Senior Manufacturing Biotechnologist
3 days ago
**Job Title**: Senior Manufacturing Biotechnologist
**Job description**:
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.
- 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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