Chris Masterson Email & Phone Number

Fort Collins, Co, Us

Fort Collins, Co, Us

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.

Boulogne Billancourt, Fr

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.

Lexington, Ma, Us

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

Responsible for developing, implementing and maintaining global, robust Quality Systems.Responsible for building and developing a global, commercial QA organization (57 FTE).Responsible for assuring global cGMP compliance for all Shire Human Genetic Therapies' manufacturing sites and CMO's.Successfully ran or supported many regulatory inspections, including FDA, Japan's PMDA, Health Canada, Brazil's ANVISA, the Swedish MPA, etc.

Us

Transkaryotic Therapies name change to Shire Human Genetic Therapies after acquisition in 2005.

Abbott Park, Illinois, Us

Cambridge, Ma, Us

Oversee Clinical CMO's. Release product.

Cambridge, Ma, Us