Manufacturing Lead - Bengaluru, India - Dr. Reddy's Laboratories

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
  
  

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

Experience Required:

• Proven experience as a direct manager or lead in cGMP Manufacturing of cell (CAR-T) therapy products.
• Experience in aseptic processing inGMP classificationand 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.

Behaviouralskills:

• 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.