Sr./ Research Investigator, Analytical Development at BeOne Medicines in Taipei Neihu

Job description

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