"Process Development Scientist"

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.

Document requirements

• Curriculum Vitae - CV must clearly list current and/or pending qualifications (e.g. board eligibility/certification, medical licensure, etc.).
• Cover Letter

Reference requirements

• 3 required (contact information only)