Senior Manager / Manager, Quality Control

Location
San Diego, CA, United States
Posted
Apr 28, 2021
Ref
490RL
Discipline
Quality, Quality Control
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Fate Therapeutics, Inc. is seeking a highly motivated Sr. Manager/Manager to support the CTO/CTL (Contract testing organization/laboratory) management for the Quality Control (QC) Department. This role will coordinate the activities with outside CTO vendors including vendor selection, contract preparation, sample management, material handling, testing results tracking, data and CoA review, and troubleshooting testing issues with CTOs. This position will also help and support vendor qualification, vendor audit, raw material handling and occasionally lab testing within a Good Manufacturing Practices (GMP) environment. The successful candidate must thrive in a fast-paced team environment, have excellent communication, planning and organizational skills, and manage assigned activities to meet Fate's priorities and timelines. This role requires extensive interaction with Research & Development, Quality Assurance, Program Management, Regulatory Affairs, Technical Operations, and Contract Testing Organizations (CTOs). This is a fulltime position reporting to the Associate Director, Quality Control and is located at our corporate headquarters in San Diego, CA.

Responsibilities
• Maintain, and continually assess the internal CTO sample submission on-line process to ensure smoothly sample handling, shipment and tracking of testing results from each department to CTO vendors.
• Lead and support cross functional teams by timely communication of testing results, review process progress and troubleshoot results related to sample submission and testing method.
• Actively involved in vendor qualification and audit process.
• Contribute to the development and continuous improvement of the sample management and raw material handling.
• Manage new method evaluation and outsourced testing activities with CTOs.
• Occasionally facilitate and perform method optimization, transfer, qualification, and validation for manufacturing in-process control (IPC), lot release, and stability testing of clinical drug product within a GMP environment.
• Write/review/approve, methods, protocols, and reports.
• Maintain current knowledge base of regulations, corporate policies, and industry best practices, trends, and standards to ensure that the function remains in compliance with applicable company requirements and global regulations.
• Assist in the implementation of new assay methodologies and the associated instrumentation.
• Onboard new materials and reagents and participate in materials risk assessment.
• Manage and train staff.
• Other duties as may be required.

Qualifications
• B.S in Analytical Chemistry, Life Science, Microbiology, Biochemistry, or related discipline with a minimum of 5 years' experience in biotechnology, clinical, or pharmaceutical QC laboratory experience is required, advanced degree is preferred.
• 2+ years' experience at managing a group with 2-3 people.
• Good organization skill and interpersonal communication skills.
• Experience working in a regulated environment (e.g., GMP, GLP, or CLIA) is highly preferred.
• Demonstrated success working with multiple contract testing labs.
• Experience running multicolor flow cytometry, ddPCR, qPCR, ELISA, and/or cell-based assays is preferred.
• Strong scientific, analytical, problem solving, and communication skills as well as sound judgment, with the ability to work both independently and effectively with others.
• Highly organized, detail-oriented with excellent record keeping abilities, and computer proficiency.
• Ability to work in a fast paced and dynamic environment that will require management of several competing priorities while driving all projects forward and meeting program/project deliverables.
• Energetic, flexible, collaborative and proactive; a leader who can positively and productively impact initiatives.

Working Conditions and Physical Requirements
• Will require working with cells and cell lines of human and/or animal origin.
• Occasional evening and weekend work will be required.
• 100% on-site work at corporate headquarters in San Diego, CA
• 10% traveling may be required after COVID situation is resolved and travel is permitted.
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 curriculum vitae to: careers@fatetherapeutics.com and reference job 490RL.

About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer. 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 pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). The Company's pipeline also includes 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 in patients with hematologic malignancies undergoing allogeneic stem cell transplant. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.