Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a CAR T Cell Collection Quality Lead. The position will be located in Raritan, NJ.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Primary Responsibilities include:
- Support the establishment and implementation for apheresis cryopreservation operations.
- Be part of the QA team responsible for oversite of autologous CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment.
- Establish and implement cGMP procedures to cryopreserve fresh apheresis material.
- Oversee the execution of unit operations according to standard operating procedures and batch records.
- Review recorded production data and information and ensure the data is clear, concise, and formatted according to Good Documentation Practices (GDP).
- Perform tasks on time in a manner consistent with the safety policies, 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 as well as input of team members.
- Conducts QA review and approve all manufacturing/processing batch records and quality test records.
- Ensures completeness and accuracy of all files received into Quality Assurance, according to SOP and to meet state and federal regulatory requirements.
- Ensures readiness of records for regulatory inspection.
- Completes and provides data for Continuous Quality Improvement for all batch and quality test records per SOP.
- Revises existing standard operating procedures as needed for annual review and process changes.
- Reviews proposed changes to existing Standard Operating Procedures as needed.
- Assists in the review and release of raw materials for use in the manufacturing/laboratory area.
- Coordinates back room activities for Regulatory Inspections.
- Reviews, compiles and organizes data for trending.
- Aids other QA staff members as needed.
- Performs other QA duties as assigned.
- Bachelor’s degree with at least six (6) years of related experience OR a Master’s degree with at least four (4) years of related experience is required.
- Experience in with Cell or gene therapy required.
- Experience with 210, 211, 1271, 600.
- Previous experience in QA within a GTP and GMP lab environment preferred.
- Experience in the Pharmaceuticals or Biopharmaceuticals industry is preferred.
- Knowledge of current Good Manufacturing Practices (cGMP) is required.
- Experience in writing, reviewing and implementing cGMP documents required.
- Experience in an aseptic and manufacturing environment is preferred.
- Proficiency in English (verbal and written), as well as, good communication skills are required.
- Ability to lift a minimum of 25 lbs. and to stand for a long period of time are required.
- Basic proficiency with Microsoft Office tools (Word, Excel, PowerPoint and Outlook) is required.
- Availability to work in a day shift (1st or 2nd shift) and ability to accommodate changes in the schedule including working in other shifts as per operational needs is required.
- This position will be based in Raritan, NJ and requires up to ten percent (10%) of domestic travel.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-New Jersey-Raritan-
Janssen Pharmaceuticals, Inc. (6062)