Patricio Massera Email & Phone Number

Catalonia, Spain

Bothell, Wa, Us

Bothell, Wa, Us

Responsible for Global Operations:-Copenhagen site, Seattle site and Berkeley site.-Process development.-Global project management.-Global Supply Chain.-Global IT.

Bothell, Wa, Us

Responsible for CMC Biologics Copenhagen site operations and P&L.Managing Director of Danish Operations at CMC Biologics A/S.Reporting to the Company CEO.Experience with FDA PLI (pre-licence inspections or PAI) and EU inspections. CMC Biologics (CMC) is a global Contract Manufacturing Organization (CMO) with three biomanufacturing facilities in Europe and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services. CMC Biologics also offers non-exclusive license to CHEF1™, a proprietary CHO cell line development platform. CHEF1 delivers stable, high-titer, production-quality cell lines in optimized time frames. It is the foundation of CMC Biologics’ innovative approach to cell line and process development.

Operations Director at Intervet/Schering-plough AH, Salamanca, SpainManufacturing of antigen (live and inactivated egg origin antigens and tissue culture antigens) and vaccines for poultry, cattle, swine, equine and fish.

Responsible for Site Operations:-Site performance follow-up through the four key aspects of the business: Quality, EHS, Customer and Finances (KPIs metrics). -Responsible of the site annual budget planning and follow-up. -Short and long term Site Strategy Plans. -Safety, Health and Environmental planning, monitoring and control.-Internal and External Audits (Global EHS and Quality Audits, GMP and Biosafety Audits).-Lead the Supply Improvement Process Program implementation (RFT projects).-Implementation of Compliance program (Business Continuity Plann).-Engage people into the S-P Culture, leadership behaviors and values.-Active collaboration in the Quality Operation activities (Global Quality Policies, Validation Programs, Control Change Management Program).-Site Characteristics: 130 people site. Biological manufacturing of over 100 million doses per year of foot and mouth disease vaccine. Large scale cell culture systems. Pharmaceutical manufacturing of injectable products (endectocides, vitamins, antibiotics and antiparasiticides).

Garín, Buenos Aires, Ar

1- Large scale vaccine manufacturing of viral and bacterial antigens, from seeds up to formulation and filling. Over 150 millon of doses per year. 2- Cell culture scale-up up to 4000 litres bioreactors.3- Design, implementation and optimization of new processes developed.4- Ensure implementation and compliance with cGMP and ISO9000 quality requirements.5- 100 employees-group management (continous personnel training program).6- Manage the manufacturing budget in order to achieve the annual production plan.7- Cytokine downtream processing purification using large scale chromatography, preparative HPLC and TFF.

1- Manage the fermentation and down stream purification of several cytokines obteined from E.coli and CHO cells(Interferon alpha, EPO, G-CSF, Interleukin, GM-CSF).2- cGMP implementation and validation.3- Purification optimization and design.4- Manage a high-skill manufacturing group (PhDs, Professional and Technicians).

1- Manage Quality Control Department. From raw materials, packaging and final product analysis.2- Development of new analytical techniques (HPLC, UV).3- Manage antimicrobial biological assays.4- Manage regulatory affairs.

Mba, Business Administration, Marketing, Sales, Human Resources, Economics

Biochemist, Biochemistry, Biology, Biotechnology, Pharmacy