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.
The candidate should possess deep scientific and technical knowledge and experience in developing, transferring, optimizing and validating assays to support pre-clinical and clinical development of Cello’s nanoparticle technology.
Responsible for development and implementation of bioanalytical assay using appropriate fit-for-purpose assay technologies to support nonclinical, clinical product development.
Work with CROs to support GLP pre-clinical studies such as PK and TK, serve as technical expert on assay trouble shooting, and assist in review of assay qualification/validation reports and sample analysis reports from CROs.
Write bioanalysis method protocols, sample analysis procedures, and reports
Responsible for data QC and bioanalytical reports.
Senior Safety Pharmacology and Toxicology Consultant
The Pharm-Tox Consultant will be a key leader of our teams and will be responsible for providing valuable input on the design, analysis, interpretation, and reporting of Safety Pharmacology and Toxicology data for Cello’s programs. The candidate will communicate directly with all departments (i.e. R&D, Product Development, CMC, Quality, etc.) at Cello Therapeutics and will liaise with Research and Development colleagues to develop overall Safety Pharmacology and Toxicology development strategies. S/he will help to guide preclinical development of Cello’s programs and regularly interface with internal and external colleagues to ensure timely and accurate conduct and dissemination of Safety Pharmacology and Toxicology studies. Primary duties include:
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.