- Develop, implement, and maintain laboratory systems in compliance with applicable GMP practices and regulations.
- Draft, review, and approve SOPs, test methods, specifications, and associated protocols and reports.
- Co-Qualify/Validate or Transfer test methods with Analytical Development Tech Transfer team.
- Oversee daily laboratory operations, including equipment maintenance and calibration, routine analytical testing, and results reporting in LIMS.
- Collaborate with other QC functions (i.e. QC Microbiology, QC Raw Materials and QC Outsourcing/Logistics) to ensure all testing is initiated and completed within established timelines.
- Review and approve analytical testing excursions, including deviations, CAPAs, and OOSs.
- Develop metrics to evaluate and monitor the performance of the QC cellular analytics laboratory.
- Support inspections and facility audits.
- Hire, train, and mentor laboratory staff.
- B.S. or M.S. in a technical discipline (Biology/Molecular Biology/Chemistry or related field) with a minimum of 10 years of experience in GMP QC laboratory setting, preferably in a cell and gene therapy manufacturing environment.
- Significant experience with cell and gene therapy test methodologies (qPCR/ddPCR, Flow Cytometry, ELISA, and cell-based assays).
- Ability to communicate and work independently with scientific/technical personnel.
- Strong knowledge of GMPs, SOPs, and Quality system processes.
- Excellent organizational skills.
- Experience performing laboratory investigations.
- Experience working with electronic systems (LIMS, CMMS, QMS, ERP) is a plus.
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Associate Director, QC Analytics, Cell Therapy - Waltham, United States - ElevateBio
Description
ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.The Role:
The Associate Director of Quality Control is responsible for overseeing the QC Cellular Therapy analytical laboratory, testing, and staff at our BaseCamp facility in Waltham. This position will work with Quality management and Analytical Development to implement the laboratory systems and testing strategies for ElevateBio's cell and gene therapy programs. Additionally, the Associate Director will monitor laboratory metrics and review and approve excursions associated with routine laboratory operations.
Here's What You'll Do:
ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The Company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities. The ElevateBio ecosystem combines multiple R&D technology platforms - including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform - with BaseCamp, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.
We aim to be the dominant engine inside the world's greatest scientific advancements harnessing human cells and genes to alter disease.
Our Mission:
To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.
Our Vision:
We seek to be the world's most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created and how disease is treated.
ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
