You haven't searched anything yet.
We are seeking a Head of Process Engineering to join the Manufacturing, Science and Technology (MSAT) team and support ongoing process development, manufacturing of GMP grade material for company's Phase 1 and 2 clinical trials, technical transfer from preclinical to clinical Phase 2, IND authoring and agency interaction activities. In particular, this role will focus on optimizing the GMP manufacturing platform for company's all clinical assets. The candidate will work with Chief Technology Officer to lead authoring the CMC chapters of regulatory submitted documents, ensuring all required data integrity and technical compliance standards are met. This role will also contribute strategically and technically to future lifecycle considerations e.g. productivity improvements, scale-up vs. scale-out decisions etc.
The candidate must have a proven track record in supporting the development, scale-up, registration and manufacture of cell therapy processes. The candidate must also excel in communication and collaboration, as this role requires many interfaces both internal and external to Cartesian. The successful candidate will also be comfortable with change, being flexible to deal with shifting landscapes and new challenges.
Principal Duties/Responsibilities:The position requires hands-on work setting up and operating equipment in R&D and manufacturing environments. An employee in this position works in an environment in which safety, environmental and health concerns may demand constant attention. Strict adherence to Cartesian's policies, rules and regulations is required. While performing the duties of this job, the employee handles hazardous chemicals in the laboratory. The employee will be required to wear all appropriate safety equipment including but not limited to eye protection, gloves, shoes, and lab coat. Position may require extended periods of standing.
Full Time
$140k-182k (estimate)
05/04/2024
05/19/2024
cartesiantherapeutics.com
Gaithersburg, MD
<25