Analytical Lab Manager

Key Responsibilities

• Demonstrate a primary commitment to patient safety and product quality.
• Maintains a full understanding and complies with all the regulations governing the quality system. Responsible for the maintenance and continuous improvement of the Quality System for the analytical laboratory compliant to FDA, GMP, ISO, and European directives.
• Delivery of key Quality and Performance Objectives.
• Ensures that all direct reports are aware of their commitment to patient safety and product quality, are up to date with their training requirements and they understand and comply with all other regulations governing their work.
• Site responsibility for the maintenance and continuous improvement of the operations laboratories supporting Chemical, Microbiological, Mechanical, Stability and Dimensional testing.
• Supervision of the transfer of validated analytical methods into laboratory from donor laboratories.
• Management of the day to day activities of the Operations Laboratories to ensure timely execution of testing, review, approval and release of results.
• Final review and approval of all laboratory results, protocols, reports, SOPS etc.
• Selection, approval and on going monitoring of Contract laboratories.
• Provide technical guidance /trouble shooting in the event of equipment failure, out of specification results, method issues.
• Management of Product Annual Reviews from a Laboratory perspective.
• Co-ordinates the development of Laboratory staff.
• Familiar with the internal and External auditing processes.
• Selection and recruitment of Laboratory staff as required in conjunction with Human Resources.
• Understands and proactively follows through on the Environmental Management Procedures that have been identified as relevant to position.
• Maintains knowledge of method validation and subsequent transfer to other sites.
• Manages the budgets for the various operations laboratories.
• Ensure that the implementation of the change control procedure are in conformance with the required standards.
• Ensures that NCEP’s and eCAPA’s are investigated to determine root cause and that appropriate corrective actions are applied. Ensure that all NCEP and eCAPA are completed as within the time defined by corporate.
• Contributes to site management operational and strategic initiatives.
• Ensures Performance reviews of staff are conducted and are effective.
• Supports plant validation and process improvement activities.
• To establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area.
• Ensure employees are trained to do their work and their training is documented.
   

Requirements

• Minimum Bachelor of Science in Analytical Chemistry, Chemistry or Analytical Instrumentation.
• A minimum of 8 years of experience in a pharmaceutical or commercial analytical testing laboratory is required, along with at least 5 years of experience managing laboratory resources or chemists.
• Experience working in an ISO-compliant lab or under medical or pharmaceutical controlled regulations will be an added advantage.
• Proficiency in Analytical Test Method Validation and Test Method Development is required. Additionally, candidates should have skills in operating analytical equipment and instrumentation, including HPLC, GCMS, and UV. Experience working with enterprise software systems for analytical laboratories is also essential.
• Preferably a certified Chemist.

About Us

As a global medical technology leader for more than 40 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.