Fort Collins, Colorado, United States
An accomplished Global BioPharmaceutical Quality executive skilled in leading quality improvement/compliance initiatives in the biopharmaceutical industry. Extensive leadership experience in BioPharma. A microbiologist and proven expert in contamination control, aseptic technique and aseptic filling of sterile products. Comprehensive knowledge and experience in pharmaceutical manufacturing, quality assurance, quality control, quality systems, quality informatics, etc. Proactive situational leader who drives improvement, growth and culture change throughout the organization. Demonstrated success in managing global Quality groups, achieving strategic objectives by delivering on excellence. Skills: Microbiology, Drug Product Manufacturing (aseptic fill, terminal sterilization and lyophilization), Cell Culture and Purification, Inspection Readiness (US FDA, EMA, MHRA, HPRA, AIFA, ANVISA, PMDA, China FDA, etc,), Regulatory compliance, QA leadership, QC Lab management, Strategic Planning, Process Control, Complaint Handling, Risk Management, Leading Cultural Change, ICH Q10 Systems Development, Global Communication, Lean Six Sigma, Coaching for performance, Continuous Improvement, practical, efficient, budgeting, KPI development, SOP, CMC Regulatory Affairs, Good Laboratory Practice (GLP), Validation, Supplier Quality, Data Integrity, Matrixed environment work, analytical, harmonization.
Masterson BioPharma Consulting Group provides consultation services to biotechnology and pharmaceutical companies. Our services include Quality leadership. Quality Assurance, Quality Control, Quality Systems, CMC and leadership improvement as well as business process reengineering and Quality governance to improve efficiency, communication and GXP compliance, including cost reduction. The target audience for Masterson BioPharma Consulting Group is biotechnology and pharmaceutical companies, specifically executive and senior management requiring Quality expertise (e.g. Quality Assurance, Quality Control, Quality Systems, CMC Regulatory, Quality Informatics, GXPs). Companies from small biotechnology companies of 1-10 employees to large multinational companies of greater than 10,000 employees who want to increase GXP compliance, Quality Mindset and productivity as well as reduce costs. Specifically, we specialize in consulting on GMP/GDP processes and organizational governance that may be bogged down by processes, bureaucracy, or those who have technical experts with limited technical or leadership experience or insufficient capacity.
Ipsen is a bio-pharmaceutical company focused on the research, development, manufacturing and commercialization of pharmaceutical products, including biologics, that address medical needs in the specialty care and primary care markets, focused on three main therapeutic areas: oncology, rare diseases and neurology. Sterile, non-steriles, radiopharmaceuticals, liposomes, biologics and small molecules are produced. Directed the global Quality groups at Ipsen, including all GXP Quality functions (GMP, GDP, GVP, GCP, GLP). Managed the clinical and commercial contract manufacturing operations’ Quality compliance activities, including finished drug product, drug product and drug substance manufacturing activities (9 mfg. sites and >20 CMO’s). Managed personnel in the UK, France, US, Ireland, Portugal and China.
Cubist is a bio-pharmaceutical company (virtual manufacturing) focused on the research, commercialisation and creation of pharmaceutical products that address unmet medical needs in the acute care environment. Cubist was acquired by Merck. Directed the global Quality department at Cubist, including GMP QA, GCP/GLP QA, Quality Control and Quality Systems. Managed the clinical and commercial contract manufacturing operations’ QA compliance activities, including finished drug product, drug product and drug substance (28 CMOs) manufacturing activities. Managed personnel in the US and Europe (staff of 50+; direct reports included 3 Directors), including 3 commercial and 4 late stage clinical products.
cGMP Quality expertise