HireDiversity

Raritan, NJ, US

Senior Scientist-2241121207

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 Scientist will execute analytical testing according to testing schedules in a productive, compliant and efficient manner, and adhere to laboratory procedures, cGMPs, DEA, and EH&S requirements. This individual will ensure proper calibration and instrument verification is performed prior to use, may execute test scripts for systems validation, and suggest ideas for improvement and support continuous improvement efforts in the lab. This individual will serve as SME for analytical instruments or laboratory processes. The Senior Scientist will work in an organized and safe manner and assure work area and laboratory equipment are well-organized, clean and maintained. The Senior Scientist will oversee and independently evaluate and trend data, provide technical expertise to junior lab analysts on technical and business issues, and serves as a role model for cooperation and teamwork. This individual may lead projects, and make independent decisions on routine issues. Decisions on non-routine issues are made in consultation with the supervisor. The Senior Scientist may lead laboratory investigations and ensure a compliant and thorough investigation is conducted. This individual will perform troubleshooting of analytical issues that may arise and conduct/document scientifically sound, thorough laboratory investigations that will hold up to health authority scrutiny. The Senior Scientist may develop, collect and report metrics related to testing, and support and occasionally train other analysts. He/she will author lab SOPs and equipment, work instructions, and lead 5S and lean concepts and participate in industry and trade association groups (e.g. PSDG, USP, ICH, etc). The Senior Scientist will perform peer review and review of analytical technical documents (e.g. technical justifications, specifications, methods, transfer protocols, reports, etc.) and ensure appropriate volume of lab supplies and reference standards are available for testing. This individual will support Stability Integrator/Stability Owner, when necessary, including creating APR reports, understanding Stability requirements (e.g., ICH stability program management and specification setting).

Qualifications


Bachelor of Arts or Science with a minimum of 5 years experience or a Masters Degree with a minimum of 3 years experience in an analytical laboratory is required. Demonstrated proficiency in HPLC is required. Experience with the following instrumentation is preferred (UPLC, Dissolution). Strong knowledge in chromatography and analytical chemistry knowledge in a GMP environment is required. The ability to troubleshoot analytical equipment is preferred. Proficiency with laboratory systems (e.g., Empower, LIMS, event/CAPA management, etc.) is preferred. Knowledge of current stability guidelines and industry standards is required. Experience in performing and documenting laboratory investigations is preferred.

The Senior Scientist should be customer oriented, able to maintain successful team relationships, and has a high sense of responsibility regarding professional activities. The ability to work in a deadline driven, GMP-regulated environment is required. This individual will promote knowledge sharing within the area, possess strong communication and interpersonal skills, good technical writing skills, and the ability to multi-task. He/she will also have good organizational skills, presentation skills, project management skills, and networking skills. A positive/optimistic attitude with the ability to be flexible, adaptable, and amenable to change is necessary, along with a commitment to timeframes. The Senior Scientist must also be pro-active, creative, and accurate, with an analytical and quality mindset and the ability to serve as a technical leader. 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 Control