Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
As an experienced subject matter expert, you will participate in a high performing, cross-functional team supporting the development and optimization of cell culture processes for the production of cell and gene therapy products. The successful candidate should have experience with primary cell and tissue isolation techniques, maintenance, expansion, and differentiation of stem cells including pluripotent stem cells, in vitro culture of T cells and/or primary cells derived from human tissue, in vitro culture of adherent and suspension cell lines, gene modification and transfection / transduction techniques, downstream and fill/finish processing.
You should be able to assist both technical scientists and management in the design and execution of new or unique cell-based projects; be able to assist with tech transfer of processes to manufacturing and design of investigation studies for MSAT and manufacturing team; be able to train and mentor other technical scientists and manufacturing personnel in the development and / or execution of developed process plans; analyze bioprocessing data to monitor, optimize and determine limits of process performance. You should be able to present data and clearly communicate the results of development studies with the clients.
- Responsible for successful development and execution of state-of-the-art Bioanalytical methods supporting cGMP manufacturing within the Cell Therapy Development matrix
- Interact with new or existing Cell and Gene Therapy clients to document and transfer new assays to Lonza sites and communicate and present the work in internal and client meetings.
- Contribute and support scientific or engineering expertise toward the design and development of new ideas that support client product concepts
- Support the discussions around definition of scope of development work and resource planning
- Design, review and execute experiments of assay optimization, qualification and validation, trouble shoot the problems.
- Understand cell-based assays including, but not limited to, morphological assessment, cell proliferation, functional differentiation, cytotoxicity, detection of marker expression (ICC), Flow Cytometry, qPCR and ELISAs. Master as an expert at least two analytical technology platforms.
- Oversee the initial technical training of specific analytical protocols to the QC Teams.
- Lead project team in the development and can guide and coach people
- Establish and maintain a good working relationship within the operations department and other departments such as Research and Development (R&D), Quality Control (QC), Manufacturing (Mfg), Quality Assurance (QA) and Project Management (PM)
- Review and/or train/assist in writing and revising technical documents including laboratory SOPs, protocols, reports and batch records
- Support Research and Development (R&D) projects by providing constructive technical feedback and improving new methods as they are being transferred into Cell and Gene Therapy Development prior to offering to clients
- Perform other duties as assigned.
- PhD in Life Sciences with focus on biology or Bioengineering with working experience; or MS degree in Life Sciences field with significant experience of related manufacturing or process development experience in Biotech industry.
- Experience and expert knowledge of analytical methods and in process controls commonly used in manufacturing processes such as cell count viability, flow cytometry, immunoassays and molecular biology techniques.
- Practical knowledge of GMP requirements for assay design, qualification and validation.
- Knowledge and experience with variety of cell culture systems and optimization of cell expansion and differentiation process for GMP manufacturing.
- Self-directed and self-motivated; demonstrated ability to work both independently and also as a team member in a matrix environment; maintains a positive approach to setbacks and challenges; champions new ideas and initiatives; brings out and utilizes others' creativity to improve team performance
- Client oriented: establishes effective and responsive relationships with all clients; able to translate client projects into a feasible process design; known to ensure value is always delivered to the client
- Exceptional oral and written English communication skills
- Excellent computer software skills related to Microsoft office and data analysis; capable of keeping professional, accurate and timely records of all essential activities; able to manage multiple projects; excellent time management skills
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.