Beth L. Minter

Director, Chemistry, Manufacturing and Controls

Beth L. Minter is Director, Chemistry, Manufacturing and Controls (CMC) for Cardinal Health Regulatory Sciences.

Role responsibilities

Minter is responsible for scientific and regulatory consulting activities associated with pharmaceutical product development, development of regulatory affairs strategies, managing multidisciplinary drug development teams and preparation of investigational and marketing applications, including post-approval regulatory submissions.  

Professional experience

Minter has more than 28 years of experience in the pharmaceutical industry. Prior to joining Cardinal Health in 1999, she was the quality control manager for ChemSyn Science Laboratories, a specialty contract manufacturer for drug substances. Minter was responsible for the development and validation of analytical methods for drug substances and cleaning validation, as well as the release testing of raw materials, intermediates and drug substances.

Professional affiliations

Minter currently serves on a United States Pharmacopeia (USP) Chemical Medicines Expert Committee.

Education

Minter received a bachelor’s degree (magna cum laude) in chemistry and botany from Northwest Missouri State University.

Areas of Expertise


CMC product development

Quality control

Regulatory affairs

Compliance

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