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.
As a Senior Biotechnologist, you will use your passion, strong GMP working knowledge and experience to work alongside a team of biotechnologist in the manufacturing of innovative T cell therapy products for the treatment of cancer patients in Tessa’s state-of-the-art GMP facility.
In this role, you will be responsible for planning, driving, and executing manufacturing activities in a cleanroom processing suite while ensuring operations are performed in accordance with safety and GMP requirements. Key activities include – providing weekly and monthly activity forecast, planning daily cleanroom activities, performing cell processing operations based on the batch manufacturing record and SOPs, and provide training and coaching of team members (as required).
In addition, you will also coach and foster a highly collaborative, professional, and high performing cleanroom culture that will deliver excellent results while establishing a positive and high energy workplace environment.
Manufacturing Cleanroom Operations
- 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.
- 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 management team.
- 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.
- Perform process monitoring, update, and maintain databases / spreadsheet / document to support management and business reporting.
- Technical owner and reviewer of manufacturing documents such as batch manufacturing records, SOPs, forms, and monitoring / log sheets whilst ensuring accuracy and compliance to cGMP and GDocP standards.
- Responsible for overseeing closure of batch record review and deviations write ups to ensure timely batch release of the final product.
- Author and / or update manufacturing SOPs. Ensure SOPs are technically sound, concise and structured, user friendly, operationally efficient, and are aligned to GMP requirements.
- Participate in cross functional teams to drive 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.
- Train new employees and coach existing employees.
- Support the team manager and lead biotechnologist to develop a high performing team in a manufacturing suite against the defined manufacturing KPIs.
- Lead and participate in the internal manufacturing tier meetings and discussions (as required).
- Responsible for aspects of daily cleanroom activities from resource planning, suite preparation to batch record sign-off.
- Champion a strong culture of Right First Time (RFT), low error rate and consistent GMP / cleanroom behaviour.
- Ensure the safety and productivity of all employees assigned to designated shift.
- Suggest and implement cost-savings ideas
- Strong demonstrated understanding of cell culture techniques, cryopreservation processes, purification methods, and sterile manufacturing operations is required.
- Degree in Biotechnology / Chemical Engineering / Bioengineering / Life Sciences or any related field.
- Minimum of 5 years in a GMP biopharmaceutical manufacturing related role.
- Applicant must be familiar with a GMP environment, fundamental quality systems (deviation, corrective action preventative action, change control, etc) and regulatory compliance expectations on manufacturing floor.
- Possessed strong knowledge on aseptic processing techniques including aseptic gowning. Experienced working in Grade B / A cleanroom environment.
- Experience in handling cell culture process. Experience in processing of human primary cells (e.g. T cells, MSC, others) will be advantageous.
- 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.
- Able to work independently with minimal supervision and direction.
- Experience in applying various Root Cause Analysis tools and designing effective CAPAs to address the identified Root Causes.
- Good analytical, planning and coordination skills to work in internal cross functional groups and external cross organizational working groups. Good communication and presentation skills are essential.
- Positive, high energy and possess a “can do” attitude to achieve personal, functional, and organizational goals.
- Experience in leading a high performing team as well as being a strong team player with demonstrated ability to build positive relationship with a strong set of interpersonal skills.
- 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.
- Proficient in MS Office Suite (Microsoft Word, Microsoft PowerPoint, Microsoft Excel).
- Excellent written and verbal communication skills.
- Able to work off hours, weekends, and non-standard shift on on-call rotation (where required).