Description
Full responsibility for laboratory management, including resource and budget management, project oversight, and long-term strategic planning.
Managerial responsibility for implementing GMP principles and ensuring regulatory compliance in the laboratories, in accordance with company procedures and the parent company’s policies.
Accountability for aligning laboratory operations with the company’s quality management system and business objectives.
Responsibility for setting policies regarding laboratory testing.
Oversight of laboratory investigations, change controls, CAPA, SOPs, protocols and reports, and deviations.
Responsibility for the professional and personal development of lab employees.
Ensuring employee proficiency in aspects of quality, safety, and operations.
Responsibility for the certification and training of the chromatography lab team for all relevant activities.
Responsibility for lab team safety.
Participation in and representation of the laboratory during regulatory audits.
Requirements
Bachelor's degree or higher in Life Sciences, Chemistry, Biotechnology, or related fields.
Previous experience in a pharmaceutical laboratory environment operating under GMP conditions.
Expertise in chromatography and hands-on experience with HPLC/UPLC/GC/MS systems.
Familiarity and previous experience with Waters systems and EMPOWER software – an advantage.
Knowledge of pharmacopoeias and regulatory requirements related to chromatography; experience with validations and analytical method transfers.
Experience with LIMS systems – an advantage.
Experience in chromatography of biological products and proteins – an advantage.
Strong leadership, organizational, and team management skills.
Excellent presentation and communication skills, both verbal and written, in Hebrew and English.
Strong interpersonal skills and ability to work effectively with cross-functional teams.
High-level proficiency in English (spoken and written).