Linda Kramer
Associate Director Regulatory Affairs @ GSK
Regulatory Affairs CMC Lead at Spark Therapeutics, Inc.
Greater Philadelphia Area
Section title
Linda Kramer's Email Addresses & Phone Numbers
Linda Kramer's Work Experience
GSK
Associate Director Regulatory Affairs
December 2005 to April 2014
King of Prussia
Centocor
Sr QA Compliance Associate
January 2005 to December 2005
Malvern, PA
The Immune Response Corporation
QA Supervisor
January 2000 to November 2002
King Of Prussia , PA
Spark Therapeutics, Inc.
CMC Regulatory Lead Spark Therapeutics
Philadelphia, Pennsylvania, United States
GSK
Director Global Regulatory Affairs
April 2014 to June 2020
King of Prussia
Centocor
Sr Process Scientist
November 2002 to January 2005
Malvern, PA
Tektagen Inc
QA Supervisor
September 1997 to December 1999
Malvern, PA
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About Linda Kramer's Current Company
GSKResponsible for submitting and communicating new vaccine product licensure and post-approval CMC/facility changes to the FDA for international biological vaccine sites. Discussions with Regulatory Authorities, including Type C meetings and GMP site inspections.Management of Global Regulatory Cross Product Team for post approval submissions worldwide. Responsible for submitting and communicating new vaccine product licensure and post-approval CMC/facility changes to the FDA for international biological vaccine sites. Discussions with Regulatory Authorities, including Type C meetings and GMP site inspections.Management of Global Regulatory Cross Product Team for post approval submissions worldwide.
Frequently Asked Questions about Linda Kramer
What company does Linda Kramer work for?
Linda Kramer works for GSK
What is Linda Kramer's role at GSK?
Linda Kramer is Associate Director Regulatory Affairs
What is Linda Kramer's personal email address?
Linda Kramer's personal email address is li****[email protected]
What is Linda Kramer's business email address?
Linda Kramer's business email address is l****[email protected]
What is Linda Kramer's Phone Number?
Linda Kramer's phone (**) *** *** 281
What industry does Linda Kramer work in?
Linda Kramer works in the Pharmaceuticals industry.
Who are Linda Kramer's colleagues?
Linda Kramer's colleagues are Edward Bowen, Chris Hafer, Stacie Patterson, Doug McGeorge, Muhammad Shiam Bin Azad, Faridur Rahman, haykel B.O, Chen-bing Guan, Fedir Indutnyi, and Nataliya Lyubchenko
About Linda Kramer
đŸ“– Summary
Associate Director Regulatory Affairs @ GSK Responsible for submitting and communicating new vaccine product licensure and post-approval CMC/facility changes to the FDA for international biological vaccine sites. Discussions with Regulatory Authorities, including Type C meetings and GMP site inspections.Management of Global Regulatory Cross Product Team for post approval submissions worldwide. From December 2005 to April 2014 (8 years 5 months) King of PrussiaSr QA Compliance Associate @ Centocor Responsible for inspection readiness for Regulatory Authorities.Responsible for performing internal quality audits of the monoclonial antibody manufacturing facility and maintaining a state of compliance of the quality systems for GMP inspections. From January 2005 to December 2005 (1 year) Malvern, PAQA Supervisor @ The Immune Response Corporation Responsible for the Materials Compliance Department for a phase III HIV-1 immunotherapeutic compound. Supervised two specialist level personnel. Performed both domestic and international GMP audits of Raw Material, subcontractor laboratory testing, and subcontractor packaging suppliers. Performed internal quality audits of the manufacturing facility. From January 2000 to November 2002 (2 years 11 months) King Of Prussia , PACMC Regulatory Lead Spark Therapeutics @ Spark Therapeutics, Inc. Philadelphia, Pennsylvania, United StatesDirector Global Regulatory Affairs @ GSK Responsible for management and leading of gloabl team for submitting and communicating new vaccine product licensure and post-approval CMC/facility changes to the FDA, EMA, International health authorities for international biological vaccine sites. Lead several Type C meetings and discussions with FDA and review of scientific advice documents for EMA. From April 2014 to June 2020 (6 years 3 months) King of PrussiaSr Process Scientist @ Centocor Responsible for resolving technical manufacturing nonconformances utilizing both cGMP compliance knowledge and CMC technical processing knowledge. Responsible for CMC process optimization teams and submitting compliance and required regulatory documentation such as CBE-30’s for CMC process improvements and changes. From November 2002 to January 2005 (2 years 3 months) Malvern, PAQA Supervisor @ Tektagen Inc Responsible for the calibrations and validation of laboratory equipment utilized in the assay testing at a contract biological testing laboratory. Assisted the Sr. QA Manager with internal quality operations of the company in support of client quality and regulatory (FDA) audits. Performed GMP/ GLP vendor and subcontractor audits. Inspected and audited lab studies for GMP/GLP compliance.Supervised two technician level personnel. From September 1997 to December 1999 (2 years 4 months) Malvern, PA
Linda Kramer’s Personal Email Address, Business Email, and Phone Number
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In a nutshell
Linda Kramer's Personality Type
Extraversion (E), Intuition (N), Feeling (F), Judging (J)
Average Tenure
3 year(s), 10 month(s)
Linda Kramer's Willingness to Change Jobs
Unlikely
Likely
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