Pablo Daniel Radice Email & Phone Number

Vicente López, Provincia De Buenos Aires, Argentina

Buenos Aires, Argentina

Executing physico-chemical and microbiology testing and review analytical data for Biogen product release with GMP standards (HPLC, UV, Sterility, Karl Fisher, Osmolality, Dissolution, Microbial Limits, Endotoxin). Managing of GXP documentation (writing/translating/reviewing controlled documentation, filing deviations, CAPAs and Global Change Controls). Supporting QA by performing and documenting laboratory investigations and risk assessments. Receiving internal/external audits, ensuring adherence to all regulatory regulations. Project management and technical problem solving. Leading and executing method transfers for new products. Leading local/regional Data Integrity implementation project. Managing and scheduling QC laboratory Validation Master Plan, ensuring qualification, calibration and preventive maintenance of analytical instruments and equipment. Participating or leading cross-functional teams (both local and international) representing QC laboratory, and providing technical support to other QC labs (Uruguay, Chile, Brazil) Conducting accessory GMP activities: performing/documenting environmental (clean area) and water monitoring, routine testing, growth promotion testing of microbiology media and strain identification, managing laboratory reagent stock (yearly budget planning). Interacting with multiple stakeholders across different sectors: Warehouse (handling/storage of quality testing and quality retain samples), Finance (purchase order and invoice management), Customs Brokers and Trade Compliance (coordinating international shipping and importing processes), Vendors (coordinating purchases and technical visits), Supply Chain (finished product logistics). Managing Hazardous waste, pest control, and controlled substances registry and usage (RenPre). Training new hires in all QC laboratory related activities and processes.

Buenos Aires, Argentina

Responsible of testing and review analytical data for the release of Biogen products in Argentina under international GMP standards.Documenting reviews, research protocols, research reports, requests for change control, validation protocols, and report exceptions.Providing technical leadership throug the effective management of projects including laboratory investigations, solving technical problems.Participating effectively in a leadership role or as a member of cross-functional teams as a representative of the laboratory quality control.Leading the execution of transfer methods. Performing and documenting environmental monitoring, routine testing and characterization.

Ciudad Autónoma De Buenos Aires, Argentina

Quality Control for finished products and raw material, under certified GMP Quality Standard (SENASA). Physical-Chemical analysis for finished products and raw material (melting point, active pharmaceutical ingredient quantitation by titration, sample density measurement by pycnometer, pH determination, drying loss determination). Active pharmaceutical ingredient quantitation by HPLC, mineral concentration quantitation by Atomic Absorption Spectrometer. Handling of high accuracy volumetric material. Quality control of containers and packagingContact: Marcelo Centamore. Tel.: +54911 4501-5575 ext. 103

Ciudad Autónoma De Buenos Aires, Argentina

Line of research: Identification and validation of genes involved in the pro-neurogenic of TGF-beta 1. Specific area: Neurosciences.Specific work developed: Molecular and cellular biology techniques. Cell culture: primary cell cultures from animal and human tissues, immortalized cell line handling (culture medium preparation, maintaining and amplification of cell cultures, cell freezing and thawing). Primary murine neural stem cell culture, primary murine microglial culture, somatic cell reprogramming to induced pluripotent stem cells (iPS), handling of commercial cell lines (HeLa, HEK293/293T, A549, PC12). Experience in work under level I and II biosafety hoods. Use of controlled atmosphere cell culture incubators. Extraction and purification of nucleic acids (DNA and RNA), spectrophotometric quantitation of nucleic acids, reverse transcription of RNA, cDNA synthesis, PCR, RT-PCR, quantitative RT-PCR (real-time), handling of end-point and real-time thermocyclers, PCR primer design and set-up, agarose and polyacrylamide gel electrophoresis. Experience in microarray methodology and use of microarray scanners. Protein extraction, purification and quantitation. Western Blot methodology. Antibody handling, immunocytochemistry and immunohistochemistry, fluorescent staining for optical and confocal microscopy, and image analysis. Flow cytometry methodology. Bacterial culture, cloning and sub-cloning, plasmid amplification, selection and expression, sequencing, restriction enzyme patterning. Preparation and use of solid and liquid bacterial culture media (LB, SOC, Agar) for bacterial expansion. Laboratory animal handling (experience in rat handling). Motor behavioral tests (stepping and cylinder test for motor disorders). Adult, neonatal and prenatal murine tissue and organ dissection (especially brain structures dissection).

Buenos Aires, Argentina

Quality Systems implementation (Mario del Giúdice S.R.L., Miguel Abad S.A., Control & Service S.A.) under GMP regulation.

Ph.D. In Biologic Sciences, Neuroscience, 10

Ph.D. thesis: Identification and characterization of the functional role of genes involved in the pro-neurogenic of TGF-beta 1 on adult.

Degree In Biological Sciences, Molecular And Cellular Biology, 8.56

Bachelor With Orientation In Biologic Sciences And Health, Biologic Sciences And Health Specialization, 7.70