Manufacturing Associate, liso cel CAR T, Manufacturing Operations

Manufacturing Associate, liso cel CAR T, Manufacturing Operations

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. Quad 3, 5 am‑5 30 pm, Wednesday through Saturday.

Start and end times are subject to change based on business demands.

• Perform set‑up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation.
• Support deviation investigations and write‑ups as needed. Support on‑time closure of any assigned CAPAs within the designated shift.
• Utilize aseptic technique for tubing, welding, connections, and transfers; aseptic qualification required.
• Weigh and measure in‑process materials to ensure proper quantities are added/removed.
• Adhere to the production schedule ensuring on‑time internal production logistics.
• Record 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.
• Work in a team‑based, cross‑functional environment to complete production tasks required by shift schedule.
• Be a motivated, team‑conscious individual who fulfills job requirements.
• Become an SME and qualified trainer within a designated manufacturing function.
• Under supervision by the shift Supervisor or designated Team Lead.
• Maintain on‑time completion of training assignments to maintain necessary technical skills and process knowledge.
• Perform other tasks as assigned (continuous improvement projects, inspection readiness, right‑first‑time initiatives, etc.).

This position reports to the Manufacturing Manager.

• Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or laboratory technique.
• Knowledge of cGMP/FDA regulated industry.
• Basic mathematical skills; general understanding of cGMPs.
• Technical writing capability.
• Proficiency in MS Office applications.
• Background including an understanding of biology, chemistry, medical or clinical practices.
• Prior experience in manufacturing and/or scientific/engineering education.

• Bachelor's degree.
• Associate/Medical Technical degree and 2 years of manufacturing.
• Operations experience.
• High School diploma/GED and 3 years of manufacturing or operations experience.

• Intermittent walking and sitting to perform job functions; ability to sit or stand for extended periods may be necessary.
• Must be comfortable working with contained human blood components.
• Physical dexterity sufficient to use computers and documentation.
• Vision and hearing capability to work in the job environment.
• Ability to lift 25 pounds.
• Required to work around laboratories and controlled, enclosed, restricted areas.
• Cleanroom garments and personal protective equipment (PPE) required in designated areas.
• Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.
• Flexibility to don clean‑room garments and PPE.
• Clean‑room environment is an enclosed, restricted space with assigned pressure and temperature conditions.
• Exposure to reagents, chemicals, and sanitization agents expected.
• Routine exposure to human blood components; exposure to strong magnets likely.
• Designated areas may prohibit food and outside materials such as cell phones and tablets.
• Job description describes general nature and level of work; additional duties may be assigned 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.

Summit West — NJ — US $27.83 - $33.72 per hour.

The starting compensation range is…