Senior Scientist-1836140807
Description
Janssen Supply Group, a member of Johnson & Johnson's family of companies, is recruiting for a Senior Scientist, located in Raritan, NJ. After approximately 2 years this position is scheduled to move to the J&J facility in Manati, Puerto Rico.
Janssen Pharmaceuticals Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including in oncology, immunology, neuroscience, infectious disease, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency. Janssen Supply Group, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
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.
The Senior Scientist will be responsible for release, stability testing, standard qualification and in-process/investigational testing, data review and troubleshooting/investigation in commercial Quality Control operations in accordance with all applicable regulatory requirements (cGMP, EHS, ICH, WHO, etc.). This individual will independently perform analyses using a variety of instrumentation (e.g., Threshold instrument, pipet robot for ELISA, cell based/bio assay, etc.) following current methods and in accordance with cGMP and EHS standards. Accurately and timely deliver data to customers. Perform peer review of test results. Author and review of analytical technical documents (e.g., technical justifications, specifications, methods, transfer protocols, reports, investigation records, etc.). Timely closure of non-conformance reports. Independently evaluate and trend data; identify and communicate any potential issues. Independently troubleshoot analytical issues that may arise and conduct/document scientifically-sound, thorough laboratory investigations that will hold up to health authority scrutiny. Independently perform calibration and maintenance lab equipment, if required. Promptly take appropriate steps for resolution of instrument malfunctions or abnormalities. Train and mentor other analysts. Author lab SOPs and Work Instructions. Proficient in MS office and laboratory applications, e.g., Word, LIMS. Sense of urgency for project timeline and supply chain request. End to end project accountability. Assist supervisor/manager in establish priorities and guiding day to day operation of lab. Replace supervisor or team leader during holidays, sickness, etc., with regard to operational activities. Support transformation to lean culture. Drive process improvements and lead projects related to the laboratory processes.
Qualifications
A minimum of a Bachelor’s Degree in a scientific discipline is required; A focused degree in biology or biochemistry is preferred; A Master's Degree or Ph. D. degree is preferred; Working experience in the pharmaceutical or biopharmaceutical industry is preferred; Knowledge of current industry standards is preferred; Knowledge of aseptic techniques is preferred; Knowledge of cGMPs is preferred; Bio-analytical knowledge in a cGMP environment is preferred; Basic understanding of statistical principals is preferred; Knowledge of different IT systems (LIMS, Event Tracking, Change Control, etc.) is preferred; Strong interpersonal, communication, presentation skills required.
This position is currently based in Raritan, NJ. After approximately 2 years this position is scheduled to move to the J&J facility in Manati, Puerto Rico.
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J2W:LI NA
Primary Location:North America-United States-New Jersey-Raritan
Organization: JANSSEN SUPPLY GROUP, LLC (6046)
Job Function: Quality Control
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