Jose Rodriguez-Beltran

Jose Rodriguez-Beltran

Associate Director, Quality - Product Testing @Immunogen, Inc

New York, NY, US
MOBILE NUMBERS
+17•••••••10

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WORK HISTORY

Aug 2020 — Present

Associate Director, Quality - Product Testing @Immunogen, Inc

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Waltham, MA, US

Oversee the GMP compliance of external laboratories (CMO/CTL) performing QC testing for ImmunoGen Products. Manage the ImmunoGen Specification and Stability Program supporting all assets from clinical development through commercialization.

EDUCATION

N/A

Inter-American University of Puerto Rico-Metropolitan Campus

Master of Business Administration (MBA), Industrial Management

N/A

University of Puerto Rico-Mayaguez

Bachelor of Science (BS), Chemistry

SKILLS

Laboratory SkillsTrackwiseValidationBiotechnologyTechnology TransferCapaHplcU.s. Food and Drug Administration (Fda)LaboratoryAnalytical ChemistryHigh-Performance Liquid Chromatography (Hplc)Quality ControlGmpLimsPharmaceutical IndustrySopFdaStandard Operating Procedure (Sop)Analytical Method Validation

ABOUT JOSE RODRIGUEZ-BELTRAN

Quality Assurance / Control Leader with experience within the biotechnology and pharmaceutical industries. Specific areas of expertise include:• Analytical Method Transfer / Validation• Document, Management and Control• CGMP Internal and External Audit • FDA Consent Decree• Laboratory Instrument Qualification • Manufacturing, Facilities and Equipment Validation• Out-of-Specification (OOS) Investigation, Deviation and CAPA • Review and Approve of Method Validation Protocols and Reports• Review and Approve of Technical Reports • Root Cause Analysis and Problem Solving• Team Leadership and Mentoring

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Jose Rodriguez-Beltran — Email, Phone Number & Contact Info | Unifers