●Responsible for team building and other managerial aspects (qualification, mentoring, capabilities improvement etc.)●As part of my role I’m in charge of quality-regulatory aspects and other quality aspects:Quality-regulatory aspects: ● Implementation of standards and regulatory requirements ● Supporting preparation of regulatory files (Comparability reports, CMC etc.) ● Communicating with QP (regulatory aspects, batch release etc.) ● Preparing and accompanying the external auditsOther quality aspects: ● Establishing and defining all procedures of Compliance ● Leading Routine communication with vendors (quality issues, complaints etc.) ● Managing vendors qualification, including: on-site audits, quality agreements etc. ● Managing Internal audits ● Leading the supervision of Quality approval of raw materials and disposables ● Managing Stability programs (policy, protocols and reports) ● Managing Documentation Center ● Managing Change Control system (including processes such as tech transfer from development to clinical production, comparability etc.)

• Establishing the Quality Control (QC) department as part of the R&D unit• Managing a team of up to 20 members• Responsible for employee's recruitment, team building and other managerial aspects• The department includes two main teams: Routine GMP team Methods development & validation team.• Routine GMP team is in charge for performance of release and characterization tests as part of batch release and R&D batch characterization. In addition, the team takes care for the Environmental monitoring.• Methods development &validation team is in charge for developing /improving methods to be used for routine batch release. In addition, this team established the policy and principles of methods validation and performs methods validations. The methods include: potency assays, identification assays, analytical methods (cells counting etc.)

1 Immunotoxin – production and characterization (cloning, expression and purification, binding to antigen displaying cells, affinity determination, , in vitro cytotoxicity assays) of immunotoxin proteins for in vivo assays.2 In-vivo – in-vivo model establishment in the aim of confirming activity of the immunotoxin proteins, and IgG antibodies: working with several kind of mice, s.c injection of tumor cells, growth curve determination, i.v injection of the activate proteins.