Codiak Biosciences is pioneering the use of engineered exosomes across a wide range of therapeutic applications is seeking an experienced leader of Analytical Development at the VP level. Analytical Development has a strategic function for Codiak encompassing development and execution of advanced, high quality and novel analytical methods and technologies in support of our research, development, manufacturing, and clinical functions.
While Codiak has made tremendous progress in this area, additional analytical innovation is required to support further growth and maturation of our expanding pipeline of exosome-based therapeutics.
- Building/managing the Analytical Development team and its assay support arm. The incumbent will provide scientific vision and expertise in all relevant technical areas.
- A broad bioanalytical expertise, including characterization of traditional & complex biologics, knowledge in proteomics, lipidomics, glycomics, cell-based potency assays, nucleic acids, nanoparticles and small molecules is expected.
- A background in up/downstream processing, formulation/stability, as well as experience with assay transfer to QC and GMP production.
- Extensive experience in drug development, preparation of regulatory filings, application of ICH guidelines (especially to novel modalities), and cGxPs are all required.
This is a unique opportunity for a strong leader to contribute to early- and late-stage process and clinical development of our advanced exosome engineering platform. The incumbent will be uniquely exposed to the full range of company activities, both external and internal, and will play a key role in shaping Codiak’s scientific and business strategy.
- The candidate will have a PhD in biochemistry, biology, biochemical engineering, chemistry, or a similar discipline with 15 years of related experience.
- The successful candidate will have the ability to work well with the rapidly growing Codiak team, to build a leading bioanalytics organization, and to deliver results in a high pace environment.
- An aptitude for creative problem solving and efficient experimental design will be essential.