Microbiology Lead

We are currently seeking an experienced Microbiology Lead who can assist in establishing our CAR-T manufacturing GMP facility, building a microbiology team, and managing and supervising production and QC microbiology activities. The ideal candidate should have prior experience in producing biologics and cell therapy products in a cleanroom environment under cGMP regulations. 

• Lead and design the overall microbiology operations of site GMP manufacturing operations, as well as ensure that the laboratory is performing to its best and in compliance with all regulatory agencies while aiming towards continuous improvement.
• Responsible for preparing lab layout, procuring and qualifying lab equipment, and validating software to comply with regulatory standards. 
• Prepare and execute microbiology method validation protocols (e.g., sterility, mycoplasma, endotoxin), equipment qualification, CSV, etc.
• Lead and execute clean room qualification, aseptic process simulation qualification, clean room maintenance, and risk assessments as per corporate QMS/regulatory requirements, etc.
• Serve as an Internal subject matter expert and support regulatory audits.
• To develop EMP for cleanroom monitoring and ensure sterile operation compliance.
• Lead laboratory investigations OOS/OOT/OOL and conduct root cause analysis
• Recruit, coach, and qualify the microbiology team in critical testing methods.  
• Prepare SOPs and documents to comply with regulatory requirements.
• Develop a disinfectant program/maintenance strategy for the clean room.
• Implement safe working conditions and practices in a laboratory. 
• To prepare CAPEX and OPEX budget of the laboratory and adhere to the budget.

Ph.D. degree or Master's degree or Bachelor's degree in Biology, Microbiology, Biotechnology with 10 - 15 years of industrial experience.

     Experience Required:

• Experience of a minimum 10 – 15 years in a regulated industry of biologics, cell and gene therapy, including people management experience.
• Experience of environmental monitoring and bacterial endotoxin testing
• Familiarity and understanding of FDA, EU, and local industrial requirements.
• Evidence of an acquired solid background of technical knowledge and experience, plus successful direction of significant projects
• An ability to work independently as well as a member of a team in a dynamic, fast-paced environment is essential

     Behavioural   skills:

• Leadership:  Effectively lead and motivate a team of scientists and associates to achieve departmental goals and objectives.
• Communication:  Clearly communicate with team members, other departments, and management to ensure efficient workflow and collaboration.
• Critical Thinking:  Evaluate data and information critically to make informed decisions and optimize commercial processes.
• Decision Making:  Make clear and timely decisions to address challenges and drive the Manufacturing department towards success.
• Problem-Solving:  Ability to analyse complex manufacturing issues and develop effective solutions to ensure accurate testing and compliance with regulations.
• Teamwork:  Collaborate with colleagues and cross-functional teams to achieve common objectives and improve processes.