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Harini S. Email & Phone Number

Director, Pharmaceutical Development and Manufacturing Strategy at Gilead Sciences
Location: San Jose, California, United States 14 work roles 2 schools
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Current company
Gilead Sciences
Role
Director, Pharmaceutical Development and Manufacturing Strategy
Location
San Jose, California, United States
Company size
14647 employees

Who is Harini S.? Overview

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Quick answer

Harini S. is listed as Director, Pharmaceutical Development and Manufacturing Strategy at Gilead Sciences, a company with 14647 employees, based in San Jose, California, United States. AeroLeads shows a matched LinkedIn profile for Harini S..

Harini S. previously worked as Director, Pharmaceutical Development & Manufacturing Strategy at Gilead Sciences and Director, Commercial Mfg. (Serialization & Traceability) at Gilead Sciences. Harini S. holds Master Of Science, Chemical And Biochemical Engineering from Uc Irvine.

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Gilead Sciences

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Profile bio

About Harini S.

Dedicated and motivated pharmaceutical professional with over 10 years of technical and managerial experience in regulated GMP environment focused on implementation of compliance based systems and processes employing industry best practices. I am passionate about managing and developing high performing teams through mentoring and employee engagement. Skilled in FDA & EU compliance, Validation, Quality Systems & Serialization.

Current workplace

Harini S.'s current company

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Gilead Sciences
Gilead Sciences
Director, Pharmaceutical Development and Manufacturing Strategy
San Jose, CA, US
Website
gilead.com
Employees
14647
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14 roles

Harini S. work experience

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

Director, Pharmaceutical Development And Manufacturing Strategy

Gilead Sciences

San Jose, CA, US

Director, Pharmaceutical Development & Manufacturing Strategy

Current
Gilead Sciences

Foster City, CA, US

Dec 2023 - Present

Director, Commercial Mfg. (Serialization & Traceability)

Gilead Sciences

Foster City, CA, US

  • Head of Global Serialization & Traceability function at Gilead, leading projects and steady state operations
  • Leading implementation of technology and business processes for various global compliance initiatives such as US DSCSA, UAE etc.
  • Collaborate with Product Security, Managed Markets and Quality organizations on leveraging capabilities to secure the supply chain and assess value beyond compliance opportunities
Mar 2021 - Dec 2023

Assoc. Director, Commercial Mfg. (Serialization & Traceability)

Gilead Sciences

Foster City, CA, US

  • Business lead for implementation of aggregation capabilities and new enterprise systems across CMOs, global manufacturing sites and Third Party Logistics Providers (3PLs) in compliance with 21 CFR Part 11/ Annex 11 to.
  • Overseeing enterprise serialization business teams including managing project activities, budget, resource requirements and hiring needs for multiple initiatives across the program
Aug 2019 - Mar 2021

Sr. Manager, Supply Chain (Serialization)

Gilead Sciences

Foster City, CA, US

  • Business process owner and operations lead for enterprise serialization and traceability technology systems and processes
  • Responsible for managing operations, personnel and business activities to implement system capabilities and processes in accordance with the budget and timelines to meet global compliance requirements (US DSCSA, EU.
Feb 2018 - Aug 2019

Manager, Validation

Gilead Sciences

Foster City, CA, US

  • Developed and executed validation strategies, resource management and planning for end-to-end manufacturing, fill-finish, inspection and packaging operations of a new manufacturing site producing lyophilized.
  • Directed the development of schedules, project plans, master plans, validation protocols and reports for systems to support commercial manufacturing.
Aug 2017 - May 2019

Associate Manager, Manufacturing

Gilead Sciences

Foster City, CA, US

  • Managed overall activities and operations within the Manufacturing Department for aseptic processing, inspection and packaging of lyophilized pharmaceutical products including the coordination of production schedules.
  • Responsible for delegating and ensuring completion of personnel management activities, including hiring, training, evaluating and performance review
Sep 2016 - Aug 2017

Validation Engineer

Gilead Sciences

Foster City, CA, US

  • Responsible for the evaluation, development and testing of fill finish and packaging lines to validate pharmaceutical manufacturing processes and equipment
  • Conducted and contributed directly to the completion of validation testing projects through the development of schedules, plans, validation test protocols and reports for systems to support clinical and commercial.
  • Assisted in preparation of regulatory submissions and presented validation policies and documents in respective areas of Subject Matter Expertise (e.g. computerized systems, automation, manufacturing equipment etc.) to.
Oct 2014 - Sep 2016

Project Manager

Biospeq

Irvine, CA, US

Jul 2014 - Oct 2014

Senior Engineer

Biospeq

Irvine, CA, US

Jul 2011 - Jul 2014

Engineer Ii

Biospeq

Irvine, CA, US

Feb 2010 - Jul 2011

Validation Engineer

Biospeq

Irvine, CA, US

Oct 2008 - Feb 2010

Validation Intern

Biospeq

Irvine, CA, US

Jun 2008 - Sep 2008
Team & coworkers

Colleagues at Gilead Sciences

Other employees you can reach at gilead.com. View company contacts for 14647 employees →

EB Eran Bar-Haim Eran Bar-Haim Colleague at Gilead Sciences Israel, Israel View → JM Jennifer Martinez Jennifer Martinez Colleague at Gilead Sciences Davis, California, United States, United States View → CO Cansu Ozdemir Dilik Cansu Ozdemir Dilik Colleague at Gilead Sciences United Kingdom, United Kingdom View → DH Dawn Hogan Dawn Hogan Colleague at Gilead Sciences Greater Boston, United States View → KS Kerstin Schmidt, Ph.D. Kerstin Schmidt, Ph.D. Colleague at Gilead Sciences San Francisco Bay Area, United States, United States View → KD Katerina Donta Katerina Donta Colleague at Gilead Sciences Greece, Greece View → RC Rachel Cahill Rachel Cahill Colleague at Gilead Sciences Cork Metropolitan Area, Ireland View → FH Franklyn Herrera Franklyn Herrera Colleague at Gilead Sciences New York City Metropolitan Area, United States View → GB Grainne Brady, Aca Grainne Brady, Aca Colleague at Gilead Sciences Ireland, Ireland View → RB Robert Benz Robert Benz Colleague at Gilead Sciences Raleigh-Durham-Chapel Hill Area, United States, United States View →
2 education records

Harini S. education

Master Of Science, Chemical And Biochemical Engineering

Uc Irvine

Bachelors Of Technology, Biotechnology

Srm University
FAQ

Frequently asked questions about Harini S.

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

What company does Harini S. work for?

Harini S. works for Gilead Sciences.

What is Harini S.'s role at Gilead Sciences?

Harini S. is listed as Director, Pharmaceutical Development and Manufacturing Strategy at Gilead Sciences.

Where is Harini S. based?

Harini S. is based in San Jose, California, United States while working with Gilead Sciences.

What companies has Harini S. worked for?

Harini S. has worked for Gilead Sciences, Design Thinking At Uc Riverside Extension Professional Studies, and Biospeq.

Who are Harini S.'s colleagues at Gilead Sciences?

Harini S.'s colleagues at Gilead Sciences include Eran Bar-Haim, Jennifer Martinez, Cansu Ozdemir Dilik, Dawn Hogan, and Kerstin Schmidt, Ph.D..

How can I contact Harini S.?

You can use AeroLeads to view verified contact signals for Harini S. at Gilead Sciences, including work email, phone, and LinkedIn data when available.

What schools did Harini S. attend?

Harini S. holds Master Of Science, Chemical And Biochemical Engineering from Uc Irvine.

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