Scope/Responsibilities:- Certifying manufactured batches IMP (sterile and non-sterile) for Phase 1 trials.- Approving Manufacturing Batch Records, Analytical Protocols and Specification Documents- Approving documentation regarding process simulation and validation.- Responsible person for Environmental Monitoring (EM) of the GMP areas and approving EM reports and protocols.- Attend GMP audits as Responsible Person for Environmental Monitoring and Cleaning of the Classified Areas.- Ensure manufactured IMP is optimal and in accordance with GMP/GCP, ICH, FDA, Federal, State and local guidelines and in agreement with the Sponsor.

Scope/Responsibilities:- Responsible for the pharmaceutical aspects of clinical trials including: manufacturing, packaging/labelling and distribution of IMP.- Consulting sponsors, Project Managers, Physicians and Clinical Study Managers on the manufacturing, distribution and administration of medication.- Support audits with regards to Environmental Monitoring and Cleaning of the Classified Areas.- Reviewing Clinical Study Protocols.- Writing and reviewing IMPDs/INDs and Manufacturing Batch Records.- Ensure manufactured IMP is optimal and in accordance with GMP/GCP, ICH, FDA, Federal, State and local guidelines and in agreement with the Sponsor.- Translation of product manufacturing from a R&D setting to a GMP setting.- Acting as Radiation Protection Expert for the manufacturing facility.

Scope/Responsibilities:- Verifying operational activities (practical and administrative) of the Pharmacy Technicians.- Consulting sponsors, Project Managers, Physicians and Clinical Study Managers on the manufacturing, distribution and administration of medication.- Reviewing Clinical Study Protocols.- Writing and reviewing IMPDs/INDs and Manufacturing Batch Records.- Ensure manufactured IMP is optimal and in accordance with GMP/GCP, ICH, FDA, Federal, State and local guidelines and in agreement with the Sponsor.- Co-Responsible for the pharmaceutical aspects of clinical trials including: manufacturing, packaging/labelling and distribution of IMP.- Translation of product manufacturing from a R&D setting to a GMP setting.

Scope/Responsibilities:- Coordination of clinical studies in cooperation with peer investigators and/or the pharmaceutical industry.- IMP release on site for administration.- Deputy supervisor of the unit