דרושים Microbiologist Ii ב-טבע

The Microbiology Manager is responsible for overseeing all microbiological testing activities in compliance with GMP, GLP, and regulatory requirements. This role leads a team of microbiologists performing testing on commercial and stability products, environmental monitoring, water testing, and microbial identification. The Manager ensures data integrity, regulatory compliance, and continuous improvement within the microbiology laboratory while providing technical leadership and supporting investigations.

• Oversees microbiological testing of commercial and stability products, environmental monitoring, water testing, and microbial identification. using compendial and in-house methods.
• Contributes to the management of the Quality Control Laboratory by actively participating in and facilitating meetings, addressing and resolving operational and management issues that arise.
• Supervise and lead the Microbiology Lab, responsible for performance management, mentoring, and professional development.
• Provides coaching, feedback, and technical guidance to ensure consistent performance and adherence to best practices.
• Effectively communicates, exhibits the company values, maintains priorities and monitors training to ensure a high standard of performance.
• Responsible for staff in accordance with the OHSA, Teva EH&S policies and procedures (including WHMIS, PPE etc.).
• Ensures staff are trained in, and adhere to, safe operational practices and work procedures.
• Prepares weekly schedules and assigns laboratory tasks to support manufacturing and release timelines.
• Ensures accurate and timely generation, review, and approval of test data and reports.
• Ensures data integrity across all microbiological operations by enforcing proper documentation practices, system controls, and adherence to ALCOA+ principles.
• Troubleshoots complex technical issues related to microbiological methods, equipment, and test results.
• Serves as a subject matter expert (SME) and key contact during regulatory inspections for all microbiology-related areas, providing data support, explanations, and audit readiness oversight.
• Maintains compliance with GMP, GLP, and corporate quality policies.
• Reviews and approves laboratory documentation, including test results, investigations, deviations, and change controls.
• Supports timely initiation and tracking of required laboratory investigations.
• Leads and support projects focused on process optimization, method improvement, and regulatory compliance.
• Collaborates with cross-functional teams in various business units such as Quality Control, Quality Assurance, Manufacturing, and Regulatory Affairs.
• Generates trending reports and completes analysis, metric development, and continuous improvement initiatives.
• Manages laboratory resources, including media, reagents, and consumables, ensuring cost-effective operations.
• Identifies, Prevents, and proactively corrects workplace hazards and conditions. Performs incident /accident investigations, root cause analysis, and establish appropriate corrective actions as needed.
• Role modelling of EHS practices to prevent the release of materials/energy, reduce EHS impacts, and ensure adherence to EHS regulatory requirements and procedures.
• Performs other related duties as required.

• Bachelor’s degree in Microbiology or a related scientific field; advanced degree preferred
• Minimum of 8 years of relevant experience in a pharmaceutical microbiology laboratory, with relevant leadership experience
• Strong technical expertise in microbiological methods and instrumentation, including endotoxin testing systems, microbial identification platforms (e.g., Vitek, Biolog, Omnilog), autoclaves, and sterility isolators
• In-depth understanding of GMP/GLP regulations, compendial standards (USP, EP, JP), and pharmaceutical microbiology principles
• Proven ability to ensure data integrity and compliance with data governance requirements
• Excellent analytical, problem-solving, and troubleshooting skills
• Strong communication and documentation abilities, with proficiency in writing technical reports and SOPs
• Proficient in Microsoft Office (Word, Excel, PowerPoint) and laboratory information systems
• Demonstrated leadership, organizational, and time management skills with the ability to manage multiple priorities
• Experience representing the microbiology function during regulatory audits and customer inspections, ensuring readiness and robust data presentation
• Committed to fostering a positive, inclusive, and safety-conscious work environment
• Demonstrates excellent written and verbal communication skills in order to:
  • Interpret analytical data and discuss the issues/problems with the supervisor and peers if required
  • Write in a lucid format, GLP/AITs, SOP’s, analytical reports and other relevant QC documents
• Good computer skills with proficiency in Microsoft Office and Labware LIMS, SAP navigating online compendia publications,
• Analytical methods and techniques common to QC Microbiology Lab
• GMP, cGMP and other regulatory requirements

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

• Collection and preparation of documents intended for submission of CMC variation packages
• Evaluation of changes and support for their implementation in drug documentation for EU, US, IL market, as well as monitoring the status of requests and agreed activities
• Participation in meetings for projects within responsibility and informing other organizational units about the content of the registration file
• Work with regulatory team and other functions to create solutions and implement agreed mitigation plans
• Provide regulatory input throughout the product life cycle of responsible product lines and understand or raise regulatory obstacles to Head of regulatory Function
• Preparation of responses to authorities’ requests within regulated timeframe
• Update status through electronic systems, database and relevant forums

• University degree (Pharmacist/Biologist/Chemist/ Engeneering/ Biomedical)
• 2-3 years of experience in regulatory affairs in CMC, quality assurance and control, drug development or analytics will be an advantage
• Experience of working with Multi-national companies in Pharmaceuticals
• Knowledge in regulation, requirements and guidelines
• Proficiency in written and spoken English and Hebrew
• Ability to work in dynamic environment, multi-tasking,
• Ability to work both individually and in the team, to cooperate on cross-country level and with different business units
• Experience in global environment- advantage
• Experience with sterile products
• Experience with medical device combined product- advantage
• Knowledge with electronic systems and databases

Assoc Dir Regulatory Affairs

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.