Senior cGMP Cell Therapy Technician

**Kelly Science and Clinical** is the world’s most recognized brand in science and clinical staffing with more than 100 locations in North America, Europe, and the Pacific Rim. Our scientists contribute to the research and development of the next generation of small molecule drugs, biologics and cellular therapies.**Overview**We are seeking a Senior Cell Therapy Scientist for one of our clients, leading academic institution in the Los Angeles area. The incumbent will manufacture cell and gene therapies and other biological products for internal/external users in their state-of-the-art current Good Manufacturing Practices (cGMP) facility. cGMP Cell Therapy Senior Technician supports daily manufacturing operations in the cGMP facility, orders, receives and maintains materials, gowning, cleaning supplies, and consumable supplies, manages manufacturing waste streams, cleans equipment, oversees documentation, and supports in other manufacturing duties as required.**Responsibilities**+ Performs all product manufacturing duties in cGMP facilities, adhering to all applicable gowning and safety requirements. Prepares and properly stores all incoming, intermediate and final products. Performs quality control for incoming, in-process and final products. Generates batch records, chain of custody forms, certificates of analysis and other records. Maintains complete documentation throughout the manufacturing process.+ Orders cGMP facility equipment and supplies. Develops an inventory system for ongoing supplies and orders. Supports senior facility staff in maintaining cGMP budgets to ensure efficient use of equipment and materials. Establishes preventative maintenance schedule routines, and designs forms for maintaining documentation of equipment maintenance.+ Acts as technical consultant to clinicians and researchers, providing technical assistance within the facility as necessary. Develops, implements and documents standard operating procedures, making updates as necessary. Instructs and oversees cGMP technicians and instructs graduate students and post-doctoral fellows in proper procedures within cGMP facilities. Serves as a resource to cGMP facility management in identifying and assessing the appropriate complement of resources and support needed to successfully implement and execute projects.+ Applies appropriate labels to incoming and outgoing products and monitors for proper labeling and handling during manufacturing. Ensures biohazard waste is handled appropriately and that medical waste stream rules and regulations are followed. Works with management to ensure facilities’ compliance with all applicable regulations.+ Plans and organizes workflows to meet established turnaround times, dispense dates and deadlines. Attends routine meetings with management team for progress reports on projects, facility needs, and discussion of any other required items. Recommends process improvements as appropriate.+ Promotes an environment that fosters inclusive relationships and creates unbiased opportunities for contributions through ideas, words, and actions that uphold their code of ethics**Qualifications**Required:+ Bachelor’s degree in a scientific discipline (e.g., pharmaceutical, biologics).+ Three years of experience in cellular or biological manufacturing with laboratory responsibilities.+ Demonstrated knowledge base with Good Manufacturing Practices (e.g., cGMPs, GLPs, GDPs).+ Extensive experience with standard operating procedures in a cGMP laboratory setting.+ Demonstrated ability to work as an individual contributor and in a dynamic team environment.+ Excellent written and oral communication skills.+ Degree directly related specialized scientific field.+ Demonstrated knowledge of all aspects of biotechnology and cell therapy.+ Demonstrated passion for solving complex scientific issues.+ Experience with Food and Drug Administration regulations and clinical trials.+ Strong communication and writing skills with demonstrated ability to work as an individual contributor and in a dynamic team environmentPreferred+ Master’s Degree and five years of experience**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.**Why Kelly** **®** **?**Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.**About Kelly** **®**At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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