Supervisor, In Process Testing Lab

Johnson & Johnson Innovative Medicine•Spring House, PA

6d•Onsite

About The Position

Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting a Supervisor for In Process Testing Lab at the Spring House Facility. Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine Are you interested in joining a diverse and dynamic team that is helping improve patient care and drive innovation? Apply today for this exciting opportunity! The Supervisor, In Process Testing Lab (IPL) leads all aspects of day-to-day activities for the lab activities, ensuring GMP compliance, accuracy and timeliness of specified testing processes. The Supervisor carries out duties in compliance with all local, state and federal regulations and guidelines (including FDA, EPA, and OSHA) as well as all company and site policies and procedures. This position is responsible for carrying out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, training employees, appraising performance, rewarding and disciplining employees, addressing complaints and resolving conflicts. This position also provides guidance and support throughout the Janssen Supply Chain (JSC) for new initiatives, projects, product transfers and regulatory inspections. This position also oversees sample management, equipment lifecycle management, eLIMS, capacity planning and performance management, and QC systems administration for the SH facility.

Requirements

Minimum of a Bachelor’s or equivalent University Degree required; focused degree in Biology, Biochemistry, Microbiology, Chemistry or related field is preferred.
Minimum of 2 years of leadership experience, or equivalent
Minimum of 2-4 years of relevant experience in medical device, biopharmaceutical or pharmaceutical industry
Knowledge of basic and advanced analytical methodologies within the functional laboratory
Advanced knowledge/experience with regulatory requirements, policies and guidelines
Advanced knowledge/experience with data integrity fundamentals
Significant experience with document reviews and regulatory inspection processes
Advanced knowledge of Quality systems
Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the CRS laboratory and ability to identify gaps in processes or systems
Knowledge and awareness of compendial (USP, EP, JP, etc.) requirements and standards for testing
Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint)
Prior people leadership experience
Requires ability and flexibility to accommodate unplanned overtime (including nights and weekends) on little to no prior notice outside of Monday-Friday 8:00AM to 4:30PM.
Requires the physical ability to lift up to 20 lbs, stand or sit for extended periods of time in a laboratory setting
Requires up to 5% of domestic travel
Position is located in Spring House, PA

Nice To Haves

Demonstrated history of taking initiative and being proactive towards projects
Minimum of 1 year experience with instruments used in CAR-T therapies (Flow cytometry, NC200, XM30 etc).
Extremely motivated and passionate in leading the CREDO activities and be the active member of the organization
Advanced knowledge of applicable computer systems (SAP, tableau, MES)

Responsibilities

Responsible for the efficient and effective functioning of the Spring House IPL lab day-to-day activities including the planning, coordination and direct supervision of activities conducted by the Spring House team.
Acts as primary contact for the Spring House IPL Lab for services conducted within the organization.
Maintaining a safe work environment in compliance with all applicable environmental, health, and safety regulations
Review/approve QC laboratory data for validity and accuracy according to cGMP/cGLP standards
Approve invalid assay and general laboratory investigation records
Set priorities and manage work assignments
Train, develop, coach and mentor employees
Manage performance of staff and take disciplinary action, where required
Generates schedules to ensure efficient coverage for all operational needs.
Maintain individual training completion in a compliant state
Complete corrective and preventative actions (ACTs) as assigned
Independently complete and manage change control processes
Support Health Authority inspections
Review/approve documents as needed
Ensures laboratory equipment is qualified, maintained and calibrated, as required
Provides support for troubleshooting equipment
Maintain an orderly laboratory
Review/approve purchase requisitions for laboratory supplies
Remaining current in skills and industry trends
Develop business cases for capital projects associated with the CRS laboratory