Today, Lonza is a global leader in life sciences operating across five 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.
The role:
We are seeking a highly skilled Cell Culture Process Development Lead Scientist with expertise in cell culture process development and characterisation, statistical analysis, and data-driven decision-making. The successful candidate will lead matrix teams to execute lab work across different development stages while collaborating with clients in a customer-facing role.
As a Lead Scientist in Cell Culture Development, you bring proven technical expertise and scientific acumen in specialised areas, with a strong track record of managing multiple complex projects concurrently. You are adept at building and expanding technical and scientific capabilities while mentoring and training junior scientists. In addition to meticulous project planning and execution, you engage in hands-on laboratory work with a high level of Right-First Time (RFT) delivery and actively contribute to customer interactions as part of internal and external project teams. A key player in laboratory operations, you take a leadership role in maintaining lab efficiency and ensuring compliance with operational standards.
Key responsibilities:
Lead process characterisation and technology transfer studies related to cell culture development for successfully delivering projects of increasing complexity.
Manage and guide matrix teams to conduct lab work across multiple stages of process development.
Efficiently manage personal and team workflows to meet project goals with minimal supervision.
Conduct risk assessments based on Failure Mode and Effects Analysis (FMEA) to identify the process parameters for experimentation and to qualify the design space.
Engage in routine mammalian cell culture workflows involving media preparation, revival, and subculture as required for an experiment.
Design and implement experimental studies using Design of Experiments (DOE) methodologies. (e.g. DOE in 250 mL and 10 L scale bioreactors for process characterisation stages)
Document the study results and analyse the data using Excel, JMP, Design Expert, or Minitab to interpret experimental results effectively.
Collaborate with customer technical representatives, serving as the primary technical point of contact for process characterisation projects.
Develop and deliver technical presentations summarising study findings to internal teams and external customer project teams, including direct communication and external presentations.
Prepare and review study protocols and reports, supplementary data reports, ensuring compliance with regulatory and quality standards for management review and review communications from junior team members.
Build and maintain a network of contacts on-site and globally to support project objectives.
Key requirements:
PhD, MSc or equivalent experience with progressive experience in cell culture techniques and cell culture process development and characterisation.
Experience in CHO cell line optimisation, bioreactor scale-up/scale-down, and process characterisation for biopharmaceutical production
Experience in Cell culture, Cryo preservation, Revival of cell line, mycoplasma testing, cell counts by using Vi-Cell XR and Vi-Cell Blue, Media preparation, feed preparation, following good aseptic technique
Proven experience in cell culture process development and characterisation studies.
Strong knowledge of DOE methodologies, small-scale model qualification, and risk assessments (using C&E and FMEA tools) for process characterisation studies.
Familiarity with biologics drug development involving cell line construction Gene to IND to BLA filings and cGMP regulations for developing the large molecule.
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.