Vice President of Quality/CMC at Asklepios BioPharmaceutical, Inc. (AskBio); Gene Therapy
Durham, North Carolina, United States
Eli Lilly and Company
Operations Site Lead - Biosynthetic Manufacturing Technical Services
1991 to 1994
Indianapolis, Indiana
Eli Lilly and Company
Sr. Biochemist - Biosynthetic Technical Services
1987 to 1991
Indianapolis, Indiana
Eli Lilly and Company
Process Engineer - Biochemical Engineering & Process Development
1984 to 1987
Indianapolis, Indiana
Eli Lilly and Company
Antibiotic Manufacturing Biochemist - Antibiotic Production
1980 to 1984
West Lafayette, Indiana
Celgene
Site Head Quality Operations - Oncology Commercial Sterile Operations
February 2012 to August 2016
Phoenix, Arizona Area
Coldstream Laboratories, Inc.
Vice President, Quality, Compliance & Regulatory Affairs
2005 to 2012
Lexington, Kentucky
Asklepios BioPharmaceutical, Inc. (AskBio)
Vice President of Quality/CMC
Raleigh-Durham-Chapel Hill Area
Endocyte (Novartis)
Head of Corporate Quality - Cell Therapy Technologies and Targeted Nuclear Oncology
October 2017 to December 2018
Indianapolis, Indiana Area
Aventis Behring
Director, Aseptic Alpha1 Protease Inhibitor Manufacturing Operations - Biopharmaceuticals
2001 to 2005
Kankakee, Illinois
NABI Biopharmaceuticals, Inc.
Sr. Manager, Technical Manufacturing Operations, Regulatory & Quality Assurance
1997 to 2001
Boca Raton, Florida
SyStemix, Inc.
Manager, Corporate Quality
1994 to 1997
Palo Alto, CA
Innovative Cellular Therapeutics (ICT)
Vice President Quality, Compliance & Manufacturing Technology - Cell Therapy Oncology Development
December 2018 to March 2020
Rockville, MD
Cognate BioServices
Vice President Quality Operations & Regulatory Affairs – Cell Therapy (CAR-T) Manufacturing
August 2016 to September 2017
Memphis, TN
Responsible for representing Biosynthetic Technical Services and Quality Assurance on the corporate steering committee associated with the validation planning and design of the new Research and Development Manufacturing Facility being constructed in Indianapolis, intended for the manufacture of recombinant derived protein pharmaceutical late-phase clinical trial material. Responsible for representing Biosynthetic Technical Services and Quality Assurance on the corporate steering committee associated with the validation planning and design of the new Research and Development Manufacturing Facility being constructed in Indianapolis, intended for the manufacture of recombinant derived protein pharmaceutical late-phase clinical trial material.
What company does Tim Mitchell work for?
Tim Mitchell works for Eli Lilly and Company
What is Tim Mitchell's role at Eli Lilly and Company?
Tim Mitchell is Operations Site Lead - Biosynthetic Manufacturing Technical Services
What industry does Tim Mitchell work in?
Tim Mitchell works in the Pharmaceuticals industry.
💼 Past Experience
I saw (registered with FDA and other regulatory agencies) an initial manufacturing sample of an alpha1 protease inhibitor (Api) from their product brandI was responsible for all NPP and QC aspects of the manufacture of this product from a #1 global producer. I managed the process day-by-day, ensuring that all product quality requirements were met and that procedures were followed to minimize the risk of api quality issues. I also ensured that product and material purity was maintained, which contributed to the company's high reputation.They are a global player in beta-lactamase inhibitor manufacturingI saw the raw APi in finished product and resolved quality and product safety issues. We produced high quality Api products that met all customer requirements and customers generally loved them.
🎓 Education
Tim Mitchell's education hasprovided him with a strong background in biochemistry and genetics which has been essential in his current work readiness. Mitchell's education has also provided him with a strong foundation in how to think and problem-solve in scientific disciplines. Additionally, Mitchell's education has given him the ability to workatiably with other team members in order to accomplish tasks.
💡 Technical & Interpersonal Skills
Jason Kavanaugh is currently a Manufacturing Facility Engineer for Alpha-1 Protease Inhibitor Manufacturing at Palatin Biotechnology, LP from 2006 to 2010 (2 years). Jason developed, designed, and manages plant quality control processes and monitors Madison, Wisconsin-based Palatin Biotechnology as a partner in their cooperative research and development program with Hoffmann-La Roche. With PalatinBiotechnology, Jason has led the planning, design and execution of plant design, installation and operation. Jason has also taughtvisory training programs in quality assurance and quality control for advanced cellular technology companies.Product Manager - Scitabolin, Inc. (Clinical Development) from 2006 to 2009 (3 years), also Principal Investigator,(Clinical Development) of a Phase III clinical study of scitabolin (a neoantidiabetic agent) to improve glycemic control in type 2 diabetes mellitus. Jason was responsible for all aspects of the Drug Degradation and Elimination Studies (DDES) and Design and Sponsorship of the Clinical Trial. Jason also served as Project Manager, here at Scitabolin.Head of Manufacturing, Scitabolin, Inc. (Clinical Development) from 2006 to 2009 (3 years), also Principal Investigator,(Clinical Development) of a Phase III clinical study of scitabolin (a neoantidiabetic agent) to improve glycemic control in type 2 diabetes mellitus. Jason was responsible for all aspects of the Drug Degradation and Elimination Studies (DDES) and Design and Sponsorship of the Clinical Trial. Jason also served as Project Manager, here at Scitabolin. Vice President, Manufacturing - African American Diabetes Care (AADA) from 2004 to 2006 (4 years). With AADA, I led the development and implementation of all aspects of the company's manufacturing strategy, including human macromolecule production, PDRAM production, and product quality control. I also initiated and led a number of strategies for marketing and selling the company's products to patients.VP Manufacturing - African American Diabetes Care from 2004 to 2006 (4 years). With AADA, I led the development and implementation of all aspects of the company's manufacturing strategy, including human macromolecule production, PDRAM production, and product quality control. I also initiated and led a number of strategies for marketing and selling the company's products to patients. Vice President and Head of Product Development - human macromolecule production and Scitabolin, Inc. (Clinical Development) from 1999 to 2004 (5 years). With Scitabolin, I led product development including human macromolecule production, PDRAM production, and product quality control. I also initiated and led a number of strategies for marketing and selling the company's products to patients.Human Macromolecule Production - Scitabolin, Inc. (Clinical Development) from1999 to 2004 (5 years). With Scitabolin, I led product development including human macromolecule production, PDRAM production, and product quality control. I also initiated and led a number of strategies for marketing and selling the company's products to patients. Vice President
Introversion (I), Sensing (S), Thinking (T), Perceiving (P)
3 year(s), 4 month(s)
Unlikely
Likely
There's 86% chance that Tim Mitchell is seeking for new opportunities
Enjoy unlimited access and discover candidates outside of LinkedIn
Trusted by 400K users from
76% of Fortune 500 companies
The most accurate data ever
Hire Anyone, Anywhere
with ContactOut today
Making remote or global hires? We can help.
No credit card required
Tim Mitchell's Social Media Links
/school/pu... /company/a...