Senior Medical Laboratory Scientist (Team Lead), NCIS

Overview

NCIS is establishing a new Stem Cell Therapy Hub (SCTH) as part of expansion of its Specialised Programmes (specifically Cellular Therapy and Haematopoietic Stem Cell Transplant) and to become a Reference Centre of Excellence. We are looking for a Medical Laboratory Scientist (Team Lead - Cell Therapy, GMP) who will be responsible for assisting the Head, Cellular Therapy in the supervision and manufacturing operations of Gene Therapy (CTGT) Product. He/she will lead and manage the execution of internal or external cell therapy projects such as technical method transfer. He/she will lead and mentor junior staffs, work closely with other functional units and undertake administrative tasks to always ensure smooth lab and manufacturing services.

Job Responsibilities

• Executes manufacturing and assist with the management of the GMP/clinical manufacturing suites and oversee all manufacturing operations.
  • Lead the technical transfer of development projects to GMP/clinical scale manufactures, working closely with the engineering and technical teams
  • Write technical specifications for equipment, services and consumables, plan and submit inventory requisitions for general consumable and batch specific items.
  • Identify areas of improvement across operational functions and build business cases to improve the processes and systems in the facility
  • Responsible for proper information sharing and ensure all issues are communicated appropriately.
  • Periodically inspect product to ensure quality levels are maintained.
• Coordinate production events with the relevant technical teams and departments.
  • Follow and apply Good Manufacturing Practice and maintaining of the Quality Management Systems.
  • Maintain and review of quality documentation and SOPs, to perform and record cleaning of process equipment and facility in accordance with relevant documentation and procedures
  • Ensure adequate status of supplies and equipment for successful execution of GMP/clinical manufacturing runs.
• Collaborate with Quality Team to support the execution of Deviations, Root Cause Analysis and CAPAs.
  • Initiates / investigates deviations, develops and implements corrective and preventative actions as required.
  • Leads and/or actively participates in troubleshooting.
  • Serves as possible SME for audits.
• Act as a point of contact for team members’ queries and escalations with regards to any technical transfer project and or facility/equipment issues within the facility.
  • Troubleshoot manufacturing processes and propose needed protocols for data collections and/or experimentation
  • Provide technical training of co-workers on all SOPs, processes and lab/manufacturing techniques
  • Clearly communicate instructions and operational expectations to team members
  • Observes performance of employees, provides timely and targeted coaching for employees
  • Complete all documentation and training as required.
  • Assist in authoring and/or revising SOPs and work instructions as needed.
  • Ensure safety guidelines are followed by all team members.
  • Serve as a subject matter expert in area.
• Maintain consistent and documented compliance with all relevant workplace safety and health, good manufacturing practice, good documentation practice and relevant local and international legislative requirements.
  • Ensure the required quality and safety standards are achieved and maintained with respect to operating procedures, all batch manufacturing documentation, area housekeeping.
• Support the development of scheduling systems and tools of the operational areas scheduling and planning for the routine upkeep of the facility.
  • Work with other groups for requirements relating to quality systems, safety, facility maintenance, utilities maintenance & availability, equipment engineering & maintenance, validation, and warehousing for materials /product storage.
  • Assist with coordinating the daily activities, ensuring cleaning, environmental monitoring and maintenance schedules are up to date and maintained.
  • Assist in managing the third-party cleaning service provider and ensure cleans are carried out to a high compliant standard with logbooks and relevant documentation completed.
• Accountable for ensuring procedures across the facility are compliant and tailored to business and collaborator needs.
• Generate, review, and approve documentation such as Standard Operating Procedures, batch records, cleaning schedules, non-conformance reports, out of specification results.
• To participate in any other tasks that are deemed a priority for the site by Management that you are able and trained to perform.
• Participate in laboratory administrative work such as filing, processing of deliveries orders and invoices.
• Evaluate new laboratory test methodologies and instrumentation.
• Assist with the requisition of capital equipment.
• Participate and contribute to departmental meetings and project teams as required.
• Any other duties as assigned by supervisor.

Requirements

• Bachelor’s Degree in Engineering (Chemical / Biomedical), Biotechnology, Life Science or equivalent. Master’s Degree or PhD will be considered an advantage.
• 5 to 10 years of relevant experiences in biopharmaceutical and/or medical device manufacturing industry and prior technical knowledge in batch biopharmaceutical processing will be an advantage
• Track record of technology transfer of processes for the production of cell, tissues and gene therapy products
• Project management experience
• Possess significant, technical expertise in cell, tissues and gene therapy
• Significant and practical experience of good manufacturing practices (GMP) and quality system concepts
• Good understanding of cGMP, and HSA Guidance, ICH Guidelines and CMC content of regulatory submissions
• Demonstrated ability to elevate issues effectively and apply appropriate corrections.
• Highly motivated, proactive, and enthusiastic team player with demonstrated history of flexibility
• Ability to work independently, collaborate cross-functionally, and utilize resources efficiently
• Able to provide feedback for operations & elevate concerns as needed.
• Excellent organizational, interpersonal, verbal, and written communication skills.
• Good laboratory skills.
• Above average dexterity with good general health and must be able to differentiate colors for work purposes.
• Basic computer literacy.
• Good planning and organizing skills.
• Good communication and interpersonal skills.
• Service orientated and customer focused.