- Lead multiple projects in the area of expertise of increasing scale and complexity, including oversight of junior scientists within project team(s) for Process Development/Process Validation / Process Characterization activities, including experimental designing, planning, supervising and directing studies.
- Efficiently plans own time and prioritizes lab work for self and project teams with minimal input from supervisor to deliver project goals.
- Perform hands-on laboratory work in the purification process development team contributing or leading the development of processes suitable for technology transfer to the cGMP manufacturing teams.
- Purification activities include Chromatography (Affinity, Mixed-mode, ion exchange) using the AKTA purification system, Ultrafiltration/diafiltration and viral reduction strategies.
- Process Development including purification of monoclonal antibodies, fusion proteins, bispecifics and/or complex proteins.
- Process Characterization activities including Risk Assessment (FMEA), employing DoE methodologies, data analysis and interpretation to define process parameter ranges and process steps.
- Draft and review high quality technical documents- Protocols, reports, SOPs etc.
- Document results in accordance with Lonza policies and current Good Manufacturing Practices (cGMP) – as appropriate.
- Be the Study Director and/or project representative delivering high-quality communication to ensure an outstanding customer experience (written documents, telecons, face to face meetings).
- Work as an integral part of a site and global project team, co-ordinate multiple projects and ensure timely delivery of project work stages.
- General lab support including housekeeping, equipment maintenance, inventory of supplies, etc. while actively contributing to operational efficiency initiatives.
- Troubleshoot equipment and scientific issues.
- Train new scientists, juniors and peers with existing or new technologies as required.
- Any other duties as assigned by management.
- Degree/PhD in a relevant Science field or equivalent.
- Minimum 5 years' work experience in relevant field or PhD with 2 years postdoctoral/ 3 years of industrial experience.
- The final role offered will be commensurate with the candidate's experience.
- Expertise with relevant years of experience in protein purification process development.
- Experience in Process Characterization/Process Validation, involving the use of statistical software for experimental design and data analysis will be highly advantageous.
- Understanding of cGMP regulations will be advantageous.
- Excellent technical writing skills.
- Excellent communication skills (verbal and written).
- Good problem solving and analytical skills.
- Good team working skills.
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Senior/Lead Scientist, Development Services - 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 Purification Development team in Development Services, Lonza Singapore. As a Senior/Lead Scientist , you will be able to develop and enhance your technical and scientific capabilities as well as build on your technical leadership skills. You will be involved in hands-on experimental activities as well as leading projects right from planning to delivery. You will be the project representative, responsible for the progress of the project with co-ordination within the team as well as the cross functional team members and be the face of Lonza representing the downstream process team to interact with customers stationed across the globe.
Duties and Responsibilities include:
Education Experience
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.
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Reference: R59874