- Be part of the manufacturing operations team responsible for cryopreservation and clinical and commercial preparation of autologous CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment.
- Independently execute Cryopreservation or manufacturing-support processes according to standard operating procedures and current curriculum.
- Execute manufacturing activities every day for 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).
- Perform tasks on time consistent with quality systems and cGMP requirements.
- 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 and input of team members.
- Handle human-derived materials in containment areas.
- Support schedule adjustments to meet production.
- Accurately complete documentation in SOPs, 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 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.
- Support the ongoing production schedule by:
- Report to work on-time and according to the shift schedule.
- Perform other duties as assigned.
- Attend departmental and other scheduled meetings.
- Practice good interpersonal and communication skills.
- Demonstrate positive team-oriented approach in the daily execution of procedures.
- Promote and work within a team environment.
- 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.
- Needs direction to perform manufacturing daily tasks within functional area.
- Support and contributes to projects.
- Assist in troubleshooting routine manufacturing processes.
- Support and execute non-routine manufacturing activities.
- Basic technical knowledge within functional units
- Demonstrate a basic understanding of the process to properly perform the assigned manufacturing tasks.
- Basic understanding and working knowledge of systems required per curriculum. Utilizes tools within MS Office and other systems to improve business effectiveness.
- Accurate Data Entry skills in relevant manufacturing applications (SAP, electronic batch records (EBR), etc
- HS Diploma required with 4-6 Years of Biotech/Pharmaceutical experience or equivalent industry experience. OR
- Associate degree required with 2-4 Years of Biotech/Pharmaceutical experience or equivalent industry experience. OR
- Bachelor's degree required in Life Sciences or Engineering, with 0-2 years of Biotech/Pharmaceutical experience or equivalent industry experience.
- Read and interpret documents such as safety rules, operating instructions, and logbooks
- Review and provide feedback for SOP and Batch Record Revisions
- Interpret a variety of instructions furnished in written, oral, diagram or schedule form.
- Follow instructions
- Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Add, subtract, multiply and divide in all units of measure, using whole numbers, common factions, and decimals.
- Knowledge and ability to operate manufacturing, manufacturing-support, and lab equipment.
- Knowledge of Process Excellence Tools
- Possesses solid knowledge of routine and non-routine testing and sampling methods, techniques, and related equipment.
- The anticipated base pay range for this position is $49,088 to $66,413 annually .
- This position is overtime eligible
- Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal, and family time off in accordance with the terms of the applicable plans.
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Cryopreservation Manufacturing Operator - Raritan, United States - Johnson & Johnson
Description
Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a MFG Operator Cryopreservation CAR T located in Raritan, NJ . #CARTAt Janssen, we never stop working toward a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, and you can count on us to keep working tirelessly to make that future a reality for patients everywhere, by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Arterial Hypertension.
POSITION SUMMARY:
This position is responsible for performing manufacturing procedures and executing 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:
ADDITIONAL RESPONSIBILITIES/DUTIES:
AUTONOMY and COMPLEXITY:
NATURE OF TASKS:
Manufacturing Operator:
Computer ABILITY:
EDUCATION AND EXPERIENCE:
LANGUAGE SKILLS:
REASONING ABILITY:
MATHEMATICAL SKILLS:
OTHER SKILLS, ABILITIES OR QUALIFICATIONS:
PHYSICAL DEMANDS:
While performing the duties of this job, the employee:
Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position.
Is frequently required to communicate with coworkers.
While performing the duties of this job, the employee is regularly required to stand; walk; climb, bend, and stoop; and reach with hands and arms.
Ability to lift 25 lbs.
Needs to perform gowning procedures to work in manufacturing core.
*The Raritan CAR-T Manufacturing organization is committed to working with any applicant or employee to make reasonable accommodations in job structure in consideration of any known physical challenges or disabilities.
*The Raritan CAR-T Manufacturing organization is committed to working with any applicant or employee to make reasonable accommodations in the job structure in consideration of any known physical challenges or disabilities.
Additional Information:
About Johnson & Johnson:
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That's why for more than 135 years, we have aimed to keep people well at every age and every stage of life. Today, as the world's largest and most diversified healthcare products company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere.
Every day, our more than 150,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.
