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 authoring and mitigate technical challenges- Leads Rapid Response Team/Regulatory Strategic Implementation Team in successful completion of 4000+ responses from multiple global health authorities- Backroom preparation and scribing for FDA and TGA inspections at CMO in India- Support of custom media, formulation, and analytical development departments including preformulation and formulation screening strategies. Technical source document alignment for regulatory submissions.

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, focusing on promoting health lifestyles through novel products that replenish, enhance and vitalize.

• 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 submission (EUA, BLA) and update Master Files for COVID-19 vaccine drug product manufacturing. Support Team Biologics On-Site Investigation. Author briefing book to support Type C meeting. Support FMEAs and QRM for vaccine production at facility, including author of contamination control strategy.• 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. Technical writer for aseptic process simulations. Authored aseptic process description and contamination control strategy/FMEA (Annex 1).• 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 development reports. Support for Extractables/Leachables for monoclonal antibody drug substance. Compiled and analyzed extractable study and toxicology data for manufacturing process contact components, authored final report for submission. Deviation investigator/technical writer for Engineering and Manufacturing.

• 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; draft provisional patents; led market, technical and business assessment for commercial dosage form. (Gila Therapeutics)• 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)• Provide strategy for the development and manufacturing as well as regulatory submission for small molecule injectable suspension (Mayo Researcher)• Define process and conduct new technology assessment in support of next generation product research & development selection and acquisition target recommendations. (RTI Medical Device)• Define regulatory and clinical plan for wound healing medical device, drug/device combination product (RTI Medical Device)• Quality/Regulatory consultant. Drug evaluation/modeling for medical device recall device recall (West Pharmaceutical Services)

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 microbes into a sick person’s intestinal tract.My role is the strategic and tactical leader for the development and commercialization of conventional drug delivery platforms for human-derived microbes. While at Rebiotix, I developed multiple first-in-the-world refrigerated temperature-stable oral microbiota capsule products and their manufacturing processes. Some of the advanced formulations were stable out to at least 12 months at room temperature with no log loss in viable bacteria. I created the R&D department and set up the R&D laboratory. I was responsible for analytical method development and validation utilizing state-of-the-art qPCR methodology and controlled release oral dosage form delivery performance methods.

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 of 21CFR 4. Pharmaceutical development and DFSS consultant for the company. New product concept generation, selection, and assessment. • 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 experience in visual management and ProChain tools.• Teaches DFSS principles and deploys DFSS through the use of tools and methodology for new product development and remediation.

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.

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 interaction with a novel device. The knowledge of the protein stability and its formulation characteristics will guide the advancement of the device design. (Ximedica)

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 products. Forecasted and managed department budget.

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 product development programs (conventional oral solid, controlled release oral solid, oral soft gelatin, nasal, and semi-solid dosage forms). Forecasted and managed departmental budget.

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 for Six Sigma (DFSS) Black Belt (2003 – 2004)As the Division’s first technical DFSS black belt, I trained teams on methodology and established working knowledge of tools, processes, and project management to conduct competitive product and technology development programs utilizing Market Analysis and Segmentation, Voice of Customer, Quality Function Deployment, Concept Generation, Design of Experiments, Critical Parameter Management (CPM), Technical Transfer and Control Plans. Projects included the delivery of macromolecules and advanced transdermal systems. Advanced Research Specialist (2000 – 2003)Studied the compatibility of protein/peptide APIs in pMDIs and completed DPI technology evaluation which resulted in bringing new dry powder inhaler device technology to 3M’s portfolio. Led immune response modifier NCE pMDI feasibilities; key contributor to molecule screening and selection resulting in several records of invention. Senior Pharmacist (1996 – 2000)Solved several complex technical challenges (drug product manufacturing, material compatibility, and device component fabrication) with novel, patentable solutions which resulted in the global commercialization of Qvar® (gold standard for hydrofluoroalkane propellant (HFA) pMDIs).