Process Development Engineer 2 - 128351

UCSD Layoff from Career Appointment: Apply by 03/05/2024 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.

Special Selection Applicants: Apply by 03/15/2024. 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 R&D Engineer 2 uses professional engineering skills to help develop scalable and GMP-compliant production processes for cell-based therapies. They work as part of the Process Development (PD) team to enact technology transfer for new processes from clients or to improve existing processes, yields and operations. Their primary activities are to assess new approaches to perform cell expansion and cell reprogramming or differentiation processes, and to support process characterization, optimization and scale-up. Secondary activities include lab management, data entry, and support of other Advanced Therapy Center projects. Individuals must have experience supporting process development at a R&D Engineer 1 level or equivalent training.

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

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

• Ability to work in a collaborative manner, to assist in identifying any challenges or barriers.

• Working knowledge of engineering principles and methods in order to independently perform professional engineering design work of limited scope and complexity. 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, etc.

• Working knowledge necessary to begin independent application of principles, practices and procedures in the completion of assignments. Experience with cell processes for pluripotent cell-derived therapeutics and production technologies. Knowledge of various immunotherapeutics' production technologies.

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

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

• Organizational abilities and decision-making to prioritize work assignments.

• Experience using laboratory equipment; knowledge of safe laboratory practices. Two (2) or more years of relevant laboratory experience.

• Strong computer skills using MS Word, Excel and Visio.

• 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: $74,300 - $134,500 (will be prorated if the appointment percentage is less than 100%)

Hourly Equivalent: $35.58 - $64.42

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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