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Process Development Scientist

The Department of Laboratory Medicine at the University of California, San Francisco(UCSF) is seeking a motivated Process Development Scientist to join our Investigational Cellular Therapy (ICT) group. The ICT program aims to accelerate the development and delivery of promising new cell and gene therapies targeting cancer, autoimmunity, infectious disease, and inherited hematologic and immune disorders. ICT has established collaborations with UCSF research groups and a variety of academic and industrial partners to develop new cell and gene therapy technologies, platforms, and products.
The successful candidate will lead cellular engineering activities within a highly skilled process development team and collaborate closely with partner functions such as pre-clinical research, GMP manufacturing, analytical development, quality control, quality assurance, operations/facilities, and regulatory affairs to advance pipeline programs.

Key Responsibilities:
• Design and execute complex process development efforts using genomic and epigenomic engineering tools and platforms.
• Analyze, interpret, organize, and present data to internal and external groups in clear and concise manner.
• Author and review experimental proposals, SOPs, and technical reports for scientific publications and regulatory filings.
• Ensure data integrity, maintain laboratory record and prepare protocols and reports in a GMP-compliant manner.
• Work closely with internal and external partners to support technology transfers and implementation of new process technologies.
• Collaborate with and participate in teams to facilitate IND-enabling studies.
• Participate in GMP manufacturing campaigns for in-house products.

This position will occasionally involve long hours and some weekends and holidays. Scientific independence and attention to detail are critical to success in this position. The candidate will have the opportunity to contribute to scientific publications.

Required Qualifications:
• For Associate Specialists - A Master’s degree (or equivalent degree) in Immunology, Biological Sciences, Biomedical Engineering, or related field or five to ten years of relevant experience is required.
• For Full Specialist – A PhD (or equivalent degree) in Immunology, Biological Sciences, Biomedical Engineering, or related field or ten or more years of relevant experience is required.
• Working knowledge of basic scientific principles and methods in order to independently design and perform experiments of moderate scope and complexity.
• Hands-on experience with aseptic tissue culture techniques and flow cytometry.
• Experience with genome editing techniques (e.g. CRISPR/Cas9 editing, base editing, prime editing, etc.)
• Experience working with GMP-compatible or automated cell processing platforms and equipment (e.g., electroporation systems, closed-system cell processing devices, automated cell culture or cell washing platforms).
• Organizational abilities and decision-making to prioritize work assignments.
• Effective written and verbal communication skills with internal and external collaborators.
• Ability to work in a collaborative manner, to assist in identifying any challenges or barriers.

Preferred Qualifications:
• Familiarity with Design of Experiments (DoE) approaches for process optimization.
• Experience working in regulated environments supporting IND-enabling studies, process qualification, or clinical manufacturing.
• Experience with analytical methods such as flow cytometry, ddPCR/qPCR, or next-generation sequencing for characterization of edited cells.

Applicants must apply online with a CV, cover letter, and the contact information of 3 references. Applicants’ materials must list pending qualifications. Candidates must have required qualifications by time of hire.

See Table 24B for the salary range for this position. A reasonable estimate for this position is $75,600 - $194,800.

As a University employee, you will be required to comply with all applicable University policies and/or collective bargaining agreements, as may be amended from time to time. Federal, state, or local government directives may impose additional requirements.

The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law.

UCSF is committed to welcoming and serving all people, honoring the dignity of every individual without preference or prejudice, in support of its public mission and in alignment with our PRIDE values and Principles of Community.

As a condition of employment, the finalist will be required to disclose if they are subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct.
• “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, or discrimination, as defined by the employer.
• UC Sexual Violence and Sexual Harassment Policy
• UC Anti-Discrimination Policy
• APM - 035: Affirmative Action and Nondiscrimination in Employment