
Scientist in Process Development
2 days ago
This role is a great opportunity to join our team in Purification Development. As a Lead Scientist, you will be responsible for supporting process characterisation and viral clearance teams. You will develop technical skills and improve technical leadership by conducting studies that showcase purification process efficiency to support regulatory requirements.
Duties and Responsibilities:
1. Plan, oversee, and advise on experimental designing, planning, supervising, and conducting studies.
2. Prioritize lab work efficiently, with minimal input from supervisor, to deliver project goals.
3. Function as a Study Director, responsible for overall responsibility of planning and conducting, as well as interpretation, analysis, documentation, and reporting of results.
4. Conduct risk assessments (FMEA) employing DoE methodologies, data analysis, and interpretation to define process parameter ranges and process steps.
5. Design viral clearance studies in accordance with guidelines and perform hands-on laboratory work following protocols and working to GMP standards.6. Perform purification activities including Chromatography using the AKTA purification system, Ultrafiltration/diafiltration, and viral reduction strategies.
7. Draft and review high-quality technical documents such as Protocols, reports, SOPs etc.
8. Document results in accordance with Lonza policies and current Good Manufacturing Practices (cGMP) – as appropriate.
9. Develop and manage relationships with external customers and teams at contract testing laboratories.
10. Deliver high-quality communication to ensure an outstanding customer experience.
11. Work as an integral part of a site and global project team, coordinating multiple projects, and ensuring timely delivery of project work stages.12. Provide general lab support, contributing to operational efficiency initiatives, troubleshooting equipment and scientific issues, training new scientists, juniors, and peers with existing or new technologies as required.
Required Skills and Qualifications:
* Degree/PhD in a relevant Science field or equivalent experience.
* Minimum 5 years' work experience in a relevant field or PhD or equivalent experience with 2 years postdoctoral/ 3 years of industrial experience.
13. Expertise with relevant years of experience in purification process development, process characterisation, and/or viral clearance.14. Strong understanding of GMP regulations and regulatory expectations for process characterisation and viral safety.
Benefits:
Relocation support will be provided for the right candidate.
Others:
Any other duties as assigned by management.
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