Cello Therapeutics, Inc. is a rapidly growing biotech company located in the Sorrento Valley—one of the major biotech hubs in the nation. Cello focuses on the development of novel nanotherapeutics based on biomimetic cell membrane-coated nanoparticles for cancer treatment. Cello offers a highly motivational and rewarding working environment with attractive salary and benefits.
CMC Development Scientist
The CMC Development Scientist will work with CMC Project Leads to coordinate multiple projects and contribute to key functions, including formulation and process development, material inventory, tech transfer, development and implementation of CMC SOPs, and authoring of relevant documents required to support INDs and BLAs. The CMC Development Scientist will play a key role in the manufacturing of novel nanotherapeutics for clinical testing. A successful candidate will have excellent written and oral communication, teamwork, and organizational skills, as well as the ability to be self-motivated and work independently. Prior experience in biotech or pharmaceutical companies is a must, as well as knowledge and understanding of cGMP regulations and ICH guidelines. Experience in nanotechnology and nanoparticle testing is desired.
Senior Regulatory Consultant
The Senior Regulatory Consultant will work closely with the CMC team as well as the C-level executives to establish regulatory strategies and processes.
The Consultant will contribute to the initiation of INDs as well as communication with the FDA. He or she will support high quality submissions including INDs, NDAs, BLAs, and amendments. Responsibilities will also include consulting for the publishing and archiving of regulatory submissions. Based on prior experiences working with the FDA, the ideal candidate will communicate regulatory strategies and plans to ensure alignment with the overall project plan and business strategy. The candidate must have significant strategic experience in CMC regulatory affairs with a strong biologics background.