Casebia Therapeutics is seeking a Senior Development Scientist with a passion for delivering life-changing breakthrough therapeutics to patients. The candidate will play an integral role in the Formulation Technology Development team leading the process development and manufacture of Casebia s novel gene editing therapies. The ideal candidate will have significant experience with drug product formulation and nanoparticle-based delivery technologies, and a desire to grow his/her career along with Casebia s pipeline as an integral member of the Formulation Technology Development team. The candidate will scientifically lead internal/external development activities and actively participate in technology in-licensing as well transfer to external CMOs for GMP manufacture. He/she will initially serve as an individual contributor with opportunity to oversee direct reports as the team and organization grows.
Contribute to establishing a science-based understanding of a complex drug product/process as a basis for improvement, control, and scale-up through creatively planned and carefully executed developmental experiments.
Design and execute experiments to develop nanoparticulate formulations including formulation definition, process robustness, scale-up, and stability testing.
Participate in selection and coordination of contract manufacturing organizations (CMOs) for GMP clinical material supply.
Define technical requirements of the process unit operations for implementation at CMO, including equipment specification/selection, draft procedures and recommended operating parameters/ranges, and raw materials definition and preparation.
Manufacture critical materials for developmental and preclinical testing and participate/present to cross-functional teams.
Write protocols and technical reports to support drug product clinical development.
Opportunity to also participate in drug substance process development, tech transfer, and manufacture.
Organize workstreams and complete individual and team objectives to maintain project timelines.
Participate in new technology evaluation for nanoparticle delivery, formulation, manufacture, and characterization.
Ph.D. or equivalent in biological sciences, chemistry, or biomedical/chemical engineering, with 5+ years of relevant industry experience.
Extensive knowledge of formulation and drug product development.
Proven ability to plan and execute experiments, and analyze data independently.
Experience optimizing formulation process unit operations, for example, high shear mixing, microfluidics, tangential flow filtration, chromatography, freeze/thaw, and cryopreservation.
Knowledge of practices and equipment to run formulation processes in a GMP manufacturing environment, including sterile filtration, single-use technology, and sterile/aseptic processing.
Knowledge of formulation and characterization of nucleic acid delivery technologies.
Attention to detail, critical analysis of data and troubleshooting abilities.
Experience contributing to cross-functional teams and directing the work of lab-based staff.