CAR-T CELL COLLECTION QUALITY SYSTEM LEAD

Johnson & Johnson is currently seeking a CAR-T Cell Collection Quality Systems Lead to join our TEAM! This position will be located (onsite/hybrid) in Raritan, New Jersey.
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 https://www.
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Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy.
This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment.
Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our cell therapy products? Apply today for this exciting opportunity to be part of the #CAR-T team! The CAR-T Cell Collection Quality System Lead will work with their direct manager and the technical team to ensure comprehensive assessment of nonconformances/deviations along with additional responsibilities.
Key Responsibilities.
Review and support in the completion of routine GCC and Vein to Vein investigations for starting material.
Work with process SMEs to successfully complete and close non-conformances in COMET in a timely manner.
Proactively work with cross-functional teams to ensure robustness of investigations, as well as accuracy and ensuring compliance.
Represent the department in interdepartmental meetings in support of non-conformance metrics.
Respond swiftly to departmental and interdepartmental needs and requests.
Work closely with management to propose/complete improvement activities.
Perform tasks in a manner consistent with the safety policies, quality systems, cGTP and cGMP requirements, as applicable.
Lead GCC change control management activities for cell collection sites and cryopreservation centers.
Support coordination of data collection and trend analysis as requested.
Support SME in the material equivalency workstream to qualify alternate materials Develop and revise standard operating procedures, work instructions, etc., as needed.
Provide support during health authority inspections.
Build strong partnerships and effectively integrate with collaborators to drive projects/programs.
Qualifications Education.
Minimum of a Bachelor's University or equivalent degree required; focused degree PREFERRED in Biology, Engineering, Science, or equivalent technical subject area Experience and Skills.
Required.
Minimum of four (4) years of experience in operations (cell therapy, quality or manufacturing) Demonstrated experience supporting non-conformance/investigations Excellent written and verbal communication skill Knowledge in current Good Manufacturing Practices Knowledge of current Good Tissue Practices Preferred.
Experience with aseptic processing in ISO 5 clean room and/or biosafety cabinets Knowledge of National and International manufacturing regulatory requirements (e.
., FDA/EU guidance) Experience in QC methods, cell therapy, or Research & Development Familiarity with SAP, MES (electronic batch records), Trackwise, COMET (quality event management), or equivalent systems, dashboard systems Other.
May require up 10% travel, domestically and internationally Requires ability and flexibility to accommodate shift schedule (if needed) and unplanned overtime (including nights and weekends) on little to no prior notice This job will be J&J Flex/Hybrid.
Requires the ability, through our flexible work policy, to work on-site a minimum of three days each week, with the option for two remote workdays each week The anticipated base pay range for this position is $ to $.
The compensation and benefits information set forth in this posting applies to candidates hired in the United States.
Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
The Company maintains highly competitive, performance-based compensation programs.
Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.
The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year.
Bonuses are awarded at the Company’s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs.
medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits.
Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below.
For additional general information on Company benefits, please go to.
https://www.
areers.
nj.
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This job posting is anticipated to close on January .
The Company may however extend this time-period, in which case the posting will remain available on https://www.
areers.
nj.
om to accept additional applications.
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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
om.
Apply today for this exciting opportunity!