Senior / Principal Scientist, Cell Line and Process Development

at  Phanes Therapeutics Inc

Position: Senior / Principal Scientist, Cell Line and Process Development
Function: Research and Development
Company: Phanes Therapeutics, Inc.
Location: San Diego, CA
Phanes Therapeutics is a clinical stage biotech company focused on innovative discovery research and clinical development in oncology. The company received three IND clearances from the FDA recently: PT199 for solid tumors, PT886 for pancreatic, GEJ and gastric cancers, and PT217 for small cell lung cancer (SCLC). In addition, both PT886 and PT217 have received orphan drug and Fast Track designations from the FDA. We are looking for motivated and passionate people to join us to help discover and develop new medicines and improve healthcare. We believe that innovative thinking, seamless execution, teamwork, and integrity are key values for building success. Our mission is to become a major source of innovation in the biotech and pharma industry.
At Phanes, we understand that scientific innovation is a challenging task and that is why we are looking for exceptionally talented people to join us on our mission. We are committed to fostering an innovative and fun working environment where individuals can pursue creative ideas and deliver results, because we know that our success depends on how to realize the true potential of our people.

JOB SUMMARY:

This position seeks an individual to advance our antibody therapeutics programs to the clinic. The individual will be responsible for leading our cell line and process development efforts. Candidates will have a demonstrated record of excellent competency in laboratory research, with a focus on protein-related work, cell line development, and process development, and should have a strong understanding of mammalian cell biology, biochemistry and chemical biology, and immuno-oncology. This position is located at our facility in San Diego, CA and will report to the Director of Research at Phanes Therapeutics.

KEY QUALIFICATIONS:

• PhD in biology, biochemistry, chemical biology, chemical engineering, biological engineering, or a related life sciences or engineering field with 2+ years work experience, or BS/MS degree with 7+ years work experience.
• 2+ years of relevant cell line and/or process development experience in a research and development setting (biotechnology/pharmaceutical industry is preferred).
• A strong background in protein chemistry and biochemistry is required.
• Knowledge and experience in cell line development for the production of antibodies is required.
• Experience in protein production and purification process development and scale up, and large (pilot) scale protein production, is highly preferred. A working knowledge of GMP and GLP practices is beneficial.
• Experience interacting with, managing, and transferring technologies and processes to external partners is preferred.
• Experience in IND documents preparation is preferred.
• Excellent attention to detail, ability to design and perform experiments and maintain detailed and organized documentation.
• Willingness to take on a leadership role, including managing and mentoring direct reports.

• The individual will be expected to perform a broad range of experiments to support antibody development.
• Lead our cell line development efforts for the production of antibodies, including but not limited to:a. Bispecific antibody expression plasmids design, construction, and preparation.b. CHO cell transfection with multiple plasmids, sequential and simultaneous selection, and clonal isolation by VIPS.c. Generation and screening of stable CHOZN cell lines for antibody production, focusing on the generation of clones showing a wide range of antibody and mis-assembly products expression profiles.d. Propagation, copy number and stability validation, and generation of RCBs.
• Carry out protein production and purification process development and scale up, and large (pilot) scale protein production. Key responsibilities may include:a. Shake flask and bioreactor operation.b. FPLC operation for in large volume (1L scale columns) and small volume (2-5mL scale column) contexts, including column packing, validation, and troubleshooting.c. FPLC purification method development.d. Cell culture clarification.e. Post-FPLC downstream workup of antibody compounds, including viral filtration and diafiltration/ultrafiltration.
• Perform biophysical and biochemical characterization and analysis of monoclonal and bispecific antibodies and their mis-assembly species, and antibody fragments using a wide range of techniques, and method development thereof.
• Facilitate tech and process transfers to CDMOs for large scale manufacturing.
• Prepare and review IND documents, with a focus on process development documents.