This position within the Center of Regenerative Biotherapeutic’s Process Development team will be responsible for contributing to projects focused on the translation of innovative immune effector cell therapies, including CAR-T developed at Mayo Clinic and/or in collaboration with industry partners.   Demonstrated experience with aseptic technique and cell culture required. Experience with immune cell identification, isolation and culture preferred.

Work unit process development engineer who under the guidance of the senior scientist, managers, and lead engineers contributes to the development, scale-up and optimization of novel/new biotherapeutics in preparation for cGMP compliant manufacturing operations. Optimization of process steps to target process scale for improvement of existing methods or implementation of novel technology of proven validity. Assists in drafting technical documentation such as study reports, standard operating procedures (SOPs), manufacturing batch records and associated records to support transition of biotherapeutics into clinical production and product validation for FDA-regulated, cGMP compliant manufacturing operation.

Responsibilities will include the execution of studies to support process optimization for clinical translation of novel biotherapeutics. Works with the process development engineers, scientists and project managers. Analysis, organization, and presentation of data in a clear and concise manner. Creation of batch documentation, maintenance of laboratory notebooks and preparation of protocols and reports in a compliant manner.

Assists in the development of release testing methods and the maturation of research analytical methodologies into development and cGMP processes. Facilitates analytical method technology transfer to and from our facilities and/or contract vendors. Executes laboratory studies, analyzes experimental data and carefully documents resultant information. Assists in training manufacturing personnel in final product manufacturing processes.

• Bachelor's degree in biotechnology, biological science, chemistry, immunology, cell/molecular biology, bioengineering or other related science from an accredited institution.
• 3-5 (Bachelor’s) or more years of related process development or laboratory experience within the biologics industry.
• Self-motivated, highly organized, efficient, and able to follow work orders with minimal supervision. 
• Excellent written and verbal communication skills are necessary. 
• Experienced in aseptic mammalian cell culture techniques and protocols. 
• Familiarity with various culture methods such as 3D culture systems, bioreactors and closed systems, desired. 
• Experienced in cell culture analyses such as cell viability evaluations, flow cytometry, immunocytochemistry, bright-field and confocal microscopy, spectrometry, and PCR. 
• Demonstrated analytical and scientific competency with process development and/or validation of lab techniques or procedures. 
• Assists in investigating alternative approaches for process optimization. 
• Experience with data collection, organization, analysis and delivery of information.

Visa sponsorship is not available for this position.  This position is not eligible for F-1 OPT STEM extension.