- Perform hands-on laboratory work in the purification 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.
- Process Characterization activities including Risk Assessment (FMEA), employing DoE methodologies, data analysis and interpretation to define process parameter ranges and process steps.
- Draft technical documents- Protocols, reports, SOPs etc for review.
- Be the project representative delivering high-quality communication to ensure an outstanding customer experience (written documents, telecons, face to face meetings).
- Working as an integral part of a site and global project team, co-ordinate multiple projects and ensure timely delivery of project work stages.
- Purification activities include Chromatography (Affinity, Mixed-mode, ion exchange) using the AKTA purification system, Ultrafiltration/diafiltration and viral reduction strategies.
- May train new hires and junior scientists with existing technologies.
- Work with the highest scientific standards under the direction of the Line Manager.
- Communicate project updates to internal stake holders and external customers.
- Contribute to the efficient running of the department including instigating and delivering operational efficiency projects.
- Contribute to departmental safety and training programs as required.
- Technical supervision of projects may be required.
- Degree in a relevant Science field or Equivalent.
- Minimum 3 years' industrial work experience in protein purification.
- The final role offered will be commensurate with the candidate's experience.
- Experience in Process Characterization/Process Validation for BLA studies, involving the use of statistical software for experimental design and data analysis will be highly advantageous.
- Understanding of cGMP regulations will be advantageous.
- Good technical writing skills, communication skills (verbal and written) problem solving and analytical skills and a great team player.
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Scientist 3, Purification Development, DS - 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 position will be primarily based in Science Park
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: R59805