Manager, CAR T Manufacturing Records and Procedures

Working with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.The manager is responsible for scheduling and monitoring on time completion of training of staff, tracking performance of staff against goals and objectives, and tracking on time action completion. The manager will collaborate with internal Manufacturing partners, such as but not limited to Manufacturing Science and Technology (MSAT), Warehouse, Environmental Health and Safety (EHS) and Quality groups to support the completion of improvement actions (Deviations, CAPAs, Change Control and Document updates). Deviation ownership support will be provided as needed to meet business demand. The manager will also be responsible for scheduling, monitoring, and ensuring on time completion of CAPAs, CAs, document updates, periodic reviews, proactive initiates, effectiveness checks, and audit findings for direct reports and MO organization. Will attend CAPA focused sessions, such as IRB, CRB, and CCRB and provide feedback to stakeholders. The manager will ensure the resources are adequate to meet the business needs and escalate any compliance issues immediately to the leadership team.Shift available:Monday - Friday, Onsite Day Shift, 8:00 a.m. - 4:30 p.m.Responsibilities:DeviationsAttend alignment meetings.Ability to create and/or review already created QMS deviations, provide feedback when needed, and ensure timelines are met.Complete investigations for deviations.Ability to perform a review of drafts completed by the technical writers and provide feedback, coaching, and mentoring.Facilitate process and site knowledge to MO organization and coordinate ongoing change efforts.Ability to track and trend deviations (closure time and pattern/re-occurring events).CAPAsSchedule and monitor CAPAs to ensure on time closure/implementation.Able to collaborate with cross functional departments to build and leverage ideas, data, and insights for CAPAs, effectiveness checks and document updates.Responsible for opening CAPAs as needed.Ability to complete CAPA Actions within QMS.Ability to challenge and/or justify CAPA Actions.Ability to identify compliance gaps and work cross functionally with stake holders to make necessary updates to documents.Ensure on-time closure of CAPAs and Effectiveness Checks for the MO organization.Change ControlsResponsible for on-time closure of Change Controls Actions for the MO organization.Able to collaborate with cross functional departments to build and leverage ideas, data, and insights for parent change controls, change control actions, impact assessments and effectiveness checks.Responsible for opening Parent Change Controls and Change Control Actions as needed to revise documents to support new product/process implementation.Ability to work cross-functionally to make necessary updates to procedures to address procedural gaps and/or new processes implementation.Attend Alignment Meetings.Ability to challenge and/or justify Change Controls.Facilitate pre-CCRB meetings and attend CCRB.Continuous ImprovementAbility to lead and participate in continuous improvement initiatives.Help lead reduction of human error deviations by data tracking and continuous improvement.Actively participates and leads team in improving processes.Able to be a critical thinker to develop and optimize work processes finding ways to simplify and standardize.Knowledge & Skills:Understanding of cell culture, cryopreservation, and aseptic processing for cell therapy drug products.Knowledge of cGMP and FDA regulated industry.GMP, Quality, and in-depth risk management knowledge.Basic mathematical skills.Strong technical and compliance writing capability.Proficient in MS Office applications.Background to include an understanding of biology, chemistry, medical or clinical practices.Previous experience leading and closing deviation investigations.Working experience in the CAPA process and ability to identify and verify effectiveness.Advanced working experience of deviation investigations, utilizing root cause analysis tools.Proven ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements.Experience supporting health authority inspections.Knowledge of data trending and tracking, including use of statistical analysis software a plus.Demonstrate advanced problem-solving ability/mentality, technical adeptness and logical thinking.Ability to set priorities, manage timelines and effectively react/manage changing priorities.Ability to work with management (global and site) and support corporate and department goals.Ability to communicate honestly, transparently, and effectively with peers, department management and cross functional peers.Hands on experience preferred with CAR T or biopharmaceutical manufacturing.Ability to train and mentor junior associates to foster and develop their expertise.Ability to hire and recruit candidates.Knowledge of performance management (i.e performance reviews).Prior people management experience preferred.Critical thinking skills necessary to resolve conflicts effectively.Minimum Requirements:Bachelor’s degree and 5 years of Manufacturing or Operations experience in a regulated environment.OR Associate/ Medical Technical degree and 8 years of Manufacturing or Operations experience in a regulated environment.High School Diploma/GED and 10 years of Manufacturing or Operations experience in a regulated environment.A minimum of 2 years of leadership (people management) experience or mentorship of junior associates is required.Working Conditions:On site presence is based on business need and will be communicated by management. In our shared office space, designated seating arrangements are available for all Specialists. There will be sufficient lighting and temperature control regardless of season or time of day. Noise ideally is kept to a minimum in this shared environment to maximize your efficiency and communication skills. Heavy lifting and other strenuous activities are unnecessary and should not be performed unless otherwise stated by your manager. Sitting for long periods of time is required for this position, however, at times employees may be obligated to walk to other departments for several reasons. It is recommended, but not required, to get up every hour or so for a short walk as defined in ergonomics training. 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.Although position is primarily office based, some on floor/clean room interactions may be required. Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals and exposure to sanitization agents could be expected. Potential exposure to human blood components and strong magnets. Designated clean room areas will prohibit food, any outside materials such as cell phones, tablets, at a minimum.Compensation Overview:Summit West - NJ - US: $103,560 - $125,495 Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolBMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.Supporting People with DisabilitiesBMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.Candidate RightsBMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.Data ProtectionAny data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.