Narasaiah Dontha

Analytical Strategy Lead l Biologics l Cell and Gene Therapies l Viral Vectors l Phase appropriate method validation l IND/IMPD/CTA | BLA/MAA

Role: Analytical Strategy Lead at Bristol Myers Squibb
Location: Summit, NJ, US
LinkedIn followers: 500 followers

Information TechnologyView LinkedIn profile

About Narasaiah Dontha

Results driven analytical leader in multi-disciplinary research areas including biologics (mAbs, bispecifics, ADCs) and LVV based CAR-T and Gene Therapies. Extensive GMP experience in driving excellence and filing INDs, CTAs, BLAs, MAAs and associated HA communications. Innovative and transformational technical leader implementing cutting edge analytical technologies.

Experience

Analytical Strategy Lead
Bristol Myers Squibb
Jul 2022 — Present · Summit, NJ, US
Led the sLVV (suspension Lentiviral Vector) process manufacturing at CRO to decrease vector manufacturing cost• Accountable for authoring several IRs and analytical sections in support of CAR-T cell therapies (Breyanzi® and Breyanzi® ) from various health authorities for timely filing and approvals.• Championed HCP antibody reagents development for cell therapies to reduce regulatory burden and associated comparability studies whenever there is a kit change from the vendor • Established cross functional collaboration between CTD and biologics development to leverage technical know-how in Lentiviral vector characterization and keep characterization knowledge within the company.• Organized technical discussions with vendors to modify instrumentation to enable vector characterization using fluorescent labels to combine multiple analytes into one assay to save money, time and precious vector samples.• Accomplished setting specifications to support regulatory filings which subsequently supported PMR studies.

Education

University of Hyderabad (UoH)
Master's degree, Life Sciences
University of Hyderabad (UoH)
Ph.D., Biochemistry

Skills

Technology Transfer
Monoclonal Antibodies
Uv/Vis
Immunology
Assay Development
High Throughput Screening
Lc-Ms
Life Sciences
Organic Chemistry
Elisa
Lifesciences
Purification
Protein Expression
Chromatography
Cell Biology
Cell
Molecular Biology
Vaccines
Qpcr
Hplc
Gmp
Genomics
Protein Chemistry
Pharmaceutical Industry
Sop
Fda
Biotechnology
Protein Purification
Sds-Page
Immunoassays
Laboratory Automation
Proteomics
Oncology
Fermentation
Validation
Mass Spectrometry
Medicinal Chemistry
Biochemistry
Drug Development
Flow Cytometry

Contact information

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Current company

Bristol Myers Squibb

Pharmaceutical Manufacturing · 39K employees · Lawrence Township, New Jersey, United States

At Bristol Myers Squibb, we work every day to transform patients’ lives through science. That work inspires some of the most interesting, meaningful, and life-changing careers you’ll experience. Join us and pursue innovative ideas alongside some of the brightest minds in biopharma, collaborating with a team rich in diversity of experiences, and perspectives. We have built a sustainable pipeline of potential therapies and are leveraging translational medicine and data analytics to understand how we can deliver the right medicine to the right patient, at the right time, to achieve the best outcome. Whether in a scientific, business or supporting function, a career at BMS means you’ll be inspired every day to grow and thrive through opportunities that are uncommon in scale and scope. Here, you’ll be on the cutting edge of powerful innovation in oncology, hematology, immunology, cardiovascular disease, and fibrosis, with colleagues united in the mission to help patients. Through the Bristol Myers Squibb Foundation, we also promote health equity and seek to improve health outcomes of populations disproportionately affected by serious diseases and conditions. Our mission is to give new hope to help patients prevail over serious disease – it drives everything we do. Review our Social Media Community Guidelines at: https://www.bms.com/social-media-community-guidelines.html

bms.com

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