Lead Scientist, Purification Development

The successful applicant for this position will be joining the Purification Development team in Development Services, Lonza Singapore. Lead Scientist role supporting process characterisation and viral clearance teams. Develop technical skills and improve technical leadership. As a Study Director you will conduct studies showcasing purification process efficiency to support regulatory requirements. Manage project advancement, coordinate with team and cross-functional members, and represent Lonza's downstream services team in customer engagement. " Relocation support will be provided for the right candidate ".
Duties and Responsibilities include:
Lead multiple projects in the area of expertise of increasing scale and complexity, including oversight of junior scientists within project team(s) for Process Characterization and Viral Clearance activities, including experimental designing, planning, supervising and advising studies.
Efficiently plans own time and prioritizes lab work for self and project teams with minimal input from supervisor to deliver project goals.
Function as a Study Director, who has the overall responsibility of planning and conducting, as well as the interpretation, analysis, documentation and reporting of results.
Process Characterization activities including Risk Assessment (FMEA), employing DoE methodologies, data analysis and interpretation to define process parameter ranges and process steps.
Design viral clearance studies in accordance with guidelines (e.g. EMEA and ICHQ5A) and perform hands-on laboratory work (e.g. small-scale control run, virus models spiked run, virus inactivation step evaluation, virus reduction filtration) following protocols and working to GMP standards.
Purification activities include Chromatography (Affinity, Mixed-mode, ion exchange) using the AKTA purification system, Ultrafiltration/diafiltration and viral reduction strategies.
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.
Develop and manage relationships with external customers and teams at contract testing laboratories.
Deliver 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.
Education Experience
Degree/PhD in a relevant Science field or equivalent experience.
Minimum 5 years' work experience in relevant field or PhD or equivalent experience 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 purification process development, process characterisation and/or viral clearance.
Experience in Process Characterization/Process Validation, involving the use of statistical software for experimental design and data analysis will be highly helpful.
Strong understanding of
GMP regulations
and regulatory expectations for process characterisation and viral safety.
Understanding of cGMP regulations will be advantageous.
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