Johnson & Johnson Careers

Senior Associate Scientist, CAR-T Support

Spring House, Pennsylvania
R&D


Job Description

Requisition ID: 1857190104

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Senior Associate Scientist, located in Spring House, PA.

 

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.

 

We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal.  Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

 

The CAR T Support Scientist will be a technical guide supporting the manufacturing of biological products. They will provide technical expertise to ensure that atypical event and non-conformance investigations relating to production and the testing of materials and products are completed in compliance with all applicable procedures and regulations and are conducted per phase appropriate GMPs as applicable. They will understand and apply the different regulations and requirements between early and late phase clinical products, monitor and trend key process parameters to gain knowledge of an NPI to optimize the process and product. They will troubleshoot manufacturing problems as required and provide primary technical support. The individual will also identify and implement process improvements, support capital projects, site wide initiatives or other projects as needed in the capacity of a project manager or a subject matter expert and conduct technical and validation studies. This position requires strong interpersonal, communication and project management skills.
 
The individual will lead, support and provide oversight to support systems and processes used at the Spring House site, including batch record handling and inventory management (including discrepancy resolution, scrap processing, and physical inventory), Engineering File Management System, periodic review of SOP’s, equipment/plant related master data (including maintenance plans and task lists), inventory management and coordination and notification and order oversight reporting. Additional responsibilities include:
  • Provides technical support for the investigation and resolution of deviations and atypical events utilizing phase appropriate GMPs
  • Recommends, owns and implements corrective/preventative measures aimed at improving compliance, reducing repeat occurrences and addressing trends.
  • Identifies and implements process improvements related to safety, environmental, quality and compliance within the change control system. Assure regulatory compliance and technical feasibility of proposed changes.
  • Develops business cases for projects. Initiate and execute change controls. Assist with equipment startup and technical training as required. Serves as project manager for the change process and provide coordination to ensure timely and compliant implementation of process improvements.
  • Shares standard methodologies between sites
  • Provides technical support for process and validation. Assist with revalidation efforts.
  • Serves as Subject Matter Expert (SME) during internal and external regulatory audits (including FDA, EMEA).
  • Maintains various databases of production information:
  • Extract, monitor and trend process data from EMS and PI servers
  • Use databases to monitor process performance and actively troubleshoot operations.
  • Work with Automation and Information Management to improve the effectiveness of process data collection and analysis.
  • Coordinate data to support IND, IND amendments, IMPD, BLA and any other regulatory documents or dossiers needed as part of the NPI process
  • Demonstrates expertise in a number of the following areas: cGMPs, FDA regulations, sterile/aseptic processing.
  • Provide documentation support, creation/revision for SOP/ Batch Record. Review and approve SOP and Batch record revisions
  • In coordination with the manufacturing schedule, create process orders and print batch records to ensure appropriate records are available to promote flawless manufacturing execution, review and inventory transactions. resolve iDoc and COGI inventory discrepancies, conduct inventory cycle counts, and perform inventory corrections, as needed
  • Input batch record data into appropriate data sources
  • Work along with maintenance and equipment owners in creating proper maintenance plans
  • Redline, update engineering drawings, as required
  • Training of new staff members
  • Carries out duties in compliance with all company and site policies and procedures, local, state and federal regulations and guidelines including FDA, EPA, and OSHA.
  • Successfully completes regulatory and job training requirements
  • Provide other manufacturing process support as required

Qualifications
  • B.S. engineering or science, with at least 12 years of experience in a cGMP manufacturing environment, biopharmaceutical or pharmaceutical industry experience OR a M.S. engineering or science, with at least 8 years of experience in a cGMP manufacturing environment, biopharmaceutical or pharmaceutical industry experience is required
  • Experience with Quality IT systems - Trackwise, DocSpace, LIMS, Maximo are required
  • Experience with Microsoft Office software is required
  • Cell therapy experience is required
  • Must have the ability to be an active driver of innovation; think outside of the box and challenge others to do the same using a risk based approach

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.


Primary Location
United States-Pennsylvania-Spring House-1400�McKean�Road
Organization
Janssen Research & Development, LLC. (6084)
Job Function
R&D
Requisition ID
1857190104