Haneesh Jasuja (Harry)
Chelmsford
Summary
PhD in Oncology with an approved patent and over 7 years of industrial experience across clinical manufacturing, external stakeholder engagement, medical communications, and analytical troubleshooting. Adept at translating technical and scientific concepts into actionable insights for healthcare professionals, clinical sites, and cross-functional teams, ensuring optimal patient experience and therapeutic outcomes. Deep understanding of CAR T-cell therapy, non-conforming product communication, and site readiness. Passionate about aligning medical affairs with manufacturing excellence to provide a positive first CAR T clinical experience.
Overview
12
12
years of professional experience
Work History
SCIENTIST III, VIRAL VECTOR SERVICES
Thermofisher Scientific
Plainville
04.2024 - 04.2025
- Collaborated effectively with the team to comprehend client-specific drug development frameworks and testing needs.
- Assessed gaps and potential risks in the client's analytical methods and proposed alternative approaches to mitigate the risks to Manufacturing.
- Managed project budgets by reviewing and updating Bill of Materials to meet company and stakeholder expectations.
- Managed several projects simultaneously, ensuring quality, on-time delivery, and useful insights for stakeholders.
- Tracked data trends to identify system deficiencies, promoting continuous improvements in analytical testing systems.
- Led data delivery to Manufacturing POC including release of comprehensive data reports and findings on inaccuracies.
- Ensured audit-readiness via GEMBA walks, supported internal and client audits.
- Collaborated closely with upstream and downstream teams, presented data to cross-functional teams, leveraging strong process knowledge to resolve issues and drive project progress.
- Authored development reports, tech transfer protocols, SOPs and trend reports.
SCIENTIST, CELL & GENE THERAPY
Sanofi
Waltham
10.2022 - 04.2024
- Led the development and successful transfer of analytical assays for NK cell product characterization into a cGMP-compliant Quality Control environment.
- Collaborated closely with QA and MSAT to ensure alignment on quality standards and timely deviation resolution.
- Facilitated the timely release of batches for clinical trial in adherence to stringent deadlines.
- Provided support to quality leadership during internal audits, ensuring deviation records are complete, traceable, and audit ready.
- Provided technical insights and resolving issues in day-to-day operations, confirming that drugs were tested in compliance with SOP and cGMP requirements.
- Led internal investigations, deviations, CAPA and RCA to support Manufacturing Operations. Presented project progress at cross-functional meetings and conferences.
- Collaborated with MS&T and QC teams to investigate and resolve OOS/OOT deviations, ensuring timely root cause identification and implementation of effective CAPAs.
- Performed risk-based impact assessments to evaluate the effect of method deviations and batch discrepancies on product release and stability programs.
- Utilized Operational Excellence tools (e.g., root cause analysis, fishbone diagrams, 5 Whys) to identify inefficiencies and implement continuous improvement initiatives across QC and CMC functions.
- Orchestrated comprehensive GxP training programs for Cell Therapy QC team, ensuring regulatory compliance and strengthening operational excellence.
PRINCIPAL SCIENTIST/TEAM LEAD BIOANALYTICAL TESTING
Eurofins PSS
Cambridge
01.2022 - 09.2022
- Managed a team of seven scientists (FTEs and contractors), overseeing goals, development, and performance reviews.
- Supervised and conducted testing of antibody-based drug products (biologics) to characterize post-translational protein modification using HILIC (glycan), SEC, CE (reduced and non-reduced), and compendial assays.
- Planned team assignments and organized technical resources to accomplish project activities within the time frame.
- Facilitated meetings with the external stakeholders to present results and report on performance metrics.
- Recruited new team members per client policies and facilitated comprehensive training on a range of assays.
DOCTORAL RESEARCH ASSISTANT
North Dakota State University
Fargo
08.2017 - 01.2022
- Collaborated with physicians and optimized techniques for breast cancer cell isolation from patient tissue, and validated an in-vitro disease model using qPCR, ELISA, and other cell-based assays.
