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Hamid R. Email & Phone Number

Expert volunteer: USP Council of Experts (Small Molecules) at US Pharmacopeia
Location: San Francisco Bay Area, United States 9 work roles 3 schools
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Current company
US Pharmacopeia
Role
Expert volunteer: USP Council of Experts (Small Molecules)
Location
San Francisco Bay Area, United States
Company size
51 employees

Who is Hamid R.? Overview

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Hamid R. is listed as Expert volunteer: USP Council of Experts (Small Molecules) at US Pharmacopeia, a with 51 employees, based in San Francisco Bay Area, United States. AeroLeads shows a matched LinkedIn profile for Hamid R..

Hamid R. previously worked as USP Council of Experts: Expert volunteer (Small Molecules) at Us Pharmacopeia and Senior Director, Formulations and Clinical Manufacturing at Exelixis. Hamid R. holds Ph.D., Pharmaceutics from University Of Cincinnati.

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US Pharmacopeia

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Profile bio

About Hamid R.

NDA/sNDA projects delivered:- Pexidartinib (Turalio): Pivotal Phase III Formulation development (Formulation patent, NDA approval 2019)- Cobimetinib (Cotellic): Pivotal Phase III QbD-based formulation development (Formulation patent, NDA 2015)- Quetiapine (Seroquel): Formulation development, tech transfer, and NDA submission- Rosuvastatin (Crestor): Authored reports, contributed to formulation and NDA submission- Key pharmaceutical expert: Multiple partnered projects (GDC-0973, PLX9486, and PLX8394)- Development of poorly soluble compounds, amorphous (SDD, HME) and lipid-based formulationsExperienced senior pharmaceutical scientist with extensive product development experience from concept to market, multiple patents, SME in API polymorph, salt screening, pre-formulation, QbD-based formulation development using dry granulation and high-shear wet-granulation.Expert in process selection, scale-up, technology transfer, validation, and CMO selection and management. Proven track record as a constructive team builder and manager with internal and external partners, USP Small Molecules Expert committee member. Excellent FDA/ICH knowledge, multiple IND, IMPD, NDA, and marketed products.

Listed skills include Research And Development, Gmp, Validation, U.S. Food And Drug Administration, and 18 others.

Current workplace

Hamid R.'s current company

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US Pharmacopeia
Us Pharmacopeia
Expert volunteer: USP Council of Experts (Small Molecules)
South San Francisco, CA, US
Website
exelixis.com
Employees
51
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9 roles · 27 years

Hamid R. work experience

A career timeline built from the work history available for this profile.

Expert Volunteer: Usp Council Of Experts (Small Molecules)

Us Pharmacopeia

California, United States

Usp Council Of Experts: Expert Volunteer (Small Molecules)

Us Pharmacopeia

South San Francisco, Ca, Us

Senior Director, Formulations And Clinical Manufacturing

Exelixis

Alameda, California, Us

Leading formulation team responsible for:- Development of FIH formulations (multiple projects) via US and international CMOs- Leading process optimization of NDA stage oncology solid oral formulations - Selection and management of multiple CMOs to deliver early/late-stage CTM supplies- Management of multiple senior formulation scientists (Principal Scientists holding Ph.D.)

Senior Director

Cytokinetics

South San Francisco, California, Us

- Led formulation development team responsible for the development of multiple FIH formulations- Formulation process optimization of NDA stage project (CK-274, Aficamten)- Managed CMOs and delivered early and late-stage CTM supplies using internal/external resources

Aug 2022 - Apr 2023

Executive Director

Escape Bio

South San Francisco, California, Us

- Departure due to company closure (pre-IPO)- Led formulation team responsible for developing FIH formulations and late-stage CTM supplies- Utilized internal resources and external GMP facilities of small and multi-national CMOs.

Apr 2022 - Aug 2022

Senior Director Of Pharmaceutics

Plexxikon Inc.

South San Francisco, California, Us

- Departure due to Plexxikon closure by Daiichi-Sankyo (March 31 2022)- Led formulation development team from discovery to regulatory submissions:- Pexidartinib (Turalio): Developed commercial Formulation (Patent, authored reports, NDA 2019)- Developed multiple (BCS II, III, and IV) projects, discovery and pre-clinical to regulatory submissions- Researched, selected, and managed CMOs, and manufactured CTM supplies for multiple projects- Established the pharmaceutical development team (pre-formulation, formulation, and analytical)- Built Formulation team: Hired, developed, retained staff; built formulation development capabilities

2016 - 2022 ~6 yrs

Director Of Pharmaceutics

Plexxikon Inc.

