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.

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!

Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached.

To foster the best possible working and learning environment, UC San Diego strives to cultivate a rich and diverse environment, inclusive and supportive of all students, faculty, staff and visitors. For more information, please visit UC San Diego Principles of Community.

UC San Diego is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status.

For the University of California's Affirmative Action Policy please visit: https://policy.ucop.edu/doc/4010393/PPSM-20
For the University of California's Anti-Discrimination Policy, please visit: https://policy.ucop.edu/doc/1001004/Anti-Discrimination

UC San Diego is a smoke and tobacco free environment. Please visit smokefree.ucsd.edu for more information.

UC San Diego Health maintains a marijuana and drug free environment. Employees may be subject to drug screening.

Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.

a. "Misconduct" means any violation of the policies or laws governing conduct at the applicant's previous place of employment, including, but not limited to, violations of policies or laws prohibiting sexual harassment, sexual assault, or other forms of harassment, discrimination, dishonesty, or unethical conduct, as defined by the employer. For reference, below are UC's policies addressing some forms of misconduct:

• UC Sexual Violence and Sexual Harassment Policy
• UC Anti-Discrimination Policy
• Abusive Conduct in the Workplace