Fate Therapeutics, Inc. is seeking a highly motivated Director or Associate Director of Quality Control (QC) with ddPCR, flow cytometry, and cell-based assay experience to support its cellular therapy programs. This role will be responsible for providing oversight and support for execution, optimization, transfer, qualification, and validation of analytical methods supporting manufacturing in-process control (IPC) and lot release of product, within a Good Manufacturing Practices (GMP) environment. The successful candidate will have experience participating in and leading high-performing teams executing analytical test methods in a QC operations environment, working with mammalian cell culture, analyzing emerging data to assess the characteristics of iPSC-derived T cell and NK cell-based therapeutics, and GMP method qualification and validation. This role requires extensive interaction with Analytical Development, Quality Assurance, Program Management, Regulatory Affairs, Technical Operations, and Contract Manufacturing Organizations (CMOs). This is a full-time, exempt position located at our corporate headquarters in San Diego, CA
Responsibilities
- Perform GMP IPC, lot release, and stability testing using ddPCR, flow cytometry, and/or cell-based methods.
- 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.
- Describe results in detailed and organized presentations and reports.
- Participate in cross-functional training, as well as identifying and facilitating continuous method and process improvements.
- Develop, implement, maintain, and continually assess the Company’s QC function and Quality Management System (QMS) for applicable regulated activities to meet internal company standards and external global regulatory requirements.
- Lead and support strategic planning by timely communication of QC deliverables, constraints, risks and options, and collaborating with Analytical Development, Quality Assurance, Program Management, Regulatory Affairs, Technical Operations, and CMOs.
- Oversee product stability study design, monitoring, reporting, and data trend-analysis, as well as support product release, within a GMP environment.
- Oversee QC elements of raw materials qualification program.
- Establish robust analytical development strategies, inclusive of method qualification and validation, to ensure product quality and meet regulatory requirements.
- Generate stability specifications for raw materials and products, and support generation of release specifications and Certificates of Analysis.
- Manage method transfer and outsourced testing activities with Contract Manufacturing Organizations (CMO).
- Write, review, and/or approve, methods, protocols, and validation reports.
- Write, review and/or approve deviations, investigations, and CAPAs both within the Company and with CMOs.
- Establish, administer, and maintain policies, standard operating procedures (SOPs), work instructions, and forms relating to the QC function and the QMS.
- Author and review CMC analytical sections for regulatory submissions and annual reports.
- Perform periodic internal QC system reviews and audits, as well as participate in preparing for and representing QC in regulatory inspections.
- Implement, perform and oversee internal quality auditing of QC function (including applicable vendors or subcontractors), customer quality audit response, and other QC related quality management system activities.
- Maintain current knowledge base of regulations, corporate policies, and industry best practices, trends, and standards to ensure that the QC function and the QMS remain in compliance with applicable company requirements and global regulations.
Qualifications
- Bachelor's degree in Biology or related discipline, with a minimum of 8 years in biotechnology, clinical, or pharmaceutical QC laboratory experience is required; advanced degree is 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 applicable to biologics and cell therapies.
- 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.
- Leadership and management skills to grow and manage a high performing team.
- Experience running multicolor flow cytometry, with working knowledge of flow cytometers and FlowJo.
- Experience running ddPCR, ELISA, and cell-based assays.
- Experience working with cell culture, human blood, and blood products using sterile technique.
- Demonstrated skills in project management and working with vendors and contractors.
- Experience with regulatory submissions, ideally for products which were ultimately approved for commercial distribution, and regulatory inspections.
- 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 & physical requirements
- Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.
- Will require working with cells and cell lines of human and/or animal origin.
- Will require working with hazardous materials.
- May require work in controlled and cGMP Manufacturing environments requiring special gowning.
Compensation
- The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location.
- Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.
- The anticipated salary range for this role is $165,000 to $215,000 per year.
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.
Equal Employment Opportunity
Fate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.
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About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s effector cell pipeline includes multiplexed-engineered, iPSC-derived natural killer (NK) cell and T-cell product candidates, which incorporate novel synthetic controls of cell function, such as chimeric antigen receptors (CARs) to target tumor-associated antigens and are intended to deliver multiple mechanisms of therapeutic importance to patients including in combination with well-established cancer therapies. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.
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