- To perform hands-on laboratory work in the cell culture process development team contributing to the development of processes suitable for technology transfer to the cGMP manufacturing teams. An understanding of cGMP manufacturing facility constraints and their impact on development activities will be developed.
- Contribute to Process Validation / Process Characterization activities by perform and/or supporting laboratory scale studies, employing QbD concepts and DoE methodologies.
- Data analysis and interpretation to define critical process parameters and operational ranges under supervision . The use of statistical software will be required for Process Validation/ Characterization activities.
- Acting as a cell culture SME supporting the lead scientist in process risk assessment, e.g. Failure Mode and Effects Analysis (FMEA).
- Deliver high quality communication to ensure an outstanding customer experience (written documents, technical justifications, telecons, face to face meetings). Working as part of a site and global project team, co-ordinate multiple projects and ensure timely delivery of project work stages.Cell culture hands on work include scale down model qualification, primary harvest, process parameter screening, NOR&PAR finding, defining control strategiesusing shake flasks, bench scale (10L) bioreactors, depth filters, robotic bioreactor system (Ambr250), and etc.
- To work to the highest scientific standards under the direction of the Line Manager.
- To communicate project updates to internal and external customers.
- To contribute to the efficient running of the department including instigating and delivering operational efficiency projects.
- Contribute to departmental safety and training programs as required.
- Dependent on scale of project, supervision of project teams may be required.
- The role may require occasional weekend work.
- Degree/PhD in a relevant Science field or Equivalent.
- Minimum 5 years' work experience in relevant field or PhD with 2 years postdoctoral experience.
- The final role offered will be commensurate with the candidate's experience.
- Understanding of theory and application of mammaliancell culture.
- Practical laboratory experience in robotic bioreactor system operation is highly advantageous.Understanding of cGMP regulations will be advantageous.
- Prior experience in the use of statistical software or good statistical knowledge will be advantageous.
- Prior experience in facility fit assessment, process risk assessment, or good QbD knowledge will be advantageous.Good problem solving and analytical skills.Good communication skills (verbal and written).
- Good technical writing skills and team player
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Senior Scientist, Cell Culture Development - Singapur, Singapore - Lonza
Description
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.
Did you know that we are the 1st biologics contract manufacturer in ? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.
The successful applicant for this position will be joining Cell Culture Development team in Lonza Singapore. This group is responsible for the development and characterization of manufacturing processes used for the production of novel therapeutic recombinant proteins for Lonza's global client base. The purpose of this role is to support lead scientist inprocess development and characterization activities (BLA studies) and to provide technical expertise to support troubleshooting activities at both laboratory and manufacturing scale.
Key responsibilities:
Key requirements:
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.
Reference: R59444
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