Research Associate II, Cell Therapy Process Development

Job Details

Responsibilities:

• Translate scientific understanding to development of cGMP cell therapy manufacturing unit operations (i.e. activation, expansion, gene editing (viral/non-viral), cryopreservation)
• Support designing and executing experimental studies for new manufacturing technologies
• Apply Quality by Design principles to improve process performance and manufacturability
• Collect, interpret, and present technical experimentation results to project teams
• Author (e.g. study protocols, technical reports, Electronic Lab Notebooks) or support authoring (e.g. sampling plans, batch records, specifications) of key documentation to enable technology transfer
• Build and maintain strong and credible interactions with internal stakeholders
• Support delivery of phase-appropriate technology transfer strategies
• Serve as a technical resource and guide for evaluation of root cause analyses and continuous improvement initiatives
• Management of sample submissions, inventories, and raw materials testing/acquisition
• Flexible support of other C> laboratory operations as needed

Qualifications:

• BS/MS Degree in science/engineering with 1-2+ years of experience in laboratory setting (preferably cell therapy development/manufacturing)
• Experience with participating in laboratory-based process development and technology transfer activities
• Strong technical writing and communication skills to support both development and tech transfer applications

 Enigma Search

 06/01/2024

 All cities,CA