Art Berrun
Regulatory Specialist at Tosoh Bioscience - Separations & Purification | Temecula, California, United States
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Art Berrun serves as a Regulatory Specialist at Tosoh Bioscience - Separations & Purification, where he plays a pivotal role in ensuring that the company’s products meet stringent global regulatory standards. With a keen focus on compliance, Art expertly manages requests for product statements, regulatory support files, and quality agreements, which are essential for maintaining the integrity and safety of biopharmaceutical products. His involvement in customer audits not only reinforces Tosoh's commitment to quality but also fosters strong relationships with clients by providing them with the regulatory guidance they need to navigate complex compliance landscapes.
Art’s expertise in current Good Manufacturing Practices (cGMP) and his comprehensive understanding of FDA regulations enable him to offer valuable insights into operational activities, ensuring that both internal teams and customers adhere to industry best practices. He is adept at preparing detailed interpretive analyses of evolving regulatory frameworks, which helps management stay informed about the implications of regulatory changes on product development and market access.
In addition to his regulatory acumen, Art possesses a robust skill set that includes proficiency in quality assurance, data analysis, and laboratory techniques such as ultrafiltration/diafiltration (UF/DF) and mammalian cell culture. His background in research and transfection further enhances his ability to provide informed regulatory support tailored to the unique needs of Tosoh's diverse clientele. Through his dedication and expertise, Art Berrun is instrumental in driving compliance and fostering innovation within the biopharmaceutical industry.
Regulatory Specialist at Tosoh Bioscience - Separations & Purification in December 2022 to Present
Regulatory Affairs Manager at CorDx in July 2021 to December 2022
Research Associate II at City of Hope in July 2019 to July 2021
Quality and Regulatory Specialist at MilliporeSigma in June 2017 to July 2019
Teaching Associate at California State University, Chico in September 2015 to June 2017
Research And Development Associate at California State University, Chico in April 2014 to June 2017
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California State University, Chico, Bachelor of Science - BS, November 2026
California State University, Chico, Master's degree, November 2026
California State University, Chico, Bachelor of Science - BS, November 2026
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REACH Compliance
RoHS
FDA GMP
EUA
Quality Assurance
ISO 13485
In Vitro Diagnostics (IVD)
Pharmaceutical Industry
Regulatory Affairs
Regulatory Compliance
Microbiology
Aseptic Technique
UF/DF
Cell Culture
Mammalian Cell Culture
Good Manufacturing Practice (GMP)
Batch Records
Transfection
Research
Data Analysis
Laboratory Skills
Stem Cells
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Discover more about Tosoh Bioscience - Separations & PurificationWhat is Art Berrun email address?
Email Art Berrun at [email protected] and [email protected]. This email is the most updated Art Berrun's email found in 2026.
How to contact Art Berrun?
To contact Art Berrun send an email to [email protected] or [email protected]. (updated on August 24, 2024)
What company does Art Berrun work for?
Art Berrun works for Tosoh Bioscience - Separations & Purification
What is Art Berrun's role at Tosoh Bioscience - Separations & Purification?
Art Berrun is Regulatory Specialist
What is Art Berrun's Phone Number?
Art Berrun's phone (213) ***-*392
What industry does Art Berrun work in?
Art Berrun works in the Chemicals industry.
Art Berrun Email Addresses
Art Berrun Phone Numbers
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