Sr. Scientist Bioanalytics (Deviations)

The Novartis Cell and Gene Technical development and Manufacturing team is seeking a Sr. Scientist Bioanalytics (Deviations) in Morris Plains, NJ.
In this role, the Bioanalytics Senior Scientist will support compliance-related activities within the Bioanalytics department as well as support ongoing international process transfer and stewardship.
Independently, execute, direct and assist in functions supporting the Bioanalytics department. Duties include: ‚€ĘLead and perform OOS/OOE/OOT investigations and deviations supporting Bioanalytics department operations ‚€ĘPerform Change Control activities such as initiation, change phase management, and impact assessments supporting groups outside the Bioanalytics department ‚€ĘSupport ongoing analytical stewardship of international contract manufacturers ‚€ĘTrain on Bioanalytics methods to build a knowledge base to support compliance-related activities ‚€ĘTo support both domestic and international activities, working off shift or weekends may be necessary. ‚€ĘKnowledge and familiarity of SAP systems, including Quality Module (QM). ‚€ĘKnowledge and familiarity of LIMS systems (Labware Lims) ‚€ĘKnowledge and familiarity of eSOPS and TEDI. ‚€ĘDrive 5S and lean projects ‚€ĘEnsure conformance to in-house specifications and GMPs ‚€ĘPerforms training of new associates ‚€ĘAssist in troubleshooting problems on lab instruments and analytical methods ‚€ĘAuthors new and revises existing cGMP documents to ensure compliance ‚€ĘPerform review and release of test work. ‚€ĘOther duties as assigned Additionally, maintains GMP and GLP systems and environment, as well as ensures that all safety requirements are met for the lab areas.
Work with biohazardous agents such as human cells, Lentiviral Vector, Human AB serum. May need to adapt to changing work shifts, both swing and/or graveyard on very short notice May use a computer for extended periods (up to 6 hours).
EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Minimum requirements BS or MS in biology, chemistry, biochemistry, microbiology or other related science. English Minimum of 5 years experience in the pharmaceutical/Biotechnology industries. Relevant experience would include: execution of OOS/OOE/OOT investigations and understanding the Change Control process within a GMP environment, conducting QC testing, release testing, coordinating the activities of a QC laboratory, and experience with method transfer. Knowledge of cGMP, USP and FDA guidelines. Thorough knowledge of bioassay test methods, as appropriate. Knowledge of LIMS systems. Knowledge of Change Control systems, such as Agile PLM Knowledge of Quality Management Systems, such as Trackwise Ability to communicate clearly with a variety of individuals in various aspects of Novartis operations. Detail-oriented with expertise in problem solving and solid decision making abilities. Strong written and verbal communication skills are essential.

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