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Senior Manufacturing Biotechnologist

Job Title: Senior Manufacturing Biotechnologist

Job description:

Lion TCR is a Singapore-based clinical stage T cell immunotherapy company focusing on development of T cell receptor (TCR)-T cells immunotherapy against viral-related cancers. Our core immunotherapy technology platform involves developing and commercializing TCR-T cell products against viral-related cancers, of which the leading product candidate is against hepatitis B virus related hepatocellular carcinoma and chronic hepatitis B virus infection. Our strategic objective is to build a global oncology business with an extensive portfolio of engineered TCR therapeutic candidates that have the potential to significantly impact the clinical outcomes of patients with cancer.

We are seeking a highly motivated and self-driven Senior Manufacturing Biotechnologist to join the Manufacturing Department. You will report directly to the Manufacturing Biotechnologist Lead and Manufacturing Director. You will be in charge-of the manufacturing of human cell therapeutic products. This includes work relating to the preparation of raw materials, buffer solution, process equipment, and the manufacturing of specialized TCR-T cells. As a Senior Manufacturing Biotechnologist, you will also be given opportunities to lead projects related to manufacturing process, manufacturing warehouse and cleanroom improvement projects.

Key responsibilities:

• Production of TCR-T cells according to production order.

• Complete the production batch record and equipment usage record.

• Maintain and calibrate production related equipment regularly.

• Plan and prepare production raw materials and consumables, ahead of production order.

• Assist in the purchase of production materials.

• Drafting and revising of production related documents.

• Maintain cleanliness of all production equipment.

• Maintain the cleanliness of production area and cleanroom ancillary areas.

• Draft, review and ensure the completion of CAPA and Deviation Report.

• Assist in the preparation for GMP inspection.

• Perform process and equipment validation activity.

• Identify gaps in manufacturing process and propose solutions and improvement.

• Assist in training of new manufacturing biotechnologists in gowning, cleanroom behaviour and other manufacturing related processes.

• Assist in technology transfer of manufacturing process to other manufacturing sites overseas.

• Complete other ad-hoc work arranged by Manufacturing Team Lead and Director.

Qualifications:

• A Diploma or Bachelor’s degree in Life Science, Biological Science or the equivalent.

• Experience with primary human cell culture and aseptic techniques is required.

• Candidates with prior experience working in cell therapy manufacturing preferred.

• Knowledge of GMP processes and requirements and local regulatory requirements would be advantageous.

• Flexibility to work in other manufacturing sites overseas for short-term period for technology transfer and training.

• Comfortable in a fast-paced environment and able to adjust workload based on changing priorities of the company.

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