Associate Director/ Senior Manager, Manufacturing Technical Support (MTS)

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
Associate Director/ Senior Manager, Manufacturing Technical Support (MTS)

Position Summary

As the Associate Director / Senior Manager of the Manufacturing Technical Support (MTS) group in a growing and dynamic manufacturing team, you will use your passion, creativity and diverse industry experience to lead New Product Introduction (NPI) and process improvement projects at Tessa’s cell therapy manufacturing facility. You will lead and guide the team to establish excellent standards for manufacturing operations, GMP compliance, cleanroom operational efficiency, yield improvement, failure analysis, continuous improvement, while identifying opportunities for advanced process controls, cost reduction, and automation of unit operations together with MSAT, Product and Process Development, and other operational groups. You will also collaborate with other multi-disciplinary teams to maintain strong functional relationship to co-develop strategic and tactical plans to bring innovative cell therapy technologies into the clinic or for commercialisation.

With your passion for people management and focus on collective interest, you will guide, develop, and mentor your fellow colleagues to establish a highly collaborative, professional, and high performing team that delivers excellent results while establishing a positive and high energy workplace environment.

Responsibilities

New Product Introduction (NPI)

  • Lead and overall accountable for New Product Introduction (NPI) projects and successful technology transfer of cell therapy manufacturing processes into the facility.
  • Perform facility and process fit assessment, gap analysis, Failure modes and Effects Analysis (FMEA), CMC impact assessment, EHS risk assessment, others.
  • Author and generate high quality site-specific process documents such as Batch Records, Bill of Materials (BOM), Detailed Process Flow Diagrams (DPFD), Material Specifications (MS), Site Specific Process Description, APS Protocols, development / investigative protocols, and reports, etc.
  • Define training requirements, develop process training programs and materials, deliver pre-campaign process-related classroom and hands-on training to the Manufacturing team.
  • Perform and / or support mock runs or experiments in the development lab to support technology transfer (as required).
  • Ensures that technology transfer into the site has adequate manufacturing controls and executed in accordance to cGMP guidelines.

Technical Leadership and Process Support

  • Jointly with Site Leadership Team, participate in the development of manufacturing strategies, capacity planning, site strategic plans and objectives.
  • Lead and overall accountable for performing technical review and approval of process-related documents, change controls, deviation, RCAs, CAPAs, development / investigative protocols and reports, training documents, others.
  • Lead, assess and manage major change controls relating to process, equipment, utilities, or procedures that will impact product quality and process performance.
  • Lead cross functional teams to assess major and complex deviations that impact product quality. Perform root cause analysis and utilise Ishikawa tools (e.g. Cause-Effect, Control Chart, Pareto Chart, 5 Whys, FMEA, etc). Develop and identify thoughtful and appropriate CAPAs. Lead and coordinate implementation of CAPAs (where necessary).
  • Jointly with manufacturing to provide oversight of on-going trainings to ensure alignment between training and process requirements.
  • Provide process support on the shopfloor and troubleshoot issues jointly with manufacturing, MSAT and quality (where required).
  • Perform process monitoring for lot-to-lot consistency, author monitoring reports. Develop tools, techniques, and metrics, and dashboards for insights and data visualization. Present and share findings and process insights with management team.
  • Lead technical meetings relating to the manufacturing process, established knowledge management platforms, and conduct periodic technical and scientific training and knowledge sharing sessions to the operations team.
  • Lead and establish process technology implementation roadmap. Evaluate new manufacturing technologies, closed systems, and automation solutions for potential implementation to improve process performance. Develop and present proposal to Site Leadership Team and drive shopfloor implementation.
  • Work closely and collaboratively with process development, analytical development, MSAT, Quality, Regulatory, and R&D groups to achieve site objectives.

Continuous Improvement (CI)

  • Utilise Lean Six Sigma concepts and tools (e.g. DMAIC) to drive and identify areas for continuous improvement for production processes with the goal to achieve predictable delivery and quality treatments for patients while being cost effective.
  • Trends Key Performance Metrices and implement measures to streamline work processes and procedures.
  • Champion CI initiatives, facilitate and drive a continuous improvement mindset and culture. Encourage experimentation and learning through iterations.
  • Lead and successfully implement CI initiatives to improve operational performance (e.g. RFT, success rate, MUV, others) and cost improvement projects that has budget impact.

Leadership and People Development

  • Lead, manage, and build a highly collaborative, professional, and high performing team that will deliver excellent results while establishing a positive and high energy workplace environment.
  • Coach, mentor, and/or cross train colleagues in core technical areas. Structure training modules and curriculum for both new hires and existing staff to advance the technical competency of the operations team.
  • Perform performance appraisal, goal setting, talent development, succession planning and career mentorship for team members.
  • Proactively champion site safety and quality culture and mindset.

Requirements

Basic Qualification(s)

  • Bachelors / Masters / PhD in Immunology in Cell Biology, Molecular Biology, Chemical Engineering, Bioengineering, and other relevant scientific or engineering disciplines.
  • At least 8 years of biopharmaceutical manufacturing operations, process development, or process engineering experience.
  • At least 3 years in people management and leadership roles with demonstrated track record in leading, mentoring and developing high performing technical teams.
  • Excellent working knowledge of cGMP guidelines and relevant regulatory knowledge (FDA, EMA, PICS); Experience with Regulatory inspections is required.
  • Excellent knowledge of cell culture and principles of aseptic processing in a classified environment. Hands-on experience with primary cell culture.
  • Expert knowledge in electronic business reporting and quality systems (e.g. Trackwise, SAP, others).

Preferred Qualification(s)

  • Knowledge of T cell biology and immunology will be extremely advantageous.
  • Highly skilled in applying Ishikawa tools (e.g. Cause-Effect, time series, pareto analysis, etc) and in designing meaningful CAPAs.
  • Lean / Six Sigma experience and certifications is a plus.
  • Technical writing skills to support authorship of internal/external documents and approve technical documents.
  • Strong communication and interpersonal skills; ability to develop important relationships with key stakeholders, good conflict management and negotiation skills with strong ability to lead and drive cross functional teams.
  • Excellent attitude towards work, with strong drive to drive tasks to closure.
  • Excellent presentation and communication skills to communicate complex technical information.
  • Able to build and manage a team as well as train entry-level personnel.