Randal Meyer Email & Phone Number

Sioux Center, Ia, Us

Sioux Falls, South Dakota, United States

• Manage team of 8-10 Quality Control analysts in a clinical-stage biopharmaceutical company, • Collaborate and trouble shoot with other departments including R &D and manufacturing.• Develop, author and review protocols for assay development and validation.• Investigate and solve problems with analytical protein assays including ELISA, HPLC, SDS-PAGE, Western Blot and microbiological techniques. • Improved and optimized eight analytical assays to date• Write and edit detailed standard operating procedures, protocols, reports, and other QC documents to various audience levels.• Design and oversee analytical testing according to USP and ICH guidelines.• Assist with and oversee validation of assays according to ICH guidelines• Review validation and stability analytical data.• Supervise contract research/ testing organizations.

Sioux Center, Iowa

• Consult with companies, farmers, and gardeners about improving soil health and compost quality• Analyze soil and compost for beneficial biological organisms• Establish database of contacts within regenerative agriculture, soil health and soil biology arenas.

Sioux Center, Ia

I have been involved in the nutraceutical and protein purification industries for over 25 years. As owner and CEO of IntegriZyme, I am primarily involved with contract R & D, consulting, regulatory writing, and product development of various natural products that aid researchers as well as improve human, livestock, and plant health and well-being. My writing experience has focused on writing SOPs in support of 21 CFR Part 111 cGMP, writing and revising client's Drug Master File for FDA submission and authoring technical information in the life sciences.

Sioux Center, Ia

As R & D Director, I was involved in isolation, purification, and testing all of the research proteins for Sioux Biochemical. These included pituitary hormones and various enzymes. Also responsible for developing new products and new processing procedures as well as improving current production methodologies at Sioux Pharm, Inc. to optimize product quality and yields for chondroitin sulfate as well as other products. Developed and optimized several bacterial fermentation processes. Authored two patents. Also oversaw and implemented the quality-control testing on chondroitin sulfate and was responsible for writing many of the standard operating procedures and regulatory documents in support of 21 CFR Part 111 cGMP and ICH requirements as well as performing other various QC/QA responsibilities until the company sold..

Doctor Of Philosophy (Ph.D.), Animal Science (Physiology)

Activities and Societies: Research Fellowship American Society of Animal Science Society for the Study of Reproduction Gamma Sigma Delta.

Master'S Degree, Animal Physiology

Bachelor'S Degree, Animal Sciences