Our Manufacturing Team Lead, Liso-cel CAR-T, Manufacturing manufactures human blood derived components per Batch Record and Standard Operating Procedures in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable. Shift Available: - Wednesday - Saturday (with e/o Wednesday off), Onsite Night Shift, 5 p.m. - 5:30 a.m. Responsibilities: - Oversee set-up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation. - Lead deviation investigations and write ups as needed. - Accountable for on time closure of any assigned CAPAs within the designated shift. - Aseptic technique is required for tube most activities: welding, connections, and transfers, at minimum. - Aseptic qualification is required. - Weighs and measures in-process materials to ensure proper quantities are added/removed. - Adheres to the production schedule ensuring on-time, internal production logistics. - Records production data and information in a clear, concise, format according to proper GDPs. - Perform all tasks in a manner consistent with site safety policies, quality systems, and GMP requirements. - Works in a team based, cross-functional environment to complete production tasks required by shift schedule. - Motivated, team consciousness individuals are needed to fulfill job requirements. - Is a SME and qualified trainer within a designated function of manufacturing. - Team Lead is responsible for the designated area within the shift. - Shift supervision will be managed by the shift Supervisor, but Team Lead will act as Supervisor when needed - Maintain on time completion of training assignments and those of the associates in the designated area to ensure the necessary technical skills and process knowledge required to execute operations in a GMP compliant manner. - Performs other tasks as assigned: Lead continuous improvement projects, inspection readiness, right first-time initiatives, etc. Knowledge & Skills: - Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique. - Knowledge of cGMP/FDA regulated industry. - Basic mathematical skills. - General understanding of cGMPs. - Technical writing capability. - Proficient in MS Office applications. - Background to include an understanding of biology, chemistry, medical or clinical practices. Minimum Requirements: - Pre-requisites: Must be a Senior Associate in Cell Therapy Manufacturing. - Bachelor's degree and 2-4 years of experience in cell therapy of Biopharmaceutical operations. - Associate / Medical Technical degree and 6+ years of Manufacturing Operations experience. - High School diploma/GED and 8+ years of Manufacturing or Operations experience. Working Conditions: - Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary. - Must be comfortable working with contained human blood components. - Physical dexterity sufficient to use computers and documentation. - Sufficient vision and hearing capability to work in job environment. - Ability to lift 25 pounds. - Must have the ability to work around laboratories and controlled, enclosed, restricted areas. - Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet. - Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas. - Flexibility to don clean room garments and personal protective equipment (PPE). - Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions - Reagents, chemicals, and exposure to sanitization agents are expected. - Designated areas may prohibit food, any outside materials such as cell phones, tablets, at a minimum. - This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. - The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. - This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. - There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. - Employees holding this position will be required to perform any other job-related duties as requested by management. BMSCART, #LI-Onsite We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway. Compensation Overview: Summit West - NJ - US: $38.12 - $46.20per hour The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully - carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance. Benefits: Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans - including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability). U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year. Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays. Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day. U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits How We Work Where you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working. R1606878 : Manufacturing Team Lead, Liso-cel CAR-T, Manufacturing Operations