We are looking for a Laboratory Manager to join our Tiberias site. As our Laboratory Manager, you will be instrumental in establishing and elevating our lab operations to the professional standard required for FDA approval and sustained success.
As the Laboratory Manager, you will lead all aspects of our QC laboratory operations. You will guide the labs strategic expansion, ensuring compliance with Good Manufacturing Practice (GMP) and all relevant regulatory guidelines. You will manage and mentor the Analytical team. A major focus of this role will be building the labs capabilities and processes to the professional level required to support successful FDA approval
Key Responsibilities
Develop and implement a long-term strategy for the laboratory, including resource allocation, staffing, and technical direction.
Collaborate with executive leadership to set scientific priorities and milestones tied to regulatory submissions and approvals.
Regulatory Readiness -Drive initiatives to ensure the laboratory is prepared for FDA audits and meets all requirements for product approvals.
Focal point to all aspects of the lab for the FDA submissions.
Participate in preparing regulatory dossiers and provide expert input on laboratory data, results, and quality control procedures.
Establish and maintain rigorous laboratory policies and procedures, ensuring compliance with FDA requirements, Good Manufacturing Practices (GMP), ISO13485, and other industry-specific regulations (e.g., state Focal cannabis regulations).
Oversee regular audits and inspections, implementing corrective and preventive actions as needed.
Implement and improve Standard Operating Procedures (SOPs) to ensure data integrity, reproducibility, and quality control.
Oversee daily laboratory operations, including scheduling, workflow planning, and performance management.
Manage the collection, analysis, and documentation of data to support regulatory submissions.
Maintain and optimize laboratory infrastructure, equipment, and supplies.
Manage analytical method Tech transfer from the R&D lab, including validation and method update.
Full support and implementation of change control processes.
Managing consumable laboratory equipment inventory and orders.
Analysis of laboratory activities for a periodic report (including the number of analyses performed, deviations, OOSs etc.).
Management of the laboratory and verification of work according to ISO13485 and GMP rules.
Requirements: Education- Masters or Ph.D. in Pharmaceutical Sciences, Chemistry, or a related field.
Minimum of 7-10 years of progressive experience in a regulated laboratory environment, with at least 4-5 years in a management role.
Previous familiarity with GMP 21CFR + ICH Regulation
Previous familiarity with ISO13485 advantage
A proven track record of successful FDA interactions or audits
Experience in the cannabis or pharmaceutical industry
Strong understanding of analytical methods and stability studies
Demonstrated ability to write, review, and implement studies, validations, and reports
Excellent written and verbal communication skills to collaborate with internal teams and external regulatory bodies.
Proven leadership and team-building abilities, including conflict resolution and mentorship.
Highly organized, with the capacity to handle multiple projects and shifting priorities.
This position is open to all candidates.
