Sr./ Research Investigator, Process Development

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. A successful candidate will be expected to have a solid background in cell biology, immunology, immune cell differentiation and expansion processes, scale-up, experience working in or supporting a cGMP-regulated environment, as well as sound technical knowledge of manufacturing processes for engineered immune cell therapies. You will have high internal visibility focusing on developing robust and scalable manufacturing platforms for allogeneic cell expansion and directed differentiation. You will have the opportunity to establish manufacturing platforms and guide product development through all stages of development to ensure project advancement. This role will work with analytical development and R&D team to understand and identify the general function, activity, characteristics, purity, stability, and safety of cell products. The role will identify the manufacturing flow and key process parameters and execute clinical manufacturing activities to provide the required information in IND package. 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 1. Independently design and execute phase-appropriate process development studies identifying process parameters and appropriate ranges to be assessed for optimal experimental design of the study. 2. Independently design and execute DP process-enabling studies including formulation, fill/finish, cryopreservation, thawing, and in-use compatibility study of candidate cell therapy product. 3. Apply characterization methods for process development, establish process parameters, and contribute to CMC sections of regulatory filings. 4. Testing new manufacturing technologies and platforms in partnership with R&D. Develop robust, scalable, directed-differentiation processes platform. 5. Be responsible for preparation of protocols, reports, test methods, and SOPs. 6. Review and discuss process and analytical results and conclusions both orally and in writing. 7. Work in a team-based structure and interface with research and analytical development departments. 8. Maintain and ensure safe laboratory environment and work practices. Ensure timely completion of testing and tasks as assigned. Qualification Required: QUALIFICATIONS AND REQUIREMENTS 1. PhD with 3+ or 5+ yrs. relevant experience in industry with a focus on in immune cell culture, differentiation, expansion, formulation process. 2. Knowledge of biology/immunology/biochemistry as applied in cell and gene therapy processes is required. 3. Hands-on experience with common cell therapy laboratory equipment and technology platforms (i.e. primary NK cells, iPSC-derived cell types, etc.) 4. Experience with cell culture bioreactor operations and process scale up with application to cell therapy is required. 5. Deep understanding of biologics industry process development strategies and best practices as applied from early development. 6. Familiarity with flow cytometry assays and other cell-based characterization assays (i.e. cytokine release and cytolytic assays) is a plus. 7. Demonstrated ability to work in a dynamic environment as a team player with a strong work ethic. 8. Excellent presentation skills, written and verbal. 9. Occasional weekend work may be required. Understanding of GMP regulations is preferred. 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 BeOne is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations. Due to BeOne’s global operation, job applicants’ data will be stored overseas with adequate protection. Besides, job applicants’ data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeOne. For further details, please refer to BeOne’s Job Applicant Privacy Policy ( https://beonemedicines.com/privacy-policy ). If you voluntarily provide your personal information to us, it is deemed a