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Johnson & Johnson Innovative Medicine · 4 hours ago

Supervisor, In Process Testing Lab

Spring House, PA

Full-time

Onsite

Mid, Senior Level

4+ years exp

Johnson & Johnson is a leader in healthcare innovation, dedicated to improving patient care. The Supervisor for In Process Testing Lab will lead day-to-day lab activities, ensuring compliance with regulations and managing staff performance.

Pharmaceuticals

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

Qualification

Analytical methodologiesRegulatory requirementsQuality systemsCGMP knowledgeLeadership experienceDocument reviewData integrityMicrosoft OfficeCAR-T instrumentsSAPTableauMESInitiative

Required

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