Manager, Analytical Operations

South San Francisco, CAProcess Sciences – Analytical Development /Full Time /On-sitePosition SummaryWe are seeking an innovative and highly motivated Manager in Analytical Operations who will manage a team of scientists and analysts, advancing the development of our cell therapy manufacturing platform. The primary focus of this position is to ensure the successful execution of assays and data analysis of various analytical methods to characterize cell-based therapies.This is a multidisciplinary role as this individual will interface across various departments at the company (process development, quality, software and hardware engineers, automation engineers) on a daily basis. The successful candidate will be well versed in analytical operation and automation for cell therapy approaches.The candidate should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.ResponsibilitiesLead and manage the analytical operations team, including assay scientists and analystsSchedule/Manage routine and non-routine analysis of in-process, raw materials, finished goods, or stability samplesManage the transfer and execution of methods from internal and external partnersManage training of other analysts to perform laboratory procedures and assaysEnsure analytical operation is held to GLP and safety standardsEnsure proper data capture, analysis, and reportingReview and approve assay results and technical reportsLead troubleshooting efforts for assay or operational issuesCreate, review and approve Certificate of AnalysisReview and approve data to ensure accuracy and regulatory complianceBehave as a working backup AO analyst for testing activities as neededManage and grow a phase appropriate team of Analytical Operation personnelManage equipment validation, calibration, maintenance, and troubleshootingAssist in the preparation of dossiers and data packages in support of Cellares' products for regulatory agenciesOther duties as assignedRequirementsBachelor's, Master's, or PhD in Bioengineering, Chemical Engineering, Biology, Biochemistry, or related field with 6-20 years of analytical development or operation experience in the cell and gene therapy fieldSubject-matter expert in T-cell, HSC, B, or other immune cell therapy modalityExtensive hands-on experience with the following: BD FACSCanto/FACSLyrics, Cytek Aurora/Northern Lights, BioRad CFX series and multimode microplate reader is a mustHands-on experience with high-dimensional flow cytometry, multiplexing ELISA and aseptic technique is highly preferredExcellent verbal and written communication skills; Able to interpret, summarize, and present scientific results in a clear, concise, accurate manner to both technical and non-technical audiencesKnowledge and understanding of cGMP regulations and ICH guidelines preferredSelf-awareness, integrity, authenticity, enthusiasm and a growth mindset$90,000 - $210,000 a yearCellares total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Free EV Charging, Onsite lunches, and Stock options. All displayed pay ranges are approximate, negotiable, and location dependent.This is CellaresCellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.