CAR-T Manufacturing Operator
Company: Disability Solutions
Location: Raritan
Posted on: April 20, 2024
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Job Description:
Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's
Family of Companies, is recruiting for a CAR-T Manufacturing
Operator located in Raritan, NJ. #CART At Johnson & Johnson, we
believe health is everything. Our strength in healthcare innovation
empowers us to build a world where complex diseases are prevented,
treated, and cured, where treatments are smarter and less invasive,
and solutions are personal. Through our expertise in Innovative
Medicine and MedTech, we are uniquely positioned to innovate across
the full spectrum of healthcare solutions today to deliver the
breakthroughs of tomorrow, and profoundly impact health for
humanity. Learn more at . POSITION SUMMARY: This position is
responsible for performing manufacturing procedures and the
execution of scheduled tasks within a CGMP environment. This
position is responsible for quality and maintaining the highest
standards in compliance with company policies, procedures, and all
applicable regulations. Responsible for fostering site pride and
J&J citizenship. ESSENTIAL FUNCTIONS: --- Be part of the
manufacturing operations team responsible for the production of
autologous CAR-T products for clinical and commercial operation in
a controlled current Good Manufacturing Practice (cGMP) cleanroom
environment. --- Independently execute manufacturing or
manufacturing-support processes according to standard operating
procedures and current curriculum. --- Execute manufacturing
activities common to cell culturing, purification, aseptic
processing, and cryopreservation using appropriate techniques. ---
Perform process unit operations according to standard operating
procedures and batch records, and record production data and
information in a clear, concise, format according to Good
Documentation Practices (GDP). --- Work in a team-based,
cross-functional environment to complete production tasks required
by shift schedule. --- Aid in the development of manufacturing
processes including appropriate documentation. --- Drive continuous
improvement of manufacturing operations leveraging own observation
as well as input of team members. --- Handle human-derived
materials in containment areas. --- Support schedule adjustments to
meet production. --- Accurately complete documentation in SOP's,
logbooks, and other GMP documents. --- Demonstrate training
progression through the assigned curriculum. --- Accountable for
maintaining a working knowledge of basic cGMP requirements to
ensure adherence to compliance policies and regulations. --- Wear
the appropriate PPE when working in manufacturing and other
hazardous working environments. --- Proactively maintain a clean
and safe work environment. Take necessary action to eliminate
safety hazards and communicate to others any observed unsafe
behaviors. --- Ensure materials are available for production. ---
Perform tasks on time in a manner consistent with quality systems
and cGMP requirements. ADDITIONAL RESPONSIBILITIES/DUTIES: ---
Support the ongoing production schedule by: O Report to work on
time and according to the shift schedule. O Perform other duties as
assigned. O Attend departmental and other scheduled meetings. O
Practice good interpersonal and communication skills. O Demonstrate
a positive team-oriented approach in the daily execution of
procedures. O Promote and work within a team environment. O Learn
new skills, procedures, and processes as assigned by management and
continue to develop professionally. --- Support investigation
efforts as required. --- Responsible for audit preparation and
participation. *This is not an exhaustive or comprehensive listing
of job functions. May perform other duties as assigned. AUTONOMY
and COMPLEXITY:
Keywords: Disability Solutions, Plainfield , CAR-T Manufacturing Operator, Other , Raritan, New Jersey
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