Lead Scientist, Viral Clearance

Singapore, Tuas Singapore

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 Singapore? 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 Development Services group is responsible for the development and characterization manufacturing processes used for the production of novel therapeutic recombinant proteins for Lonza’s global client base.

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.

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.

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 significant difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Reference: R58976