Beth Brown, Ph.D., R.Ph. Email & Phone Number

Minneapolis, Minnesota, United States

President of Brown Squared Consulting, LLC full time, current contract with Novavax in Gaithersburg, MD since Apr 2021:- Provides direct support to Regulatory CMC Executive Director & Regulatory Affairs CMC leaders- Leads CMC strategic planning, organization, and management of EUA/BLA and other global submissions- Supports global Module 2 and 3 document.

Jackson, Wyoming, United States

Product invention and development of patented non-prescription natural ingredient topical formulations that activate biochemical processes for muscle relaxation which increase blood flow. Our products result in the improvement of athletic mobility and sexual performance at the point of contact. REV is an investor-funded pharmaceutical start-up company.

Indianapolis, Indiana, United States

• Contract Vaccine Product Manufacturer, Albuquerque, NM; Remote Position: MN (Astra Zeneca/AMRI)Duration of Assignment: 7 months Project manager for regulatory and quality assurance consultants. Author regulatory.
• Large Biopharmaceutical Company, Grange Castle, Ireland, Remote Position: MN (Takeda)Duration of Assignment: 6 Months Lead reviewer for stem cell EMA submission.
• Contract Drug Product Manufacturer, Cleveland, OH; Remote Position: MN (Gilead/Xellia)Duration of Assignment: 7 months Technical transfer team for Covid-19 therapy. Technical Operations Support for COVID-19 therapy..
• Large Biopharmaceutical Company, Twin Cities, MN Onsite (Takeda)Duration of Assignment: 9 Months Technical writer and data verifier for Host Cell Protein Investigation. Technical writer for Technical Operations.

Plymouth, Minnesota

• CMC Consultant
• Quality/Regulatory consultant. Drug evaluation/modeling for medical for a start-up pharmaceutical company, leading the development of a peptide through toxicology studies, author IND, Clinical Phase I and Phase IIa.
• Create business plan, develop regulatory 510k strategy, author 510k, design clinical survey & data analyses, oversee biocompatibility/consensus standard testing, and author patents for non-prescription product line.
• Author IND CMC submission for small organic molecule suppository product. (Nivagen)
• Author ANDA for a sterile biologic injectable solution (First to File). (Celista/AMRI)
• Author analytical method validation reports for animal health oral tablet products. (Bimeda)

Roseville, Minnesota

Rebiotix Inc. is a biotechnology company founded in 2011 to revolutionize the treatment of challenging gastrointestinal diseases by harnessing the power of the human microbiome. The company is developing an entirely new kind of biological drug designed to reverse pathogenic processes responsible for disease through the transplantation of live human-derived.

Minnetonka, Minnesota

• Reports to the Senior Vice President of Global Procurement/Manufacturing/Distribution/Quality/ Regulatory Affairs/R&D. Leads a multi-disciplinary team for drug/device combination product remediation and implementation.
• Oversees InhibiZone® analytical methods development and validation, process optimizations (60% cost reduction), process qualifications, and 21CFR 4 compliance plan development and execution. Project leader with.
• Teaches DFSS principles and deploys DFSS through the use of tools and methodology for new product development and remediation.

Twin Cities, MN

Retail pharmacy - dispensing prescriptions for drugs and medical devices, patient counseling.This experience is providing me valuable insight into prescriber behaviors, patient needs, and third-party payer dynamics.

Twin Cities, MN

Pharmaceutical and Medical Device Consulting for product and technology development. Project work includes:1. Deployment of Quality by Design through the use of QbD tools and product development project planning (Morton Pharmaceuticals)2. Education on the fundamentals and experimental approach to understand protein drug stability, its performance and.

Greater Seattle Area

Recruited by and reported to the Vice President of Formulation and Process Development. Responsible for managing a multi-disciplinary department of scientists, medical device engineers, engineering firms, and consultants. Oversaw technical and regulatory product development for new chemical entity (NCE) inhalation (nebulizer, pMDI, DPI) drug/device.

Recruited by and reported to the Vice President of Pharmaceutical Sciences and Project Management. Responsible for the leadership of 30 scientists including consultants and contractors within Pharmaceutical Development and Drug Delivery. Oversaw technical and regulatory product development activities for greater than 10 NDA, ANDA, OTC, and nutraceutical.

Recruited by and reported to the Vice President of Business Development and Technical Operations. Leader for all in-licensing and acquisition activities for Cephalon drug delivery. Supported business development to reach third party drug delivery business revenue goals.

Global Technical Project Leader (2004 – 2005)Responsible for global technical management of the 3M/MicroDose dry powder inhaler co-development and marketing collaboration. Developed and executed strategy and tactical plans for global dry powder inhaler capabilities including partner project plans utilizing Design for Six Sigma methodology. Division Design.

Ms, Phd, Pharmaceutics

Bs, Pharmacy