Shift: (Sun-Wed 7am-5:30pm)Location: Morris Plains, NJ Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.Key Responsibilities: Perform Bioanalytical testing in support of clinical and commercial release strategies.Acts as liaison for other departments and/or external stakeholders in support of non-standard testing regimesExecute and supervise peer review of analytical data.Support and manage tracking and trending systems, and programs which assist in the testing, evaluation and monitoring of quality, assay performance and efficiency.Drives execution of method qualification/development & optimization/transfer as governed by protocols and/or under the supervision of senior lab staff.Contribute, supports and lead writing of change controls, OOS/OOE/OOT and deviation investigations.Supports laboratory management in drafting analytical response/strategy documents.Assists and supervises equipment and metrology teams in troubleshooting equipment issuesRevise and/or create SOPs, forms, laboratory test records as required using appropriate electronic systems.Support internal and external audits of facility as a recognized SME.Key performance indicators: Flawlessly delivers quality results on time to all customers, internal and external. Essential Requirements: Minimum of 5 years' experience in the Pharmaceutical/Biotechnology industries conducting QC testing, release testing and coordinating the activities of a QC laboratory.Thorough knowledge of cGxP expectationsThorough general knowledge of bioassay test methods (e.g. Elisa, Flow cytometry, qPCR, cell culture)SME level knowledge of a particular area of bioanalytical testingExperienced in writing OOS/OOE/OOT, and/or deviation investigationsKnowledge of LIMS systems.Experience in supporting internal and/or external laboratory auditsAdvanced written and verbal communication skills as well as advanced experience in the use of computer-based systems and applications associated with bioanalytical testingDesirable Requirements:Knowledge of ICH, Eur. Ph., USP and FDA and JP guidelines preferred, but not necessaryExperience writing change controls preferred, but not necessaryLanguages:English.Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-cultureThe pay range for this position at commencement of employment is expected to be between $97,600 and $146,400/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factorsYou’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. Handbook. https://www.novartis.com/careers/benefits-rewardsCommitment to Diversity and Inclusion:Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patient and communities we serve. Join our Novartis Network:If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:https://talentnetwork.novartis.com/network
Location: Morris Plains, NJ
Posted: Aug. 16, 2024, 4:18 a.m.
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