Manufacturing Team Lead, liso cel CAR-T, Manufacturing Operations

Bristol Myers Squibb•Summit, NJ

9d•Onsite

About The Position

Working with Us Challenging. 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. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary Manufactures human blood derived components per Standard Operating Procedures (SOPs) 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. This position is for Quad 1, 5 am-5:30 pm, Sunday through Wednesday. Start and end times are subject to change based on business demands. Start and end times are subject to change based on business demands. Duties/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. Reporting Relationship This position reports to the Manufacturing Manager. Qualifications Knowledge, Skills and Abilities: 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 Pre-requisites: Senior Associate in Manufacturing Education: 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 Condition (US Only): 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. Routine exposure to human blood components. Exposure to strong magnets is likely. 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. If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Requirements

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
Senior Associate in 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.

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.

Benefits

Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

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