"Alerted.org

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.jnj.com

Job Function:

Quality

Job Sub** **Function:

Quality Control

Job Category:

People Leader

All Job Posting Locations:

Spring House, Pennsylvania, United States of America

Job Description:

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.

Key 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

Qualifications:

Education:

+ Minimum of a Bachelor’s or equivalent University Degree required; focused degree in Biology, Biochemistry, Microbiology, Chemistry or related field is preferred.

Required:

+ 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

Preferred:

+ 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)

Other:

+ **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

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 https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills: