Salzman Group is an Israeli biotechnology firm focused on the discovery and development of transformative pharmaceuticals located in Katzrin, in the Golan Heights.
Salzman Group is seeking a Quality Control Director and Method Development to manage our analytical laboratory in Katzrin.
Requirements:
Responsible for Management of the QC Manager and Staff, procedures, and systems that apply to QC Laboratories located in Katzrin, Israel and Management of Analytical R&D staff in Katzrin.
Serves as Study Director in Bioanalytical Studies.
Manage the current QC Manager and his staff, procedures, and systems that apply to ADME/PK located in Katzrin.
Oversee activities and documentation of the analysts to ensure that analytical activities and documentation support GLP/GMP efforts and regulatory efforts.
Coordination and management of procedures and documentation supporting drug substance, drug product, and clinical formulation stability studies.
Contribute to the development and to the continuous improvement of the Quality Control of operations extending to the overall Quality system at SCV
.Oversee the analytical (chemical sample) support provided for development of new products.
Oversee the analytical (biological sample) support provided for pre-clinical and clinical trials, including toxicology, pharmacokinetics, and metabolism.
Assignment of individual staff and project teams based on operational needs, available resources, forecasts, budget, etc.
Establish and maintain a state of readiness in preparation for inspection, audit, due diligence, visitation, with regard to compliance and safety.
Audit and/or approve all data and documentation generated by the laboratories, ensuring the integrity, compliance, and ethics of the laboratory operations.
Collaborate with Metrology and Information Technology to develop and maintain preventive maintenance and calibration (IQ/OQ) programs to support the compliance of analytical software and hardware relative to CFR21, and FDA guidelines.
Write, review, and approve protocols, analytical methods, and SOPs impacting the various laboratory activities.
Track and evaluate the performance of employees, analytical systems and compliance systems.
Train QC personnel on all aspect required by regulation (FDA, GMP, GLP, ICH, USP), on analytical techniques and technology. Submit regular updates and status reports to upper management.
Act as a strong liaison between USA and Israel to ensure smooth and robust method and technology transfer
Ensure the safekeeping and inventory of GMP, GLP, Quarantine, and clinical material by continuously improving, and establishing new controls.
Guide and interact with third party laboratories and manufacturers to ensure compliance with SCV operatives.
Contribute information for setting specifications.
Any other tasks which the company may require