Description
Overview
The Process Development Research Associate (PDRA) will support the development and transfer of manufacturing processes for various clients and their technologies including CART, mRNA, and Lipid Nanoparticles (LNP). The PDRA will work on processes and programs of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. The PDRA will network with peers and senior internal and external personnel in their own area of expertise.
Responsibilities
· Performs all in-house and incoming CAR-T/Gene Therapy processes.
· Executes experimental procedures with general instruction from a supervising scientist.
· Designs new experiments based on data analysis from previous experiments with guidance from supervising scientists.
· Liaison between PD and manufacturing. Participate in tech transfer activities from PD to manufacturing.
· Assist in training manufacturing personnel on CAR-T and Gene Therapy processes.
· Support cross-functional projects with research, analytical and manufacturing stakeholders.
· Maintain inventory supplies, perform lab-based activities such as cell culture and cell counting, culture maintenance, sample staining and flow cytometric analysis as required.
· Maintain organized documentation of experimental procedures, utilize lab notebooks and batch records, maintain databases.
Requirements
Education: Batchlor’s Degree in Biology/Bioengineering/Biomedical Engineering/or related scientific discipline.
Qualifications and Experience:
· 2 - 5 years of experience in Biotechnology industry, research, or academics, with at least one year in process development, either biologics and/or cell therapy.
· Experience in cell culture/aseptic techniques required.
· Experience with CAR-T and/or HSC production and familiarity with CliniMACS, Fresenius Kabi, and X-Lab instrumentation a plus.
Skills and Abilities:
· This role normally receives little instruction on day-to-day work, general instructions on new assignments.
· Strong interpersonal and diplomatic skills
· Attention to detail, organizational skills, and ability to multi-task in a dynamic environment.
· Identify opportunities for process improvements and communicate appropriately.