HireDiversity

Raritan, NJ, US

Senior Supervisor-4991121207

Description

Janssen Supply Group, LLC is part of Janssen Supply Chain, a global organization responsible for supplying medicines to markets around the world. With Quality as their primary focus, this group strives to provides access and affordability through innovation and strong collaboration with their R&D and Commercial partners to deliver life changing solutions for patients in need.

Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer's disease, epilepsy, migraine prevention and treatment), pain management, and women's health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market - from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.com

The Senior Supervisor will supervise a team of laboratory analysts for stability testing of pharmaceutical drug products. This individual will coordinate and perform routine stability testing, investigation testing and method transfers, as well as review data, trend data, and make decisions on data acceptability. The Senior Supervisor will perform and/or direct investigations, authorize reanalyses and develop direct reports for investigations. He/she will support lean culture, drive continuous improvement projects, and lead projects related to the laboratory processes. This individual may author or approve laboratory-controlled documents, e.g., laboratory SOPs, change controls, equipment work Instructions; and may review analytical technical documents (e.g., technical justifications, specifications, methods, transfer protocols, and reports). The Senior Supervisor will interact with internal and external customers to resolve issues and provide stability expertise for projects and problem-solving/historical trending of product. This individual will ensure appropriate volume of lab supplies and reference standards are available for testing, ensure proper calibration and instrument verification is performed, enforce lab EHS and safety procedures, and support the Credo. He/she is responsible for testing assignments and scheduling, will assure personnel are trained and laboratory is maintained, as well as make personnel decisions related to the laboratory staff. The Senior Supervisor will provide technical guidance to the lab staff, leading or assisting with troubleshooting analytical issues, and identify/communicate any potential issues to manager. He/she will ensure and enforce lab cell's adherence to JSC global and local procedures are followed as well as cGMPs, EHS, DEA requirements. The Senior Supervisor may participate in industry and trade association groups (e.g., PSDG, USP, ICH).

Qualifications


Bachelor of Arts or in Science in related science or equivalent with a minimum of 6 years experience in an analytical laboratory (R&D, QC or Stability) is required. Significant analytical chemistry knowledge in a GMP environment is required. Demonstrated proficiency in analytical instrumentation (UPLC, HPLC, GC, Dissolution/Release, Rate, UV, viscosity) is required. Experience with Minitab required. Must have basic understanding of statistical principles, be able to perform statistical evaluation of data, and be able to troubleshoot and resolve technical laboratory or analytical-related issues. Prior supervisory experience is preferred. Must have experience with laboratory IT systems, e.g. Empower, LIMS, change control, event management/CAPA systems. This individual must have flexibility to travel between Raritan, NJ and Titusville, NJ as needed.

Primary Location:North America-United States-New Jersey-Raritan
Other Locations:North America-United States-New Jersey-Titusville
Organization: JANSSEN SUPPLY GROUP, LLC (6046)
Job Function: Quality Assurance