製程開發研究員

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.

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.