Biotechnologist Jobs

Tessa Therapeutics Pte Ltd

Job Brief

We have a vacancy of Biotechnologist in our company, Tessa Therapeutics Pte Ltd. This vacancy is based in Singapore. Please go through the job detail mentioned below.

Position Title: Biotechnologist
Company: Tessa Therapeutics Pte Ltd
Work Type: Full Time
City of work: Singapore
Salary: Salary detail is not available
URL Expiry: 2022-08-12
Posted on: https://sg.jobsoffices.com

Job Detail

Company Background

Tessa Therapeutics is a clinical-stage biotechnology company developing a portfolio of next-generation cell therapies for cancer. It has a pipeline of therapies in clinical development for the treatment of hematological malignancies and solid tumors.

Tessa’s lead autologous therapy is in late-stage clinical development for treatment of lymphomas. It has shown strong clinical responses in patients with relapsed/refractory classical Hodgkin lymphoma, based on which it was granted the RMAT designation by the U.S. FDA and the PRIME designation by EMA.

Tessa is also developing a novel, differentiated, allogeneic “off-the shelf” cell therapy platform to create more efficacious, reliable, and scalable therapies capable of targeting a broad range of cancers. A therapy using this platform is being evaluated in an ongoing clinical trial in United States.

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)