Manufacturing Lead

Job Description

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

• Support the building of a cGMP CAR-T therapy facility and associated functions. 
• Contribute to the design and implementation of efficient and scalable manufacturing processes and for commercialization. This includes the assessment of automated manufacturing systems and digital data systems.
• Drives continues improvement activities and operational excellence including reduction of cost of goods and commercial robustness/reliability.
• Hire, mentor, and train a top-performing Manufacturing team. 
• Oversee and lead the production of cell therapy products in a regulated, cGMP cleanroom environment, following SOPs and Batch Records. 
• Support the development of SOPs and Batch Records, Risk assessments as well as the Tech Transfer of new procedures to other sites. 
• Manage the production shift schedules and the Manufacturing Operators daily activities.
• Manage the CAR-T facility equipment Calibration, Validation, and Maintenance Plans.
• Manage process APS, Engineering batches demonstration and validations for multiple projects.
• Establish process and patient centric control strategy (CPPs, quality attributes etc) for in-process, final product and stability assessments.
• Review completed production batch records and assist with deviations, CAPAs, Change Controls, and investigations. 
• Ensure that production activities comply with safety and quality policies, as well as cGMP criteria. 
• Collaborate with other stakeholders/managers and departments on-site, as well as colleagues from different groups. 
• Develop and implement metrics/KPIs to monitor operational health, inform strategic decisions.
• Develop and manage budgets for projects and be accountable for delivering against business goals/objectives

Qualifications

Ph.D. degree or Master's degree or Bachelor's degree in Biology, Chemical Engineering, Microbiology, Biotechnology with 10 - 15 years of experience in working on Cell and Gene tharapy (CAR-Ts) and Biological Products.

Additional Information

Experience Required:

• Proven experience as a direct manager or lead in cGMP Manufacturing of cell (CAR-T) therapy products. 
• Experience in aseptic processing in GMP classification and cell culture is required. Experience in automated equipment for cell culture, washing, and cryopreservation is preferred. 
• Working knowledge of cGMP regulations and FDA guidance for cell therapy manufacturing. 
• Positive interpersonal skills with the ability to interact with individuals from a variety of levels and function. 

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.