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Roberta R. Email & Phone Number

Senior Manager, Process Development and CMC Technical Writing at Kite Pharma
Location: Pacifica, California, United States 14 work roles 2 schools
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Current company
Kite Pharma
Role
Senior Manager, Process Development and CMC Technical Writing
Location
Pacifica, California, United States
Company size
3935 employees

Who is Roberta R.? Overview

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Quick answer

Roberta R. is listed as Senior Manager, Process Development and CMC Technical Writing at Kite Pharma, a with 3935 employees, based in Pacifica, California, United States. AeroLeads shows a matched LinkedIn profile for Roberta R..

Roberta R. previously worked as Senior Manager, Process Development/CMC Technical Writing at Kite Pharma and QC Analytical Technical Writer at Biomarin Pharmaceutical Inc.. Roberta R. holds Bachelor Of Science from Humboldt State University.

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Email format at Kite Pharma

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Kite Pharma

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Profile bio

About Roberta R.

20 years of experience in biopharmaceutical drug development and technical operations; from the QC testing bench to onsite CMO audits, Regulatory CMC writing, and all aspects of Quality Assurance (operations and systems). My wide range of experience in biologics, small-molecule, cell therapy, and combination products allows me to quickly adapt to new assignments and changing priorities with success.

Current workplace

Roberta R.'s current company

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Kite Pharma
Kite Pharma
Senior Manager, Process Development and CMC Technical Writing
Pacifica, CA, US
Website
kitepharma.com
Employees
3935
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14 roles

Roberta R. work experience

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Senior Manager, Process Development And Cmc Technical Writing

Kite Pharma

Pacifica, Ca, Us

Senior Manager, Process Development/Cmc Technical Writing

Kite Pharma

Santa Monica, California, United States

Kite is the industry leader in CAR T cell therapy. My role is entirely cross-functional, working with a dynamic team of members from Regulatory, Process Development/Design, MSAT, and Quality to author chemistry manufacturing and controls (CMC) regulatory submissions in the US, EU, and ROW. In 2023 I was the lead Technical Writer for the post-approval change that enabled the company to shorten the CAR T cell manufacturing time for Yescarta from an average of seven days to five days.Author, edit, and review Module 3, CMC regulatory submission sections (for IND, BLA, MAA, and associated regulatory filings)Author responses to agency questions within the required timelineAddress comments from reviewers of all levels, from subject matter expert to executive vice presidents, and support comment resolution on submission contentMaintain CMC regulatory submission plan timelines at the direction of the operations team leadAdhere to company Style Guide, templates, and SOPs for document developmentUse experience in Process Development, Quality, and Manufacturing to identify technical inconsistencies and participate in resolution

Owner/Maker

Renniegoods

Pacifica, California, United States

Feb 2015 - May 2022

Owner/Founder

Craft+Work Studio

Pacifica, Ca

Feb 2018 - May 2021

Senior Associate, Quality Assurance

Valentis, Inc

Burlingame, California, United States

Jul 2002 - Dec 2005

Regulatory Affairs And Quality Assurance Associate

Corgentech Inc
Jul 2001 - Jul 2002

Senior Qa Specialist

Corixa Corporation (Formerly Coulter Pharmaceutical)
Jan 2001 - Jul 2001

Senior Qc Specialist

Coulter Pharmaceutical

South San Francisco, California, United States

Nov 1998 - Jan 2001

Sr. Quality Control Analyst

Genentech
Mar 1997 - Nov 1998

Quality Control Clinical Development Documentation Assistant

Genentech
Aug 1996 - Feb 1997
Team & coworkers

Colleagues at Kite Pharma

Other employees you can reach at kitepharma.com. View company contacts for 3935 employees →

KS Kenny Seltzer Kenny Seltzer Colleague at Kite PharmaSalt Lake City Metropolitan Area, United States View → SH Simone Hulsman Simone Hulsman Colleague at Kite PharmaHaarlem, North Holland, Netherlands View → JS Jeremy Schwartz Jeremy Schwartz Colleague at Kite PharmaSaskatoon, Saskatchewan, Canada View → ND Nick Dinh Nick Dinh Colleague at Kite PharmaHawthorne, California, United States View → JP Jesse Perez Jesse Perez Colleague at Kite PharmaDowney, California, United States View → MC Matthew Chiaramonte Matthew Chiaramonte Colleague at Kite PharmaNew York City Metropolitan Area, United States View → AM Aaron Mendoza Aaron Mendoza Colleague at Kite PharmaCarson, California, United States View → KS Koz Salehi Koz Salehi Colleague at Kite PharmaLos Angeles, California, United States View → DD Dixon David B Dixon David B Colleague at Kite PharmaSanta Monica, California, United States View → CL Christine Lowe Christine Lowe Colleague at Kite PharmaLos Angeles Metropolitan Area, United States View →
2 education records

Roberta R. education

FAQ

Frequently asked questions about Roberta R.

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

What company does Roberta R. work for?

Roberta R. works for Kite Pharma.

What is Roberta R.'s role at Kite Pharma?

Roberta R. is listed as Senior Manager, Process Development and CMC Technical Writing at Kite Pharma.

Where is Roberta R. based?

Roberta R. is based in Pacifica, California, United States while working with Kite Pharma.

What companies has Roberta R. worked for?

Roberta R. has worked for Kite Pharma, Biomarin Pharmaceutical Inc., Renniegoods, Craft+Work Studio, and A.P. Pharma, Inc..

Who are Roberta R.'s colleagues at Kite Pharma?

Roberta R.'s colleagues at Kite Pharma include Kenny Seltzer, Simone Hulsman, Jeremy Schwartz, Nick Dinh, and Jesse Perez.

How can I contact Roberta R.?

You can use AeroLeads to view verified contact signals for Roberta R. at Kite Pharma, including work email, phone, and LinkedIn data when available.

What schools did Roberta R. attend?

Roberta R. holds Bachelor Of Science from Humboldt State University.

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