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

Overview

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

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.

• 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 maintenance, 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 GDPs.
• Performs 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.
• 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, with Team Lead acting as Supervisor when needed.
• Maintains on-time completion of training assignments and those of associates to ensure the necessary technical skills and process knowledge in GMP.
• Performs other tasks as assigned; leads continuous improvement projects, inspection readiness, and right-first-time initiatives.

This position reports to the Manufacturing Manager.

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

• Bachelor's degree and 2-4 years of experience in cell therapy or Biopharmaceutical operations.
• Associate / Medical Technical degree and 6+ years of Manufacturing

• High School diploma/GED and 8+ years of Manufacturing or Operations experience.

• Intermittent walking and sitting; ability to sit or stand for extended periods may be necessary.
• Must be comfortable working with contained human blood components.
• Physical dexterity to use computers and documentation.
• Sufficient vision and hearing capability for the work environment.
• Ability to lift 25 pounds.
• Must have the ability to work around laboratories and controlled, enclosed areas.
• Cleanroom garments and PPE required in designated areas.
• Prohibitions on makeup, gum, nail polish or other potential microbial sources in restricted areas.
• Flexibility to don clean room garments and PPE.
• Clean room environment is an enclosed, restricted space with assigned pressure and temperature.
• Reagents, chemicals, and sanitization agents exposure expected.
• Routine exposure to human blood components; exposure to strong magnets is likely.
• Designated areas may prohibit food and outside materials (e.g., cell phones, tablets).
• Other standard statements about job duties and responsibilities.

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.

Summit West - NJ - US $71,321 -…