BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
The successful candidate will join a biosafety team to work on viral clearance process validation as virology expert to perform viral culture, viral clearance validation for biopharma product downstream process.
- Be master with excellent skills to work with cell culture, virus culture, viral reproduction.
- Work with biologics drug development experts to set-up the viral clearance study platform to support both traditional biologics and advanced biologics products.
- Design VC study plans for projects and develop various tests (qPCR test, virus coculture test, etc.) with strong molecular biology and cellular biology skills to trouble shoot assay problems.
- Work closely with clients to give appropriate solutions for their viral clearance validation process, including but not limit to scale down model calculation, parameters confirmation and model virus selection.
- Responsible for adherence to health and safety procedures within assigned viral spiking projects and general use of the facility.
- Perform studies with GLP standard with routine housekeeping checks on a daily, weekly and monthly basis, to ensure high standards of regulatory compliance and cleanliness of the laboratory.
- Contribute to IND/BLA documents drafting with quality and speed.
- Stay current with the latest scientific and regulation developments, maintain an international perspective.
- PhD with at least ~3 years’ experience in viral related research work or downstream process development for recombinant biologics, or Master’s degree with minimum of 5 years of relevant experience.
- Excellent virology knowledge and rich molecular biology and cellular biology experience.
- Have knowledge with a variety of biopharmaceutical purification processes such as Low PH, affinity, cation and anion chromatographic separation, depth filtration, virus filtration, ultrafiltration, ultracentrifugation, and other impurity clearance steps.
- Familiar with specific or non-specific model viruses which CHO cell line may be infected.
- Familiar with GMP or GLP regulations and also has good understanding of regulatory requirement for different filing strategy (China, EU, USA).
- Excellent interpersonal, communication and presentation skills.
- Ability to manage multiple projects/ initiatives in a fast-paced environment.
- Ability to analyze complex multi-dimensional data, generate conclusions and recommend next steps with well written lab notebook record.
- Ability to effectively collaborate with internal and external partners and drive towards scientific goals in a dynamic, cross-functional matrix environment.
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