Biotechnologist

Job Position
Biotechnologist

Position Summary

As a Biotechnologist, you will work in a high performing and collaborative manufacturing team to deliver innovative T cell therapy products for the treatment of cancer patients in Tessa’s state-of-the-art GMP facility.

You will be responsible to support manufacturing activities in a cleanroom processing suite while ensuring operations are performed in accordance with safety and GMP requirements. Key activities include – performing cell processing operations based on the batch manufacturing record and SOPs, drafting of manufacturing related documents to meet production KPI and schedules.

This position provides a great opportunity to develop your career in different technical areas within biopharma operations. Training and continuous assessment will be provided. Successful applicants are expected to be on a production shift work and weekend/public holiday work rotation as required.

Responsibilities

Manufacturing Cleanroom Operations

• Complies with site EHS standards and requirements.
• Adhere and execute manufacturing shopfloor operations against the production schedule.
• Produce autologous/allogeneic T cell products in accordance with the Batch Manufacturing Record (BMR). Perform cell processing unit operations such as cell separation, activation, transduction, expansion, harvest, fill and finishing, cryoprotection, etc in Grade B and C cleanrooms.
• Participates in Aseptic Process Simulations and Environmental Monitoring unit operations as required.  Perform media preparation, kitting of consumables, in-process testing samples submission, irradiation, label printing etc.
• Operate, clean, maintain, and monitor the use of the GMP Facility, cleanroom, and cell processing equipment. Troubleshoot and communicate issues to lead biotechnologists.
• Observe strict aseptic and sterile manufacturing practices for cell culture and other cleanroom related activities to ensure compliance to current Good Manufacturing Practice (cGMP).
• Record manufacturing data and information in a clear and concise format in accordance with Good Documentation Practice (GDocP) and fundamental data integrity principles.
• Draft manufacturing documents such as batch manufacturing records, SOPs, forms, and monitoring / log sheets whilst ensuring accuracy and compliance to cGMP and GDocP standards.
• Participate in cross functional discussions to support non-conformance investigations – root cause analysis, impact assessments and closures. And where applicable, to implement appropriate and effective Corrective and Preventative Action to prevent recurrence.
• Develop comprehensive safety risk assessments and adhere to all environment, health, and safety (EHS) and support EHS initiatives to build a strong safety mindset on the manufacturing floor.
• Participate and support internal manufacturing tier meetings and discussions (as required).
• Exhibit Right First Time (RFT), low error rate and consistent GMP / cleanroom behaviour.
• Suggest and implement cost-savings ideas.
• Conduct trainings for new employees when required.
• Other duties as assigned.

Requirements

Qualification(s)

• Degree/Diploma in Biotechnology / Chemical Engineering / Bioengineering / Life Sciences or any related field.
• Possess good aseptic techniques and familiar handling cell culture process.
• Prior knowledge in Good Manufacturing Practices (GMP), aseptic processing, as well as, working within a classified environment is a plus.
• Prior experience with cell therapy products is a plus.
• Proficient in MS Office Suite (Microsoft Word, Microsoft PowerPoint, Microsoft Excel).
• Good analytical, planning and coordination skills to work in internal cross functional groups and external cross organizational working groups.
• Strong communication and interpersonal skills are essential.
• Strong teamwork-oriented work ethic.
• Able to stand and work long hours in cleanroom environments.
• Able to work independently with minimal supervision and direction.
• Professional, passionate, self-motivated, flexible, and willing to learn.
• Attention to detail.
• Team player.

Preferred Qualification(s)

• Familiar with six sigma, lean manufacturing principles and other process improvement tools will be an added advantage.
• Strong technical writing abilities with experience in writing SOPs or any other similar technical documents and with a good working knowledge of GMP.
• Cross functional experience in a supporting department within the biopharmaceutical manufacturing operations such as Quality Assurance, Quality Control or Supply Chain.
• User experience with applications such as SAP and Trackwise.
• Excellent written and verbal communication skills.
• Able to work off hours, weekends, and non-standard shift on on-call rotation (where required)