Sr./ Research Investigator, Analytical Development
BeOne Medicines · Taipei Neihu
About us
BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn and X (formerly known as Twitter).
BeOne 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.
Job Description:
BeOne 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 Cell Therapy Team of BeOne is seeking highly motivated individuals to join and lead analytical assay development of cell products. A successful candidate for this position will be expected to have a solid background and hands-on experience in developing various bioassays to support release and characterization of cell therapy products. Also, a depth technical knowledge and experience in method qualification, validation, and transfer to internal or external partners is required.
ROLE OVERVIEW
The role will develop, transfer, and implement analytical methods, to understand and identify the general function, activity, characteristics, purity, stability, and safety of cell products. The role will work with process development and functional assessment team, and also participate in the decision of key quality attributes of cell products and identify the analytics in release certificate and product characteristics package in IND package. The role will develop, qualify and execute analytical methods for product release performed in QC laboratory. Also, he/she will utilize their technical expertise to ensure data is accurate and high quality under the GMP guiding principle. This position will work directly with key stakeholders to gather requirements, provide ongoing reports, and build relationships.
RESPONSIBILITYIES
- Develop accurate, precise and robust functional (e.g. flow cytometry, ELISA, Western) and molecular (e.g. ddPCR, RT-qPCR) analytical methods for in process control and final product release.
- Design, test, and implement fit-for-purpose analytical assays to support the product quality and impurity characterization in cell therapy product development.
- Perform and coordinate testing to support research development, process development, product stability, and method troubleshooting across functional groups.
- Execute analytical method qualification and technology transfer to QC and partners.
- Providing technical support to QC laboratories by performing QC testing as required and assisting in investigations.
- Deliver development/technical reports, SOPs and test procedures.
- Review and discuss analytical results and conclusions both orally and in writing.
- Work in a team-based structure and interface with research and process development departments.
- Maintain the analytical equipment master schedule for qualification/ requalification/ calibration and monitor the progress within AD and QC laboratories.
- Maintain and ensure safe laboratory environment and work practices.
- Ensure timely completion of testing and tasks as assigned.
Qualification Required:
QUALIFICATIONS AND REQUIREMENTS
- PhD with 3+ or 5+ yrs. experience in industry with a focus on bio-assay development, qualification cell and gene therapy products.
- Extensive hands-on cell-based assay development experience.
- Hands-on operation and data analysis experience with immune cell-based assay and flow cytometry (FACS) is required.
- High level of proficiency in molecular biology (e.g. PCR, qPCR, ddPCR, RT-qPCR) is preferred.
- Understanding of GMP concepts, ICH guidelines, method qualification and validation preferred.
- IND experience, especially in cell therapy products, is preferred.
- Strong desire to learn and troubleshoot technical challenges.
- Collaborative mindset with strong communication skills, and the ability to effectively present data, write reports and document test procedures.
- Excellent presentation skills, written and verbal.
- Demonstrated ability to work in a highly collaborative team environment, coordinate tasks across multiple projects to meet deadlines.
- Occasional weekend work may be required.
What We Offer To Our Valued Employees
Market competitive compensation package including performance-based annual bonus scheme
Company shares (generous welcome grant!)
In-house and external learning and development opportunities
Fantastic benefits program and keep improving!
Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.
Join us and Make momentum in your career!
BeOne Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
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