Systems Administrator, Laboratory Information Management Systems

Location
San Diego, CA, United States
Posted
Oct 30, 2020
Ref
424SM
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Fate Therapeutics is currently seeking a talented and highly motivated systems administrator to support R&D, translational research, manufacturing, in vivo pharmacology, cell banking, and quality control systems. Successful candidates will have a background in translating business needs into technical requirements within software applications. The candidate will capture, analyze, coorelate, and configure application master data to ensure optimal performance for inventory management and laboratory information management system (LIMS) systems. The candidate must have strong expertise in the deployment of LIMS and other software services and processes through analysis of the user requirements, objectives of the Company, regulatory requirements, and best in class LIMS practices. The successful candidate will manage configuration requests across multiple projects, ensure data integrity, and convey quality devlierables on time. The position will require strong independent and collaborative technical abilities, and excellent verbal and written communication skills. This is a full-time position reporting to the Director, Information Technology and is located at the Company's corporate headquarters in San Diego, California.

Responsibilities
• Configure applications to meet end-user needs. Work in conjunction with end-usersto identify and determine operational objectives / system functionality. Gatherspecifications, and configure the application to implement specifications to meetbusiness needs.
• Translate customer business needs into software requirements effectivelycommunicating requirements to software engineers and developers.
• Ensure end user acceptance testing of deliverables meets validation system
requirements.
• Through effective verbal and written communication skills escalate issues forresolution arising outside guidelines or operating procedures.
• Maintain laboratory applications to keep current with departmental requirementsand change requests.
• Effectively operate within set FDA guidelines including 21CFRPart11, GxP policies,and other regulatory procedures, including CLIA standards for conducting clinicaltrials.
• Recommend and maintain system controls and protocols. Research and resolveend-user issues. Develop and maintain procedures and documentation as needed.
• Handle confidential material and adhere to data security and confidentiality
requirements.
• Participate in training of end-users and troubleshoot any related issues.
• Write technical and validation documents like URS, IQs, OQs, and SOPs.
• Participate in producing technical reports as requested.
• Collect, analyze and summarize information and trends.
• Participate in testing and execution of IQ/OQ and PQ functionality.
• Provide assistance in the development and maintenance of SOPs and Process Guides
related to application management activities.
• Assist with preparation of data sets and data integration.

Qualifications
• Bachelors degree in biological sciences or related scientific discipline with a minimum of 5 years experience, preferably with clinical trial related data management and lab-related software systems, including LIMS, data anaylsis and
reporting.
• Demonstrated knowledge and understanding of laboratory functions and processes.
• Experience and understanding of techniques directly applicable to research being conducted at Fate is highly desirable.
• Extensive experience with software maintenance and documentation, requirements
analysis and data anaylsis.
• Excellent creativity, technical decision-making, and trouble shooting skills.
• Excellent written and verbal communication skills.
• Demonstrated success working independently and in a cross-functional team
environment.

Working Conditions and Physical Requirements
• 100% on-site work at corporate headquarters in San Diego, CA
• Occasional evening and weekend work will be required The preceding job description indicates the general nature and level of work performed by
employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time. For consideration send cover letter and resume to: careers@fatetherapeutics.com and reference job code 424SM.

About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company's immuno-oncology product candidates include natural killer (NK) cell and T-cell cancer immunotherapies, which are
designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens with chimeric antigen receptors (CARs). The Company's immuno-regulatory product candidates include ProTmune™, a pharmacologically modulated, donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloid-derived suppressor cell immunotherapy for promoting immune tolerance in

patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.