Process Development Engineer 3 - 128394

UCSD Layoff from Career Appointment: Apply by 03/12/2024 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.

Special Selection Applicants: Apply by 03/22/2024. Eligible Special Selection clients should contact their Disability Counselor for assistance.

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 Process Development/ R&D Engineer 3 uses professional engineering concepts to design and execute protocols that develop new or existing cell-based therapy production processes. As part of the Process Development (PD) team, this experienced engineering professional researches, evaluates and implements new methods and technologies to enhance operations. They must demonstrate good judgment in selecting methods and techniques to ensure scientifically sound approaches. They shall work alongside clients to lead technology transfer efforts for new processes and methods and work cross-functionally with Manufacturing and Quality as technical support for the new processes. Individuals must have experience supporting process development at a R&D Engineer 2 level or equivalent training.

Uses skills as a seasoned, experienced engineering professional in a specialized engineering field on a major training and / or research effort. Assignments typically require concentration in a field of application where subject matter knowledge relevant to research objectives and methodology is of great value in understanding and establishing engineering design criteria. Demonstrates good judgment in selecting methods and techniques forobtaining solutions.

• Seven years of related experience, education/training, OR an Bachelor’s degree in related area plus three years of related experience/training.

• Thorough knowledge and experience with engineering principles and methods to independently perform the full range of engineering professional design work. Familiarity and demonstrated experience 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.

• Thorough knowledge necessary to apply principles, practices and procedures in the completion of assignments. Knowledge of pluripotent cell-derived therapeutics and production technologies, of gene editing principles and cell engineering platforms.

• Ability to work in a collaborative manner; identify challenges and barriers and recommend resolutions.

• Hands on technical experience with small (pilot) scale cell therapy processes e.g. cell i solation, purification, washing, differentiation and cryopreservation and analytical methods e.g. flow cytometry.

• Effective written and verbal communication and presentation skills. Must have an acute attention to detail and the demonstrated ability to keep accurate and clear records of activities and findings.

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

• Demonstrated organizational and decision-making abilities to prioritize competing work assignments in order to meet deadlines and adherence to quality standards. Proven ability to independently manage time, set priorities and meet deadlines.

• Strong analytical and judgment skills to independently conduct analyses and develop appropriate recommendations. Knowledge of Design of Experiments (DOE) principles and experience with process optimization strategies.

• Proficient with change management e.g. performing impact assessments and change control workflows and ability to adhere to Quality standards

• 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.

Pay Transparency Act

Annual Full Pay Range: $82,500 - $151,500 (will be prorated if the appointment percentage is less than 100%)

Hourly Equivalent: $39.51 - $72.56

Factors in determining the appropriate compensation for a role include experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. The Hiring Pay Scale referenced in the job posting is the budgeted salary or hourly range that the University reasonably expects to pay for this position. The Annual Full Pay Range may be broader than what the University anticipates to pay for this position, based on internal equity, budget, and collective bargaining agreements (when applicable).

If employed by the University of California, you will be required to comply with our Policy on Vaccination Programs, which may be amended or revised from time to time. Federal, state, or local public health directives may impose additional requirements.

If applicable, life-support certifications (BLS, NRP, ACLS, etc.) must include hands-on practice and in-person skills assessment; online-only certification is not acceptable.

UC San Diego Health Sciences is comprised of our School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, The Herbert Wertheim School of Public Health and Human Longevity Science, and our Student Health and Well-Being Department. We have long been at the forefront of translational - or "bench-to-bedside" - research, transforming patient care through discovery and innovation leading to new drugs and technologies. Translational research is carried out every day in the hundreds of clinical trials of promising new therapies offered through UC San Diego Health, and in the drive of our researchers and clinician-scientists who are committed to having a significant impact on patient care. We invite you to join our team!

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