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 successful applicant for this position will be joining the Analytical Development department, consisting of 3 sub-teams (Process Analytics, Method Development and Validation and Product Characterization) within Development Services in Lonza Singapore, Science Park Facility.
At Development Services, we are responsible for the development and characterization of manufacturing processes used for the production of novel therapeutic recombinant proteins for Lonza’s global client base. The work in the Analytical Development department focused on providing rapid analytical support for upstream and downstream process development, process characterization studies and other standalone analytical stages supporting customer’s IND/BLA application. The purpose of this role is to execute analytical studies to a high standard in compliance with ICH guidelines, GMP and business principles. Customer interaction and occasional weekend work may be required for this position.
Duties and Responsibilities include:
Execution of analytical testing, analyze and interpret data to communicate progress and escalate challenges to Line Manager, project teams and customers as appropriate.
Test methods employed include, but are not limited to, techniques using capillary electrophoresis, HPLC/UPLC, spectrophotometry, ELISAs, automation including Bravo and Hamilton, LC-MS (peptide mapping, intact mass analysis and oligosaccharide profiling), SEC-MALS, etc.
Exercise technical discretion in the design, execution and interpretation of experiments for method development, method validation, reference standard creation and qualification, forced degradation, product characterization and biocompatibility studies per relevant ICH regulatory guidelines.
Review and approve GMP documentation e.g. SOPs, protocols and reports, regulatory documents as required.
Leading problem solving investigations and supports OOS/Aberrant result investigations as required.
Manage multiple studies and discuss data changes/discrepancies (through both written reports and verbal presentations) where applicable.
Deliver high quality communication to ensure an outstanding customer experience (written reports, teleconferences and face to face meetings) where applicable.
Working as part of a site and global project team, co-ordinate multiple projects and ensure timely delivery of project work stages.
Lead improvement projects and driving new innovations within the analytical function.
When needed, facilitate communication between other departments in Singapore and across the global Lonza network (e.g. Development/MSAT/QC/QA/Program Management) relevant to area of expertise.
Demonstrate flexibility to support other activities within the Analytical Development department
Become established as a Subject Matter Expert in a specific area.
General
To work to the highest scientific standards under the direction of the Line Manager.
To communicate project updates to internal and external customers.
To contribute to the efficient running of the department including instigating and delivering operational efficiency projects.
Contribute to departmental safety and training programs as required.
Well organized with good problem-solving skills, a high level of attention to detail and have a passion for delivering high quality data on time.
Execution multiple projects simultaneously, ensuring work is planned and scheduled appropriately and delivered to agreed timelines and quality standards.
Education and Experience:
Degree/PhD in a relevant Science field or Equivalent
Minimum 2 to 5 years of related work experience. Fresh graduates are welcome to apply.
Practical laboratory experience in analytical testing for antibodies or proteins is required although training will be provided.
Would suit a candidate with prior experience in a cGMP / QC laboratory.
Understanding of theory and application of mammalian cell culture for production of protein production, purification and analysis.
Have experience in automation such as Bravo and Hamilton
Demonstrated experience with methods and instruments used for protein characterization such as LC-MS (peptide mapping, intact mass analysis and oligosaccharide profiling), icIEF, CE-SDS, HPLC (SEC, RP, HIC, IEX, HILIC), SEC-MALS and AKTA including expertise in the analysis of the resultant data.
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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