MSAT Lead

We are looking for a highly motivated MSAT lead to assist the manufacturing, PD, critical material attributes & supply and QC operations at a cutting-edge multi-product cell therapy manufacturing facility that will produce autologous and allogeneic cell therapy products.

This individual will collaborate with various functions to enable the production of cell therapy products using safe and compliant manufacturing processes that adhere to cGMP criteria. This individual will oversee cell process engineering, manufacturing support, technology transfer, validation, and cell therapy and analytics automation, as well as provide technical and continuous improvement support to ensure reliable production, testing, and timely release of cost-effective, compliant, and high-quality cell therapy products. As a result, the post will necessitate demonstrated leadership to ensure efficient communication, coordination, and collaboration among appropriate cross-functional groups.

This is a multidisciplinary function that requires the ability to interact with all levels of the organization, including Manufacturing, In-Process analytics, Quality Control & Quality, Material/Product Supply chain, Engineering/Facilities, Health, Safety, and Environment.

• Provide technical leadership for the design, commissioning, validation, and management of a cell therapy manufacturing site with multiple cell therapy products.
• Lead cell therapy product life cycle management for drug products and GMP manufacturing systems in the plant.
• Lead, direct, coach, and establish an effective MSAT team to support clinical production in a cutting-edge multi-product cell therapy manufacturing facility.
• Provide technical and management leadership by effectively interacting and cooperating with key stakeholders and functions within the organization to successfully manufacture and deliver products to patients in a timely manner.
• Oversee several department projects to create continual improvements and efficiencies within cell therapy.
• Build and maintain systems that continually monitor, analyze, and optimize process performance, as well as support and own quality events such as change controls, investigations, and CAPAs.
• Oversee the hiring, development, and performance management of employees at MSAT.
• Lead and actively engage in the facility's regulatory and internal audits.
• Work collaboratively with other functional divisions to establish and execute the strategic strategy for the manufacturing site.
• Lead cross-functional teams at and above site to enable effective collaboration.
  

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 therapy (CAR-Ts) and Biological Products.

Experience & Technical Skills required

• Minimum of 10 years of experience in a cGMP environment in the cell therapy/biopharma business, specialising in MSAT, and technical operations.
• The ideal candidate has cGMP manufacturing experience in cell/gene therapy, including tech transfer, process validation, project management, and change management. CDMO experience is preferred.
• Excellent project management and technical problem-solving skills. Must possess a passion for continuous improvement in accountable areas.
• Expert knowledge of global cell therapy and logistics, along with a comprehensive understanding of facility/clean room architecture, process, equipment, automation, and validation.
• Experience leading quality and regulatory inspections (e.g DCGI (CDSCO), USFDA and EU).
• Strong leadership skills with the ability to work in a dynamic environment and adapt their style to get along with all levels of management and stakeholders.
• Strong communication skills, both verbal and written.
• Knowledge of Lean best practices and cGMP.

Behavioural skills:

• Leadership: Effectively lead and motivate a team of MSAT to achieve departmental goals and objectives.
• Communication: Clearly communicate with team members, other departments, and management to ensure efficient workflow and collaboration.
• Problem-Solving: Ability to analyze complex manufacturing science/processes and technology issues and develop effective solutions to ensure accurate testing and compliance with regulations.
• Decision-Making: Make clear and timely decisions to address challenges and drive the department towards success.
• Teamwork: Collaborate with colleagues and cross-functional teams to achieve common objectives and improve processes.
• Time Management: Prioritize tasks, meet deadlines, and ensure timely completion of projects while maintaining quality standards.