Sanjeev Kothari Email & Phone Number | PROFESSIONAL SUMMARY: • Chemistry, Manufacturing and Controls (CMC) Team Leader with twenty-seven years of industry experience in various aspects of CMC as well as management of clinical and commercial supply chain operations. • Demonstrated ability to undertake broader roles and responsibilities in fast-paced, nimble biotech environments/companies that may require hands-on work as the organization is being built from ground up. • Executive level management skills relating to budget management, budget planning/forecasting, board presentations and creating new teams. • Skilled at negotiating vendor (CDMO/CRO) contracts, master service agreements and commercial supply agreements, as well as quality agreements. • Leadership experience in pharmaceutical development (early and late stage) at multiple large and small pharma/biotech organizations and developing products in multiple therapeutics areas that include oncology, neuroscience, metabolic disorders, gastrointestinal diseases, and kidney failure. • Preclinical stage experience: screening physical properties of multiple candidates, developability assessment of candidate molecules for solubility and identifying preclinical formulations for evaluation in animal models (rodents, dogs and monkeys). • Early-stage clinical experience: Participated in pre-IND meetings with the FDA, scaled up synthetic routes for APIs for Phase 1as well as developed several phase appropriate clinical stage formulations (oral, IV, IM and SC injectables). • Late-stage clinical experience: Carried projects through challenging clinical development timelines for world-wide registration and approval. • Regulatory Experience: CMC submissions (NDA, MAA, Canada-NDA etc.) and interactions with regulatory agencies which includes responses to questions and face to face meetings. Examples include: ABILIFY, ONGLYZA, KOMBIGLYZE-XR, COTELLIC, KYPROLIS, XPHOZAH and IBSRELA. • Demonstrated leadership of cross-functional CMC teams (chemistry, analytical and formulations) • Experienced with the first pilot program on Quality by Design (QbD) and QbD-internal expert for the Genentech/Roche QbD teams. Also, involved in evaluating continuous manufacturing concepts during early and late stage-development at AstraZeneca as well as Genentech/Roche. Quality Experience: Developed several SOPs at start-up or early clinical stage companies for processes related to product specifications, analytical procedures or method validations and risk assessment and risk management.

Sanjeev Kothari

PROFESSIONAL SUMMARY: • Chemistry, Manufacturing and Controls (CMC) Team Leader with twenty-seven y...
San Mateo, California, United States

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Sanjeev Kothari’s Email sanjeev.kothari@bioagelabs.com

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Sanjeev Kothari’s Location San Mateo, California, United States

Sanjeev Kothari’s Current Industry Freelance

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Work Experience

Freelance

Pharmaceutical Development Consultant

2024-03-01 00:00:00 - Present

Bioage Labs

Vice President and Head of CMC and Supply Chain

2022-01-01 00:00:00 - 2024-03-01 00:00:00

Ardelyx

Senior Director of Pharmaceutical Chemistry and Formulations

2015-10-01 00:00:00 - 2021-09-01 00:00:00

Onyx Pharmaceuticals

Director of Pharmaceutical Science

2014-09-01 00:00:00 - 2015-09-01 00:00:00

Genentech

Senior Scientific Manager and Technical Development Leader

2010-09-01 00:00:00 - 2014-09-01 00:00:00

Astrazeneca

Team Manager, Product Development (Material Science and Process Engineering)

2007-10-01 00:00:00 - 2010-09-01 00:00:00

Aaps Mse Subgroup

Committee Member

2009-01-01 00:00:00 - 2010-01-01 00:00:00

Bms

Research Investigator I and II; Senior Research Investigator I and II

1998-01-01 00:00:00 - 2007-01-01 00:00:00

University Of Iowa

Graduate Student

1993-01-01 00:00:00 - 1998-01-01 00:00:00

Abbott Laboratories

Intern

1997-01-01 00:00:00 - 1997-01-01 00:00:00

Skills

No Skills Available

Languages

No Languages Available

FAQ About Sanjeev Kothari

Sanjeev Kothari is located at
San Mateo, California, United States

Sanjeev Kothari is a PROFESSIONAL SUMMARY: • Chemistry, Manufacturing and Controls (CMC) Team Leader with twenty-seven years of industry experience in various aspects of CMC as well as management of clinical and commercial supply chain operations. • Demonstrated ability to undertake broader roles and responsibilities in fast-paced, nimble biotech environments/companies that may require hands-on work as the organization is being built from ground up. • Executive level management skills relating to budget management, budget planning/forecasting, board presentations and creating new teams. • Skilled at negotiating vendor (CDMO/CRO) contracts, master service agreements and commercial supply agreements, as well as quality agreements. • Leadership experience in pharmaceutical development (early and late stage) at multiple large and small pharma/biotech organizations and developing products in multiple therapeutics areas that include oncology, neuroscience, metabolic disorders, gastrointestinal diseases, and kidney failure. • Preclinical stage experience: screening physical properties of multiple candidates, developability assessment of candidate molecules for solubility and identifying preclinical formulations for evaluation in animal models (rodents, dogs and monkeys). • Early-stage clinical experience: Participated in pre-IND meetings with the FDA, scaled up synthetic routes for APIs for Phase 1as well as developed several phase appropriate clinical stage formulations (oral, IV, IM and SC injectables). • Late-stage clinical experience: Carried projects through challenging clinical development timelines for world-wide registration and approval. • Regulatory Experience: CMC submissions (NDA, MAA, Canada-NDA etc.) and interactions with regulatory agencies which includes responses to questions and face to face meetings. Examples include: ABILIFY, ONGLYZA, KOMBIGLYZE-XR, COTELLIC, KYPROLIS, XPHOZAH and IBSRELA. • Demonstrated leadership of cross-functional CMC teams (chemistry, analytical and formulations) • Experienced with the first pilot program on Quality by Design (QbD) and QbD-internal expert for the Genentech/Roche QbD teams. Also, involved in evaluating continuous manufacturing concepts during early and late stage-development at AstraZeneca as well as Genentech/Roche. Quality Experience: Developed several SOPs at start-up or early clinical stage companies for processes related to product specifications, analytical procedures or method validations and risk assessment and risk management.

Sanjeev Kothari currently works in the Freelance |

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Sanjeev Kothari has prior
experience in the following industries:
Bioage Labs | Ardelyx | Onyx Pharmaceuticals | Genentech | Astrazeneca | Aaps Mse Subgroup | Bms | University Of Iowa | Abbott Laboratories

Sanjeev Kothari has the following professional experience:
Freelance | Bioage Labs | Ardelyx | Onyx Pharmaceuticals | Genentech | Astrazeneca | Aaps Mse Subgroup | Bms | University Of Iowa | Abbott Laboratories