Assoc Dir,Qual Cntrl/Analytics

Job Type: Officer of Administration Bargaining Unit: Regular/Temporary: Regular End Date if Temporary: Hours Per Week: 35 Standard Work Schedule: Building: Salary Range: $130,000 - $150,000 The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. Position Summary The Associate Director of Quality Control (QC) and Analytics for the CICET facilities is responsible for upholding the highest standards of quality control and will be the primary resource for analytics across CICET facilities. This role will have a large impact on ensuring robust analytical development and release testing, supporting the timely release of cost-effective, compliant, and high-quality cell therapy products. The Associate Director of QC and Analytics will work closely with the Associate Director of Quality Assurance, especially as it relates to establishing operational and bioinformatics data analyses. Responsibilities Quality Control and Compliance Establish and implement effective QC analytics to support cGMP production within a state-of-the-art multi-product cell therapy manufacturing facility. Ensure compliance with internal and external requirements for analytical functions, including training, investigations, validation, and QC testing. Perform analytical testing for manufacturing process characterization and validation. Implement and adhere to protocols, GMP, and safety regulations in the lab. Technical Leadership and Collaboration Provide technical and managerial leadership by collaborating with key organizational stakeholders and functions to conduct analytical development and release testing. Collaborate with analytical and process development teams to develop core analytical testing capabilities for cell and gene therapy products using molecular and cellular analyses. Oversee the technical transfer between laboratories, qualification/validation of assays, and QC activities for product release. Collaborate with Manufacturing Operations, QA, and Regulatory Affairs teams to ensure quality throughout the product lifecycle. Method Development and Validation Qualify and validate QC methods and set product control system specifications. Serve as a subject matter expert on the phase-appropriate validation of test methods for clinical products intended for early to late-stage clinical trials. Work with research and process development teams to transfer biological and molecular assays, monitor process and method performance, troubleshoot, and perform continuous improvement. Documentation and Audit Management Develop, author, review, and amend SOPs, specifications, regulatory filings, or other controlled documents in collaboration with QA. Lead and actively participate in all regulatory and internal audits of the facility. Manage and support internal and external regulatory audits and inspections as required. Personnel Management and Development Actively manage a group of lab personnel, overseeing their performance management, mentoring, and career development. Oversee the hiring, development, and performance management of staff within the QC and Analytics team. Strategic Planning and Stakeholder Engagement Work closely with other functional areas to develop and execute the strategic plan for CICET facilities. Establish and maintain key relationships with internal and external stakeholders. Additional Responsibilities Monitor process and method performance, troubleshoot issues, and ensure continuous improvement. Manage the GMP Quality Control lab operation, ensuring high-quality analytical support for manufacturing and compliance with protocols and regulations. Oversee the clinical product QC testing, stability testing, method qualification, QC Microbiology, and execution of cGMP lab operations in collaboration with QA and Environmental Monitoring. Minimum Qualifications Bachelor's degree in Biology, Chemistry, or a related scientific field, or equivalent in education and experience At least 4 years of relevant scientific experience in cell/gene and GMP-regulated environment Experience with cell and gene therapy products Proven track record of successful FDA or other regulatory audits Strong analytical and problem-solving skills, with a detail-oriented approach. Excellent organizational skills and ability to manage multiple priorities. Strong interpersonal and communication skills (written/ verbal) Working knowledge of computer programs, such as Microsoft Outlook, Word, Excel, PowerPoint, SharePoint, Teams, Adobe Acrobat, and Zoom Ability to set priorities and exercise sound judgment and initiative Must possess the ability to handle multiple projects simultaneously and prioritize tasks while maintaining responsibility for timely execution Strong customer service orientation and skills, with the ability to interact and collaborate positively, constructively, and effectively with multiple constituencies Preferred Qualifications Strongly prefer at least 6 years of relevant scientific experience in cell/gene and GMP-regulated environment Strongly prefer advanced degree in a relevant scientific discipline or certification in data analytics or related data analysis education, including statistics Knowledge of environmental monitoring practices and cleanroom operations Experience in analytics within a GMP-regulated environment Certification in Quality Management Systems (e.g., CQM, CQA) Familiarity with database management and machine learning Other Requirements Successful completion of applicable compliance and systems training requirements. Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents.

Created: 2024-11-09