Specialist, Team Lead, Abecma CAR-T

At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through (link removed) oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.


Purpose and Scope of Position:
Manufactures human blood derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing Team Leads assist shift personnel and 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 applies to all Quads:1,2,3 and 4, Thurs-Saturday, every other Wednesday 6 am-6 pm. Shifts ar 6 am-6:30 pm, or 6 pm-6:30 am. Start and end times are subject to change based on business demands. Reports to Business Unit Owner: Isolation/Harvest, Aseptic Operations or Expansion.
Required Competencies: Knowledge/ Skills, and Abilities:

Advanced understanding of cell culture, cell expansion and aseptic processing or lab techniques within a cleanroom.
Familiarity with Lean Manufacturing initiatives
Knowledge of cGMP/FDA regulated industry requirements
Basic mathematical skills
Technical writing capability to support batch record revisions, deviation investigations, and closure of CAPAs.
Proficient in MS Office applications
Background to include an understanding of biology, chemistry, medical or clinical practices
Must be a Qualified Trainer in Expansion Operations with ability and willingness to train others

Duties and Responsibilities:

Oversee set-up and operation of equipment to support production of blood component lots through culture expansion, cell counting, data entry and media addition while maintaining good aseptic technique.
Lead deviation investigations and write ups as needed. Accountable for on time closure of any assigned CAPAs within the designated shift.
Good aseptic technique is required for most activities: tube welding, connections, and transfers, at minimum.
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.
Must be highly motivated, team oriented with strong patient focus 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.
Lead shift daily review and correction of all logbooks in the processing suites
Performs other tasks as assigned: Lead continuous improvement projects, inspection readiness, right first-time initiatives, etc.
Issue pre/post shift reports and escalate issues for timely resolution

Education and Experience:

Masters degree plus 1-2 years of experience in cell therapy or biopharmaceutical operations
OR Bachelors degree plus 2-4 years of experience in cell therapy or biopharmaceutical operations
OR Associate/ Medical Technical degree and 6+ 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.
Physical dexterity sufficient to use computers and documentation.
Sufficient vision and hearing capability to work in job environment.
Ability to lift up to 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.
Restricted areas prohibit food, any outside materials such as cell phones, tablets, at a minimum.

BMSCART
VETERAN
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Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

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