Position: Senior/Principal Scientist – Analytical Science
Function: Process Development
Company: Phanes Therapeutics, Inc.
Location: San Diego, CA
Phanes Therapeutics is an emerging leader in innovative drug discovery in immuno-oncology and eye disease. The company is built for scientific innovation and we welcome people with motivation and passion to join us to 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 for the biotech and pharma industry.
At Phanes, we understand that scientific innovation is a challenging task and that’s why we need the most talented people to accomplish our mission. We are committed to fostering an innovative and fun working environment where scientists can pursue creative ideas and deliver results, because we know that our success depends on how to realize the true potential of our people. We offer competitive compensation and excellent healthcare benefits.
This position is in the Process Development function and will work in our process development site in San Diego, CA. This lead position will focus on analytical testing and developing robust analytical methods to support process development of monoclonal and bispecific antibodies, as well as method transfer to CDMOs for clinical material manufacturing.
- Perform analytical activities in PD to support cell line, upstream and downstream process development. Working closely with other PD groups to ensure timely delivery of high-quality analytical methods and results.
- Responsible for identifying and developing analytical methods to support PD activities.
- Manage and perform in-process and release assays to deliver results on time.
- Lead and drive activities of stability studies of in-house tox and/or other batches, including protocol and report writing, execution of protocols.
- Responsible for analytical method transfer to CDMOs.
- Support in-house formulation studies and meet overall project timeline.
- Author analytical method SOPs, protocols, and development reports. Write CMC analytical sections for regulatory submissions, including INDs and BLAs.
- Keep up with new analytical technology and introduce to and establish them in the company if applicable/necessary.
- Train and supervise assistant and associate scientists to perform assigned project tasks.
- PhD with 2+ years or Master’s degree with 5+ years in analytical development/QC in the biotech/pharma industry.
- Hands-on experience with analytical methods for large molecules, including but not limited to HPLC (SEC, HIC, and RP), CE-SDS, cIEF, ELISA based assays. Experience with qPCR for residual DNA is a plus.
- Capable of developing new analytical methods, improving and troubleshooting existing methods.
- Experience in managing and executing stability/formulation studies for large molecules.
- Understand analytical requirements for regulatory submissions of IND/BLA.
- Capable of handling multiple projects simultaneously and making quick decisions for execution.
- Good oral and written communication skills are required.