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Manager, QC Bioanalytics

The Novartis Cell and Gene Technical development and Manufacturing team is seeking a Manager, QC Bioanalytics in Morris Plains, NJ.
The Manager, QC Bioanalytics will coordinate and lead all activities to ensure the timely testing and release of all samples, Lead the design and execution of validation and other major projects. Deliver quality products and services on time to all customers, internal and external. Provide employees with training and resources to meet or exceed customer requirements. Monitor processes and products to identify opportunities for continuous improvement. Serve as the subject matter expert on specific areas and techniques. Lead a group of lab associates and represent QC leadership. Set up organizational structures to improve efficiency and throughput. Engage in projects to assure GMP beyond compliance.
Under general direction, direct and assist in functions supporting the Quality Control department. Du-ties include: •Primary point of contact for troubleshooting / Communication to Management during shifts •Review and approval of Batch documentation (CofA) •Lead and perform OOS/OOE investigations •Lead deviation investigation /CAPA implementation and ensure timely closure. •Supervise testing following appropriate protocols, test methods, and compendia (United States Pharmacopoeia (USP), American Chemical Society (ACS)). •Supervise Bio-Analytical testing such as Flow, ELISA, cell count, cell viability, residual bead assessment, Potency and qPCR. •Work on shifts covering daytime / evening and one or both weekend days. •Leads the development, revision, application, maintenance, validation and review of quality standards, documents and methods for processing and/or ensuring quality in intermediates or finished products. •Maintain all test methods and specifications compliant with current USP/NF. •Knowledge and familiarity of SAP systems, including Quality Module (QM). •Knowledge and familiarity of LIMS systems (Labware LIMS) and Trackwise •Knowledge and familiarity of eSOPS and TEDI. •Assure qualification status of critical reagents •Drive 5S and lean projects •Possess CSV validation experience/documentation experience •Ensure conformance to in-house specifications and GMPs •Ensure all samples and reagents have been prepared, tested or inspected according to specifi-cations and current testing. •Leads training of new associates •Leads method revision and transfers •Authors method validation protocols and reports. Performs method revision and validation as well as assisting with method development •Leads optimization of test procedures to improve efficiency whenever possible. •Authors new and revises existing standard operating procedures to ensure compliance •Provides feedback (formal and informal) to team members on routine basis •Execute mid-year and year end performance appraisals for direct reports •Perform review and release of test work. •Other 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.
 Leadership experience and people management skills  Understands business needs and can provide strategic input  Work with biohazardous agents such as human cells, HIV Lentiviral Vector, Human AB serum.  Requires walking / standing for extended periods (up to 6 hours) throughout the work shift  May require dexterity for fine motor tasks such as pipetting and sterile manipulations in biosafety cabinets (periods up to 2 hours)  May need to adapt to changing work shifts, both swing and/or graveyard on very short notice  May use a computer for greater than 4 hours a day.
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 MS in biology, chemistry, biochemistry, microbiology or other related science, Advanced degree highly desirable. English  Minimum of 8 years' experience in the pharmaceutical/Biotechnology industries conducting QC testing, re-lease testing and coordinating the activities of a QC laboratory.  Previous people management experience  Knowledge of cGMP, USP and FDA guidelines.

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