sites
- Method Lifecycle Management: Developed strategies for assay reference, assay control and critical reagent management to ensure life-time performance
- Leadership: Experience in leading teams and fostering collaboration across multiple sites and projects
- Education & Certification: PhD in Biochemistry, MD in Medicine, with certifications in Statistics
Certification
- Completed 35 contact hours for PMP Exam (March 2025)
- Three statistics courses and certificates (August 2019)
- JMP advanced user courses by SAS (May 2019)
Affiliations
- BioPhorum Biologics and CGT
External Presentations
- 2nd Gene Therapy Potency Assay Summit, 07/01/24
- CASSS CGTP Symposium, Viral Vector Session, 06/01/24
- The 15th Annual Bioprocessing Summit (Stream #3, Gene Therapy), 08/01/23
Patents
- POTENCY ASSAY OF PROGRANULIN, U.S. Provisional Patent Application No. 63/656,588, 06/05/24, Carlson P, Patil A, Matamoros A, Liu H, Singh N, Fucci E, Rank L
- ACTRIIB LIGAND TRAP COMPOSITIONS AND USES THEREOF, PCT# 17/519,305, 11/04/21, Varghese J, Mahon D, Madayiputhiya N, Carey K, Mahndirattha P, Carlson P, Boregowda R
Publications
- A Phase-Appropriate Approach To Assay Validation, BioPhorum CGT Sub-teams, 01/17/24, https://www.biophorum.com/download/phase-appropriate-approach-to-assay-validation/
- Conformational characterization of the charge variants of a human IgG1 monoclonal antibody using H/D exchange mass spectrometry. MAbs. 2013, 5 (1): 114-125. Tang L, Sundaram S, Zhang J, Carlson P, Matathia A, Parekh B, Zhou Q, Hsieh MC
- Differential regulation of macropinocytosis by Abi1/Hssh3bp1isoforms, PLoS One, 2010, 5, 5, e10430, Dubielecka PM, Cui P, Xiong X, Hossain S, Heck S, Angelov L, Kotula L
- Allosteric inhibition of the nonMyristoylated c-Abl tyrosine kinase by phosphopeptides derived from Abi1/Hssh3bp1, Biochim Biophys Acta, 2008, 1783, 5, 737-47, Xiong X, Cui P, Hossain S, Xu R, Warner B, Guo X, An X, Debnath AK, Cowburn D, Kotula L
- Nuclear localization of the phosphatidylserine receptor protein via multiple nuclear localization signals, Exp Cell Res, 2004, 293, 1, 154-63, Cui P, Qin B, Liu N, Pan G, Pei D
- Endothelin-1 peptides and IL-5 synergistically increase the expression of IL-13 in eosinophils, Biochem Biophys Res Commun, 2004, 315, 4, 782-7, Cui P, Sharmin S, Okumura Y, Yamada H, Yano M, Mizuno D, Kido H
- Binding of a new bioactive 31-amino-acid endothelin-1 to an endothelin ET(B) or ET(B)-like receptor in porcine lungs, Eur J Pharmacol, 2003, 465, 1-2, 31-8, Kitamura H, Cui P, Sharmin S, Yano M, Kido H
- A novel bioactive 31-amino acid endothelin-1 is a potent chemotactic peptide for human neutrophils and monocytes, J Leukoc Biol, 2001, 70, 2, 306-12, Cui P, Tani K, Kitamura H, Okumura Y, Yano M, Inui D, Tamaki T, Sone, Kido H
Timeline
Senior Director of Analytical Development & Quality Control
Passage Bio
09.2021 - 01.2025
Associate Director, Bioassay
Bristol Myers Squibb
06.2018 - 08.2021
Group Leader, cGMP Bioassay, Late Phase
Eli Lilly and Company
02.2007 - 05.2018
M.D. - Medicine
Harbin Medical University
Ph.D. - Biochemistry
University of Tokushima
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