Title:  Supervisor Laboratory

Job Summary

Plan, manage and supervise the activities of the laboratory and its analysts. Perform all analytical testing and ensure their delivery in an accurate and timely fashion using proper cGMP & safety precautions. Provide day to day technical and administrative support.

Essential Duties and Responsibilities

• Support the Laboratory Manager in generating and executing on Instrument Qualification protocols or test method transfer protocols, generating Standard Operating Instructions or implementing workflows.
• Supervising a group of Analysts, with the goal of performing all analytical testing that is required to support plant operations. This includes release testing and YBB testing for other West Laboratories in addition to YBB stability and registration testing.
• Analytical Testing will cover but is not limited to wet chemical analysis and functional testing.
• Implementing processes and procedure to ensure on-time delivery of testing in compliance with cGMP, YBB and any other relevant regulatory guidelines/industry standards and the relevant local and global safety guidelines.
• Liaise with Global YBB team as representative site/team
• Guiding customer audits and responses in the analytical laboratory area.
• Investigating OOS/OOT results and implementing CAPAs related to the analytical testing.
• Supporting/executing qualification/validation activities within the laboratory.
• Supporting other functions (e.g., R&D, TCS, process engineering, supply chain, other labs) as SME for YBB.
• Contributing to the harmonization of test methods, equipment, infrastructure, etc., based on the strategy of the Global West Laboratory organization
• Developing/implementing new test methods in alignment with global West laboratory strategy.
• Approval of Documents in the Laboratory Supervisors (Micro/Particle/Chemistry) absence: SOIs, ESOPs, EWIs, Attachments, Protocols, Reports, Strategy documents, Risk Assessments, OOS Investigations, Deviations.
• Compliance to all site Environmental, Health and Safety requirements, training and regulations.
• Act in accordance with the company’s guiding principles and adherence to the Corporate Code of Conduct.
• Implementing processes and procedures to ensure on time delivery of testing in compliance with cGMP, relevant regulatory guidelines and industry standards
• Responsible for the execution of training for the team; identification of training requirements for the team.
• Lead in the continuous improvement of Laboratory processes- playing an active and key role supporting the team in continuous improvement initiatives/projects.
• Manage the team’s performance, conduct performance 1 to 1’s, support recruitment, training and development plans while addressing any issues that arise in a timely manner.
• Own the development process for each team member. Delegation of development objectives and activities assigning tasks, reviewing work and completion of appraisals in line with the company targets.
• Maintain a positive employee relations atmosphere. Ensure that there is good communication and co-operation by encouraging knowledge sharing.
• Compliance to all local site Environmental, Health and Safety regulations.
• Compliance to all local site company policies, procedures and corporate policies.
• Other duties as assigned

Basic Qualifications

•    Bachelors Degree in Science/Chemistry is required.

Work Experience

• Minimum 5 years in laboratory administrative/Co-Ordinator/Analyst role
• Experience working in a laboratory or cGMP/pharmaceutical environment.
• Previous experience in Medical Device/Pharmaceutical a distinct advantage
• Strong verbal and written communication skills, Microsoft excel, word, power-point etc.
• Strong Competence in IT systems
• Strong attention to detail
• Ability to multitask, manage time efficiently and prioritize effectively across multiple labs.
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target #LI-NJ1 #LI-Onsite

Travel Requirements