Investigator, PK Sciences BioAnalytics job in East Hanover
|Employer:|| Novartis Pharmaceuticals|
|Category:||Research and Development|
|Job Type:||Full Time|
|State:||New Jersey (NJ)|
The Novartis Institutes for BioMedical Research (NIBR) is the innovation engine of Novartis, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients. NIBR includes about 6500 associates across 7 locations worldwide. Translational Medicine (TM) is the clinical research arm of NIBR, and includes about 1000 associates globally. TM plays a pivotal role in bringing innovative medicines to patients, by building on research advances to develop new therapies, and bridging drug discovery and clinical application. PK Sciences (PKS) partners across both NIBR and the Global Drug Development organizations to advance the scientific knowledge of pharmacokinetics, metabolism and clinical pharmacology, and bring it to bear on drug discovery and development challenges throughout R&D. |
As part of an integrated preclinical Bioanalysis (BA) and Toxicokinetics (TK) team, the successful candidate will be responsible for scientific input of bioanalytical and toxicokinetic strategy for the assigned projects/studies across various therapeutic areas for Novartis drug development. The candidate will serve as a Subject Matter Expert (SME) to monitor various BA and TK activities at Contract Research Organizations (CROs). The activities include but are not limited to: (1) development and validation of LC-MS BA methods and associated study (GLP and non-GLP) sample analysis for small and large molecule drug candidates in preclinical species matrices, (2) TK interpretation and summary based on the obtained bioanalytical data in support of preclinical studies, (3) reporting of BA method validation, sample analysis and TK. The position requires an individual to be proficient in using multiple instrument software programs and, particularly, laboratory information management system (LIMS) for calibration regression, quantitation of raw data, study review, and TK calculation, (4) regular collaboration with project team members, line functions, and CROs for scientific input/review, study planning and logistics. The candidate should understand key principles underlying relevant technologies and protocols in respective discipline and closely related areas. Excellent communication skills are required for this role. Knowledge in monitoring GLP ligand binding assays, ADA screening, Nab assay development would be considered an asset.
Key Activities include:
• Calculate, summarize, report and/or present TK for various drug candidates in preclinical species
• Monitoring and review of LC-MS BA method development and validation, and TK and preclinical ADME studies and the associated reporting in support of IND and NDA.
• Serve as subteam member for the assigned projects, work with key stakeholders to execute preclinical bioanalytical and TK strategy and ensure performance metrics are maintained.
• In collaboration with the QA department, conduct GLP site audit and qualification as a Subject Matter Expert in bioanalysis and TK.
• Collaborate effectively and efficiently with internal customers and external service providers in order to establish good working relationships while ensuring high quality deliverables in a timely fashion.
• Independently conduct LC-MS bioanalytical work with scientific integrity and quality to meet timelines for pre-clinical studies as needed.
• Troubleshoot advanced method development for new modalities as appropriate.Minimum requirements:
• M.S. or PhD in Analytical Chemistry, Organic Chemistry, Biochemistry or related field with a minimum of 4 years of relevant industrial experience.
• Extensive experience in GLP LC-MS bioanalysis and proficiency with Watson LIMS, TK calculation using Watson LIMS and TK data interpretation are essential.
• Well-understand the current regulatory requirements in bioanalysis in drug development from a global perspective.
• Working experience with electronic laboratory notebook and Microsoft Office product suite are required.
• Excellent hands-on experience in LC-MS techniques, LC-MS bioanalytical method development, trouble shooting and validation is essential. A strong background in LC-MS bioanalysis of difficult modalities (e.g., proteins, oligos) is preferred.
• Detail and solution-oriented in daily operation.
• Well-developed interpersonal skills with excellent oral and written communication skills.
• Good planning, prioritization, problem solving, organizational and multi-tasking skills Open-minded, self-starting, decisive, persuasive and confident in nature.
• Resilient, energetic and enthusiastic; responding constructively to challenges.
• Team player with ability to be flexible, adapt to a changing environment and succeed through influence.