South San Francisco, California, Us

2013 - 2016 ~3 yrs

Scientist (Manager), Small Molecule Pharmaceutics

Genentech

South San Francisco, California, Us

- Formulated GDC-0973 (Cobimetinib), GDC-0623 (MEKi), GDC-0464 (PI3Ki), AKTi, PLKi, ...- Developed and optimized multiple QbD-based formulations (member QbD Task-force)- Technology transferred projects following scale-up, optimization and validation- Established, staffed, and managed Genentech's 1st small molecule R&D and cGMP Labs

2007 - 2013 ~6 yrs

Senior Scientist

Astrazeneca Pharmaceuticals

Cambridge, Cambridgeshire, Gb

- Developed, optimized, transferred formulations, and authored regulatory submissions- Formulated multiple NCEs: AZD7512, AZD6280, AZD3783, AZD0947, AZD3409, ...- Authored multiple development reports, contributed to scale-up, validation, PAI inspection- AAPS Visiting Scientist, AZ global compaction team lead, CPPR representative (Purdue University)

2000 - 2007 ~7 yrs
Team & coworkers

Colleagues at US Pharmacopeia

Other employees you can reach at exelixis.com. View company contacts for 51 employees →

CN Claire Nicholson Claire Nicholson Colleague at Us PharmacopeiaEcuador View → SS Shelley Starck Shelley Starck Colleague at Us PharmacopeiaSan Francisco Bay Area, United States View → JM Jack Millam Jack Millam Colleague at Us PharmacopeiaSan Francisco, California, United States View → BK Barry Kane Barry Kane Colleague at Us PharmacopeiaSan Francisco, California, United States View → GP Gregorina Parah Gregorina Parah Colleague at Us PharmacopeiaAlameda, California, United States View → AH Alison Hunt, Icp-Acc, Icp-Atf, Pmi-Acp, Cissp Alison Hunt, Icp-Acc, Icp-Atf, Pmi-Acp, Cissp Colleague at Us PharmacopeiaSan Francisco, California, United States View → LP Lucas Partlow Lucas Partlow Colleague at Us PharmacopeiaSan Francisco Bay Area, United States View → DN Doris Ngay, Cpp Doris Ngay, Cpp Colleague at Us PharmacopeiaUnited States View → SZ Shigang Zhang Shigang Zhang Colleague at Us PharmacopeiaSouth San Francisco, California, United States View → DG Dana Gwinn Dana Gwinn Colleague at Us PharmacopeiaStanford, California, United States View →
3 education records

Hamid R. education

Ph.D., Pharmaceutics

University Of Cincinnati

M.S., Pharmacology-College Of Medicine

The Ohio State University

Bachelor'S Degree, Chemistry

Ohio Wesleyan University
FAQ

Frequently asked questions about Hamid R.

Quick answers generated from the profile data available on this page.

What company does Hamid R. work for?

Hamid R. works for US Pharmacopeia.

What is Hamid R.'s role at US Pharmacopeia?

Hamid R. is listed as Expert volunteer: USP Council of Experts (Small Molecules) at US Pharmacopeia.

Where is Hamid R. based?

Hamid R. is based in San Francisco Bay Area, United States while working with US Pharmacopeia.

What companies has Hamid R. worked for?

Hamid R. has worked for Us Pharmacopeia, Exelixis, Cytokinetics, Escape Bio, and Plexxikon Inc..

Who are Hamid R.'s colleagues at US Pharmacopeia?

Hamid R.'s colleagues at US Pharmacopeia include Claire Nicholson, Shelley Starck, Jack Millam, Barry Kane, and Gregorina Parah.

How can I contact Hamid R.?

You can use AeroLeads to view verified contact signals for Hamid R. at US Pharmacopeia, including work email, phone, and LinkedIn data when available.

What schools did Hamid R. attend?

Hamid R. holds Ph.D., Pharmaceutics from University Of Cincinnati.

What skills is Hamid R. known for?

Hamid R. is listed with skills including Research And Development, Gmp, Validation, U.S. Food And Drug Administration, Hot Melt Extrusion, Spray Dried Dispersion, Quality By Design, and Quality System.

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