Arvind Srivastava, Ph.D. Email & Phone Number

New York, Ny, Us

Philadelphia, Pennsylvania, Us

Third Arc Bio is dedicated to developing multifunctional antibodies that precisely activate or inhibit T cells at a tissue-specific level. This approach aims to achieve superior efficacy and safety for solid tumors and immune and inflammatory diseases.

Provide comprehensive end-to-end CMC consultancy to biotech companies, pharmaceutical firms, and compounding pharmacies, supporting the development of life-saving small molecules, proteins/peptides, and biologics.

Radnor Township, Pennsylvania, Us

Led Contract Development and Manufacturing Organization (CDMO) with 20+ senor level professionals, overseeing operations across cell line development, cell culture, purification, analytical, formulation and fill / finish. Managed and forecasted resources effectively. Conducted technology assessments, identified operational challenges, and implemented innovative technical solutions to enhance manufacturing efficiency. Authored and reviewed technical reports and whitepapers to support clients in regulatory submissions.Selected accomplishments:• Cultivated engaging and collaborative work culture, improving employee survey results from mid-60s to over 90%.• Established antibody and gene therapy platforms and optimized efficient workflow solutions by building infrastructure and hiring 20+ skilled professionals.• Oversaw development of purification process for highly sensitive multi-specific antibody, boosting yield by 30%+ and transferring technology to the client.• Led team in formulating high-concentration products with proprietary excipients, achieving 90% reduction in viscosity and enhancing product stability.• Developed proprietary technology that improved AAV manufacturing yield by 30%.

Indianapolis, Indiana, Us

Led team of 15, including director and senior scientists developing biologics from early-phase to late-phase, including post-market changes. Served as primary liaison between CMC team and management, accountable for technical success of bispecific projects. Offered strategic guidance on developability assessments for new products in collaboration with research team. Played pivotal role in driving continuous process improvement and developing life-cycle management strategies.Selected accomplishments:• Reduced first human dose (FHD) timelines by 6 months for bispecific through innovative development strategies.• Partnered with cell culture, purification, and analytical teams to design streamlined purification process for bispecific product, consolidating 3-unit operations into 2 and reducing production costs by 20%.

Indianapolis, Indiana, Us

Led team of 12, including managers and senior scientist level professionals overseeing drug product development and manufacturing process development, drug-device development from early development stages through regulatory submissions, focused on creating efficient processes and control strategies for clinical and commercial drug products. Actively participated in governance and portfolio reviews to provide guidance on continuous improvement and organizational strategy.Selected accomplishments:• Led formulation and process development, tech transfer, and process validation for 4 commercial drug products, authored BLA, and supported global pre-approval inspections and GMP audits.• Developed risked-base formulation and process for 15+ biologics and authored IND, enabling FHD in less than 12 months.• Designed creative bridging study between historical and new analytical methods in partnership with analytical team, achieving 36-month commercial shelf-life for Cyramza based on 6 months of primary stability data.• Established risk-based, phase-appropriate comparability study designs for API and drug product, leading to 30% reduction in analytical tests by eliminating non-stability-indicating assays.

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Promoted to establish internal capabilities for phase-appropriate formulation development of biologics from early phase through commercial registration. Led design, execution and delivery of formulation and process development studies for liquid and lyophilized products.

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Led formulation development of new drug candidates on a timely manner and communicated formulation decisions to senior management. Supervised and reviewed performance of a group of formulation scientists and analysis.

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Senior Scientist, Formulation (2005-2005)Led a team responsible for developing formulation, analytical methods and characterization for biologics drug products. Enhanced the analytical capability and brought high throughput concept into the formulation screening.

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Scientist III, Formulation (2003-2004)Led formulation development and developed stability indicating methods. Provided guidance to junior colleagues.

Postdoc, Biochemistry

Doctor Of Philosophy - Phd, Chemistry

Master Of Science - Ms, Chemistry