Manager, Microbiology & Environmental Monitoring

General Summary:

Fate Therapeutics, Inc. is seeking a highly motivated Manager to join the Environmental Monitoring and Microbiology team as part of the Quality Control (QC) organization. Environmental Monitoring and Microbiology testing is an important function in ensuring appropriate contamination controls are established and that testing is performed to assess the effectiveness of those controls. These layered controls and testing strategies allow us to ensure the contamination free manufacturing of the cell therapies at Fate. This role will ensure appropriate reaction to excursion events as well as development of meaningful corrective action. In this role, the Manager will develop metrics by which the future Microbiology and Contamination Control efforts may be measured. The successful candidate will have a good technical basis in each of the commonly used methodologies and will ensure the proper interpretation of the data from those methods. The role will also require performance and conclusions for investigations into atypical test data and perhaps contaminations. Further, the role needs to define and implement corrective or preventative actions to enhance a facility contamination control strategy. The position will be responsible for managing the results, which should be trended and investigated as necessary. The role will require good project management and team leaderships skills to ensure the requirements are fulfilled. This role requires extensive interaction with Manufacturing, Quality Assurance, Program Management, Technical Operations, and Contract Manufacturing Organizations (CMOs). This is a full-time position reporting to the Associate Director, Microbiology, Environmental Monitoring and Raw Materials, and is located at our corporate headquarters and our research facilities in San Diego, CA.

Responsibilities:

• Serves as lead for investigations, including but not limited to EM excursion, deviation, CAPA, and out-of- specification reports.
• Develops technically justified recommendations and resolutions to investigation conclusions and ensures timely completion of reports, corrective actions and associated activities.
• Reviews routine and critical operations environmental monitoring (EM) data for accuracy and initiates corrective action where required. Writes quarterly trend reports and assists with development of more mature EM trending program.
• Develops and assist in maintaining Microbiology investigation metrics.
• Trains team members on technical writing skills and utilizing document control systems.
• Writes department protocols and reports. Prepare Standard Operating Procedures (SOPs) for approval and initiate revisions to current SOPs.
• Generates and evaluate department metrics/data for adverse trends for management review.
• Attends quality control meetings and presents micro-related trends and metrics to department leaders.
• Keeps abreast of basic regulatory requirements that affect the department and suggest process and compliance changes as needed.
• Participates in internal and client audits as needed.
• Develops, implements, maintains, and continually assesses the Companys EM and Micro testing activities to ensure contaminations control policies and practices meet internal company standards and external global regulatory requirements.
• Supports strategic planning by timely communication of deliverables, constraints, risks and options, and collaborating with cross-functional business partners.
• Contributes to the development and continuous improvement of the contamination control strategy and associated testing.
• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the companys policies and practices.

Qualifications:

• BS Degree in Biology, Microbiology, Biochemistry, or related discipline, with a minimum of 5 years in biotechnology, clinical, or pharmaceutical QC laboratory experience is required; other qualifications with additional experience will also be considered.
• Minimum of two (2) year of experience with writing and performing investigations preferred.
• Experience working in a regulated environment (e.g., GMP, GLP, or CLIA) is required, with strong knowledge of FDA, ISO, EMA, GMP and ICH requirements, in particular as they apply to environmental monitoring and microbiology as it applies to biologics and cell therapies.
• Proficiency with LIMS, MODA, CPMS, and other GMP data collection software preferred.
• Proven ability to effectively develop, communicate, and gain support for execution of plans and strategies with a wide range of stakeholders.
• Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills, and excellent interpersonal, organizational, and written and oral communication skills.
• Experience working with cell culture, human blood, and blood products using sterile technique.
• 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

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.

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). Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.