Biotechnologist Lead

Company Background

Tessa Therapeutics is a clinical stage biopharmaceutical company with the scientific vision of revolutionizing the treatment of cancer by redirecting the body’s potent anti-viral immune response to recognize and kill cancer cells. Tessa’s core virus-specific T Cell (VST) platform has shown compelling results in the treatment of solid tumors, and the company is building a portfolio of therapies addressing a wide range of tumors by combining the qualities of its T cell platform with complementary technologies. Tessa’s lead Phase III trial for nasopharyngeal carcinoma (NPC) is the world’s largest Phase III T cell immunotherapy trial for any cancer indication. The company has built up robust operational and supply chain capabilities to successfully deliver autologous T cell therapy treatments to a large patient pool across five countries. The combination of technologies from its academic, clinical, and commercial research partners have enabled the company to create a fully-integrated approach to the treatment of cancer with immunotherapy.

Our mission is to cure cancers and save lives with our innovative and widely accessible immunotherapies.

We are looking for highly motivated and enthusiastic individuals who are interested to be part of our Manufacturing team.

 

Job Position
Senior Biotechnologist/Lead

Reports to
Manufacturing Manager

Location
Malaysia

Position Summary

As a senior biotechnologist, you will use your strong GMP working knowledge and experience to lead and work alongside a team of up to 5 biotechnologists in the manufacturing of autologous T cell therapy products. You will be responsible for planning and driving the execution of manufacturing activities in a cleanroom processing suite, including – providing weekly and monthly activity forecast, planning daily cleanroom activities and ensure the team is focused in execution of these activities.

You will lead and motivate the team to ensure excellence standards of manufacturability, cleanroom operational efficiency while being compliant to GMP requirements. You will foster a highly collaborative, professional and high performing cleanroom culture that will deliver excellent results while establishing a positive and high energy workplace environment.

Responsibilities

Manufacturing Responsibilities

  • Production of autologous T cell products from venesected blood through cell culture, harvest, and cryopreservation;
  • Observe strict aseptic practices for cell culture and other cleanroom related activities to ensure compliance to current Good Manufacturing Practice (cGMP) at all times;
  • Records manufacturing data and information in a clear, concise, format according to Good Documentation Practice (GDP);
  • Clean and maintain facility, clean room and equipment;
  • Lead and participating in manufacturing meetings and discussions (e.g. daily production team meeting)
  • Adheres to the production schedule ensuring on-time, internal production logistics;

Team Lead Responsibilities

  • Lead a team of biotechnologist to ensure smooth execution of cleanroom operations and to meet production schedule;
  • Responsible for all aspects of daily cleanroom activities from resource planning, suite preparation to batch record sign-off;
  • Technical owner and reviewer of batch records, SOPs, forms, and monitoring/log sheets while ensuring accuracy and compliance to cGMP and GDP standards;
  • Responsible for overseeing closure of batch record review and deviations to ensure timely batch release;
  • Support deviation reporting, RCA and CAPAs and manages their timely closure (when applicable);
  • Ensure appropriate maintenance of manufacturing facility, cleanroom and equipment;
  • Ensure high level cGMP compliance and integrity;
  • Champion a culture of right first time, low error rate and consistent GMP / cleanroom behaviour;
  • Drives improvements in departmental processes, quality and right first time;

People Development

  • Lead and develop a high performing team in a manufacturing suite;
  • Set personal development goals and provide coaching, mentorship and performance feedback;
  • Monitor training and development status and requirements of individual team members.

Qualification(s)

  • Bachelor’s degree in relevant life science and engineering disciplines;
  • Minimum 6 years of relevant cell therapy (or biologics) commercial manufacturing experience and at least 2 years of experience leading a manufacturing team;
  • Strong understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique is mandatory;
  • Strong working knowledge of GMP guidelines and manufacturing processes;
  • Knowledge in electronic business reporting and quality systems (e.g. Trackwise, SAP).

Preferred Qualification(s)

  • Prior experience with primary cell culture;
  • Experience in applying Root Cause Analysis tools and in designing meaningful CAPAs;
  • Possess technical writing capabilities;
  • Proficient in MS Office Suite (Word, Powerpoint, Excel);
  • Excellent written and verbal communication skills;
  • Strong team player with demonstrated ability in positive relationship building and interpersonal skills;
  • Able to lead and manage a team as well as train entry-lvel personnel.