Edwin Jauregui Email & Phone Number

Fort Lauderdale, FL, US

New York, New York, US

- Supporting product transfer of biosimilar projects from Pfizer sites to external CMOs (US and South Korea) - Participation in GAP assessment analysis, FMEA, Tech Transfer Documentation and PCS.- Coordination with CDMOs regarding Upstream Manufacturing operations and production data review..- PIP activities at different CDMO sites in US and.

South San Francisco, California, US

Person In Plant at external CMO Site overseeing Inclacumab manufacturing operations. Technical support for troubleshooting operational challenges in Cell Culture process.- Review and approval of Manufacturing Batch Records (before and after execution).- Review, and approval of: CAPA’s, Deviations, Change Controls ensuring technical assessment and.

South San Francisco, California, US

- Interaction with multiple CDMOs for coordination in Process Characterization Studies (KBI and AVID), and large-scale manufacturing (Thermofisher-St Louis) for Inclacumab (Monoclonal antibody treatment for Sickle Cell disease)- Participation in developing the Plan, Design, and execution of BLA-enabling projects: DOE and statistical analysis. Collaboration.

Bothell, WA, US

Responsible for managing and developing a production team responsible for manufacturing late-stage, PPQ and commercial batches.Oversee and manage upstream processes from thaw, bioreactors, and recovery operations in a large-scale manufacturing facility, according to cGMP and approved procedures.Responsible for the identification of process equipment/system.

Waltham, MA, US

Responsible for the day-to-day activities in a new ISO 7 clean room suite dedicated to protein purification.- Supported equipment Factory Acceptance Tests, Site Acceptance tests, Commissioning, and Validation. - Authoring of new equipment SOP’s, and participation in technical personnel hiring and training- Achievement of successful Suite GMP release, and.

Waltham, MA, US

Supervision of Upstream Manufacturing Operations in ISO 7 regulated environment.- Ensuring compliance of GMP guidelines and business regulation during execution of activities.- Technical expertise in mammalian cell culture (CHO). Responsible for manage, monitor, and troubleshoot Shake Flaks, Waves, Xcellerex Bioreactors (50L, 500L, and 2000L), and related.

Supervision of Upstream Manufacturing Operations in ISO 7 regulated environment.- Ensuring compliance with GMP guidelines and business regulations during execution of activities.- Technical expertise in mammalian cell culture (CHO). Responsible for managing, monitoring, and troubleshooting Shake Flaks, Waves, Xcellerex Bioreactors (50L, 500L, and 2000L).

Bedford, MA, US

Scheduling of operations in outdoor bioreactors; considering maximum efficiency for manpower in operations and minimum downtime. Direct responsible for the execution of the activities in the field.Allocation of manpower for specifics engineering projects, providing technical support and leadership of team.Close supervision of operations and support to.

Bedford, MA, US

Supervise day-to-day activities of plant technicians and manage their shift assignments; ensuring technical personnel is trained in current versions of all relevant plant safety and standard operating procedures.Responsible for the execution of productions runs in diverse bioreactors, and also responsible for small-scale and large-scale experiments as part.

Bedford, MA, US

Responsible for the execution of all the bioprocesses and the chemical operations.Perform analysis and control of pH, temperature, Optical Density, air and CO2 concentrations, flow levels, and others in diverse reactors.Decontamination Lead; responsible of the complete sterilization of the process. Use of diverse acids and bases to sterilize bioreactors.

San Leandro, California, US

Responsible for monitoring the plant floor operations at different stations: mixing, packing, and labeling at different points within production. Performing receiving control of raw materials and finishing products and verification of COA according to company requirements.Performing Internal Audits in the processing production to verify the conformance of.

Managing an independent retailer for the main TV providers (Dishnetwork & Directv"), and selling their products to commercial and residential accounts.

Arlington, Texas, US

Performing analysis of environmental samples under TCEQ and EPA protocol’ specifications. PID and FID Tests - collect data, and present conclusions on reports and following SOP’s; specialization in Organic Analysis - MBTEX, TPH; analysis of soil, water and air samples for volatiles, semi-volatiles, inorganic and PCB's.

Collection and analysis of production’s samples, following SOPs and customer requirements. Report and record of nonconformance. Supervise and control HACCP, and verify compliance with the GMP; supervising sanitation procedures and production schedules. Control and analysis of statistical production data.

Formulate and develop new products of liquid detergents (Liquid Soaps, hand washer solutions, industrial solvents, and others), analyzing inventory controls, costs, and expenses of production. Collect and analyze production samples

Engineering Management Training

Quality Auditor

Bachelor Of Science (Bs), Chemical Operations