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 play a key leadership role in building and managing BeiGene’s innovation center (IC) Biologics PD/CMC platform lab. The candidate will lead a multi- functional team of internal & external scientists working across multiple programs from the innovation center incubated projects or needs from external parties. The person will also represent the PD/CMC department in IC leadership team to involve in developing strategy, assessing and making go/no-go decisions, as well as serving as project leader on selected programs.
- Lead biologics process development efforts to meet IND filing and clinical production needs.
- Expand process development team by recruiting qualified talents, acquiring appropriate instruments/equipment and their procurement and qualification.
- Strengthen process development team’s capability with focus on meeting clinical manufacturing process requirement to ensure supply reliability and productivity improvement.
- Responsible for introduction and implementation of new technologies and associated instruments/equipment and methods.
- Provide technical expertise and oversight to business partners to meet business needs.
- Support regulatory submissions by authoring relevant sections of regulatory filing documents and replying to health authority inquiry.
- Support quality management through participation in product specification development and production out-of-specification investigation.
- Manage functional budget by developing team’s cost center budget and implementing throughout the year to achieve goals.
- Responsible for other projects assigned by senior management.
- Ph.D. degree in Engineering, Chemistry, Biology, Biotechnology or related field, with at least 5 years of relevant work experience in biologics process development in a bio-pharmaceutical or CDMO setting.
- Subject matter expert on biologics process development, familiar with the latest advancement in mammalian cell culture process, AKTA systems, chromatography purification process, process automation and continuous manufacturing process.
- Experience in process characterization and validation, tech transfer between sites and to external partners and/or CDMO.
- Experience with process gap analysis and robustness assessment, manufacturing process risk assessment, production site support (person-in-plant), process analytical technology, regulatory submission, QA or QC is a plus.
- Experience leading and managing teams in a matrix organization.
- Experience of hiring, managing and developing direct reports.
- Ability to manage multiple projects/ initiatives in a fast-paced environment.
- Ability to analyze complex multi-dimensional data, generate conclusions and recommend next steps.
- Ability to effectively collaborate with internal and external partners and drive towards scientific goals in a dynamic, cross-functional matrix environment.
- Strong interpersonal, and time management skills with excellent verbal and written Chinese and English communication skills.
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