Director Quality Control

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Janssen Pharmaceutical a member of Johnson & Johnsons Family of Companies is recruiting for a Director of Quality Control CAR-T Manufacturing! This 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.

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.

The Quality Control Director for an Advanced Therapy CAR-T facility leads the relevant laboratories in order to deliver testing and release while maintaining an environment of continuous improvement customer focus and awareness of business needs. This role supports a diverse lab group which provides key services to the wider Advanced Therapies platform as well the Lenti and CAR-T local facilities. The role crafts long-term strategies and advises a team of managers within the overall Quality Control department. Experience in the following:Analytical Testing Microbiological testing in-process testing & Quality control excellence/lab support.

Key Responsibilities:

• Develops and implements strategy for cGMPs compliance for the site.
• Provides leadership and direction to Quality Control Team to ensure business quality and compliance goals are met following the J&J Standard of Leadership behavior model.
• Develops and champions an organizational culture that promotes behaviors that lead to outstanding business performance and organizational excellence.
• Responsible for appropriately staffing and developing the QC organization to meet business needs and succession plans.
• Leads launches of new products and technology transfer across the platform.
• Anticipates and plans for future requirements and agility in the Labs including such aspects as procedural requirements capital planning personnel recruitment planning compliance requirements efficiency and optimization objectives and anticipated changes needed to reflect future demand.
• Establishes effective partnerships with other individuals departments and cross- functional teams so that analytical services are well understood and coordinated.
• Establish proper communication channels to lead and mentor employees to higher levels of management capability and provide strategic leadership to further strengthen the QC operations.
• Develops and controls budget organizational structure and business requirements to accommodate budget and assure metrics are met.
• Ensure all activities are performed in accordance with GMP in the laboratories and monitor QC compliance through robust internal audit and leadership oversight programs (e.g. GEMBA).

Qualifications - External

Education:

A minimum of a bachelors degree in Science is required preferably in Biology Microbiology Chemistry Pharmacy Biochemistry or related Science or Engineering.

Required:

• 10 years of proven track record in biologics and/or cell therapy Quality Control laboratory operations with 5 of those years managing at the senior level.
• Demonstrated success in leading a large scale QC lab.
• Experience in hosting global regulatory agency inspections and successfully communicating quality control programs to regulatory reviewers.
• Experience with Trackwise and eLIMS.
• Excellent communication interpersonal relation collaboration and influencing skills.

Other:

• This position may require up to 10% domestic travel

Johnson & Johnson is an 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 disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via . internal employees contact AskGS to be directed to your accommodation resource.

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