Process Development Engineer, Manager - 130489

In 2022, businessman and philanthropist T. Denny Sanford committed $150 million to the creation of the Sanford Stem Cell Institute at UC San Diego. This gift combines current infrastructure with new Centers intended to leverage the advantages of space-based science, including expansion and, in some ways, quite literally launch stem cell research and regenerative medicine at UC San Diego into new spaces, endeavors, and training of future stem cell scientists. Sanford Stem Cell Institute provides essential physical and human resources needed to leverage stem cell research currently being conducted at UC San Diego. As part of UC San Diego, Sanford Stem Cell Institute motivates University-wide change, sustainability, and partnership, focusing on creating the structure under which various innovative regenerative medicine units and initiatives are developed. The new UC San Diego Sanford Stem Cell Institute builds upon a $100 million gift in 2013 from T. Denny Sanford that established UC San Diego as a leader in developing and delivering the therapeutic promise of human stem cells - special cells with the ability to develop into many different cell types and which, when modified and repurposed, have the potential to treat, remedy or cure a vast array of conditions and diseases. The new UC San Diego Sanford Stem Cell Institute includes six (6) stem cell Centers led by Center Directors and Co-Directors. One of these centers, the Sanford Advanced Therapy Center (ATC), provides fundamental tools and services to move basic research findings to next stages, such as early phase trials. The ATC offers expert assistance and hands-on services to investigators who require cGLP/cGMP systems and facilities. We aid in the transition from research and development to compliant and clinically-relevant manufacture of cell therapy products for IND-enabling studies or Phase I/II trials. We specifically provide assistance with cell banking, process development and scale-up, cell therapy product characterization, document writing, product stability assessment, and packaging.

The R&D Engineer 4 uses advanced engineering concepts to lead others through complex technical challenges for cell-based therapy production improvements and design. They are expected to possess a comprehensive understanding of the field and exhibit expertise in cell-based therapy technologies and scientific principles, enabling them to tackle problems that lack precedent or clear structure. Their responsibilities may extend to managing projects, formulating strategies, and overseeing the implementation of ACTL policies and processes. Operating with significant autonomy, this technical leader must also ensure that their activities align with the organizational goals and delivers solutions that meet the evolving needs of the department. The R&D Engineer 4 / PD Manager will oversee the PD Engineer 2/3. Performs other duties as assigned.

Uses advanced engineering concepts and campus objectives to lead and perform the work of an engineering team engaged in a specialized engineering field on a training and / or research program. Regularly works on highly complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercisesindependent judgment in selecting methods, techniques and evaluation criteria for obtaining results.

• Eleven years of related experience, education/training, OR an Advanced degree in related area plus five years of related experience/training

• Advanced knowledge of specialized design work as well as the overall field. Academic and/or industry background and experience in the selected area of research. Proficiency with several of the following technologies: cell processors such as CliniMACS plus or Prodigy systems, transfection/transduction technologies, and analytical methods such as ELISA, qPCR, ddPCR, flow cytometry.

• Advanced knowledge associated with the planning, development, and fabrication of engineering systems. Hands-on experience in cell therapy product engineering and production process development and analysis. Extensive knowledge of pluripotent cell-derived therapeutics and production technologies, of gene editing principles and cellengineering platforms.

• Strong creativity and problem solving abilities to apply principles, practices and procedures within discipline to complete difficult assignments.

• Strong project management skills needed to assume responsibility for accomplishment of research objectives.

• Advanced communication skills, both written and verbal, to convey complex information in a clear and concise manner.

• Ability to work in a highly collaborative manner; readily assess complex challenges and barriers and recommend effective resolutions.

• Strong understanding of GLP and GMP standards and U.S. Food and Drug Administration guidelines and regulations.

• Must have experience supporting process development as a seasoned, experienced R&D Engineer.

• Doctorate in related area and/or equivalent experience training preferred.

• Industry experience of production process development preferred.

• Demonstrated ability to lead, motivate and influence others.

• Advanced interpersonal and presentation skills.

• Willingness to work in BioSafety Level II environment where biological (including infectious agents and blood borne pathogens) hazards are present.

• Willingness to work with human pluripotent stem cells and viruses that are infectious to humans, including adeno-associated viruses, sendai viruses, and lentiviral vectors which are derived from human immunodeficiency virus (HIV).

• Must be able to work various hours and locations based on business needs.

• Employment is subject to a criminal background check.