Manufacturing Lead

3 weeks ago

Bengaluru, India Dr. Reddy's Laboratories Full time
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 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.

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