- Developed a novel in-vitro disease model and published a patent.
- Coordinated with cross-functional teams to produce research publications, mentor students, and enhance scientific documentation processes. Develop papers, slide decks, and communication tools to explain technical changes to KOLs.
- Guided undergraduates/fellow graduate students in grant writing, fostering academic development and publication skills.
QUALITY ASSOCIATE, QA
Sun Pharma
Gurugram
03.2015 - 12.2016
- Coordinated closely with the analytical team to guide the resolution of quality events and deviation investigations (OOS/OOT, CAPAs).
- Conducted comprehensive analysis of drug formulation quality attributes while maintaining strict adherence to ICH guidelines and regulatory standards.
- Participated in audits to strengthen laboratory compliance. Led internal audits, ensuring GMP compliance and operational efficiency.
RESEARCH ASSOCIATE, ANALYTICAL DEVELOPMENT
Micro Labs
Bangalore
10.2013 - 03.2015
- Developed RP-HPLC methods for API to analyze related substances and content uniformity, and LC-MS methods for genotoxic impurities.
- Performed routine analysis using LC-MS, GC, and wet lab techniques (potentiometry, KF titration, pH, and identification tests).
- Executed forced degradation studies to validate method specificity and identify degradation pathways.
- Performed trend analysis and statistical interpretation of stability data using validated software, supporting shelf-life assignment and specification setting.
Education
PHD - ONCOLOGY (focus)
North Dakota State University
ND, USA12-2021
MS - PHARMACEUTICAL CHEMISTRY
Punjabi University
Punjab, India05.2013
BS - PHARMACEUTICAL SCIENCES
Punjabi University
Punjab, India05.2011
Skills
- Clinical and Physician Communications
- Data Interpretation & Trending
- Regulatory Submissions (IND, BLA)
- Deviation Management
- External Stakeholder Management
- Root Cause Analysis
- CAPA Implementation
- GMP Compliance
- Audit Readiness
- CGMP Manufacturing Support
- Cross-Functional Liaison
- Communication & Collaboration
Selected Publications
- Horizontal fluid flow bioreactor for cancer research, Dinesh Ramanath Katti, Kalpana S. Katti, Haneesh Jasuja, US Patent Application, US18/300,178
- Interstitial fluid flow contributes to prostate cancer invasion and migration to bone; study conducted using a novel horizontal flow bioreactor, Jasuja H, Jaswandkar SV, Katti D, Katti K, Biofabrication, 15, 2, 025017, 11.061
- Patient-Derived Breast Cancer Bone Metastasis In Vitro Model Using Bone-Mimetic Nanoclay Scaffolds, Jasuja H, Mohammadi FS, Kim J, Gaba A, Katti D, Katti K, Journal of Tissue Engineering and Regenerative Medicine, 2023, 5753666, 10 pages, 4.32
- Perfusion bioreactor enabled fluid-derived shear stress conditions for novel bone metastatic prostate cancer testbed, Jasuja H, Kar S, Katti D, Katti K, Biofabrication, 13, 3, 11.061
Timeline
SCIENTIST III, VIRAL VECTOR SERVICES
Thermofisher Scientific
04.2024 - 04.2025
SCIENTIST, CELL & GENE THERAPY
Sanofi
10.2022 - 04.2024
PRINCIPAL SCIENTIST/TEAM LEAD BIOANALYTICAL TESTING
Eurofins PSS
01.2022 - 09.2022
DOCTORAL RESEARCH ASSISTANT
North Dakota State University
08.2017 - 01.2022
QUALITY ASSOCIATE, QA
Sun Pharma
03.2015 - 12.2016
RESEARCH ASSOCIATE, ANALYTICAL DEVELOPMENT
Micro Labs
10.2013 - 03.2015
PHD - ONCOLOGY (focus)
North Dakota State University
MS - PHARMACEUTICAL CHEMISTRY
Punjabi University
BS - PHARMACEUTICAL SCIENCES
Punjabi University
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