Clinical Samples Manager

Gaithersburg, MD
May 19, 2017
May 29, 2017
Full Time
Are you ready to work for one of Washington's Top Workplaces? At Novavax, a clinical-stage vaccine company, we are creating tomorrow's vaccines today! We seek to attract, develop, and retain talented people who share our passion for science, medicine, and human health. We foster an environment of teamwork and collaboration, built on a culture that values and appreciates its employees. We are a fast-paced company that provides employees with opportunities to achieve personal and professional goals while also maintaining a balance between work and personal life. We are currently looking for a Clinical Samples Manager to join the Clinical Immunology team located in Gaithersburg, MD. This is an opportunity to join a fast paced, dynamic group! Responsibilities include but not limited to: Sample Management Team:Manage operations of clinical sample receipt laboratory team according to Novavax's clinical quality systemManage the team to receive, handle, and inventory specimens of human or animal origin at temperatures ranging from ambient to -196C.Review sample receipt document for accuracy.Ensure Clinical Sample team follows Novavax SOPs, safety guidelines and FDA requirements.Review and draft sample management related SOPs.Direct sample team to coordinate e-manifest receipt and upload into LIMS.Work cross-functionally with Clinical Operations and maintains an updated schedule for sample receiving and testing timelines. Attend inter department meetings as needed.Lead team to log incoming samples and manage sample life cycle while maintaining chain of custody throughout.Point of contact for audit findings related to sample chain of custody or repository issues.Responsible for sample volume, sample aliquoting as well as supply of samples to testing laboratories.Coordinate and manage sample shipments.Coordinate with outsourced vendor budget as well as process flow and data exchange with external biorepository including managing contracts and POs for long-term sample storage and receipt.Support internal and external customer inquiries, sample discrepancies, inventory maintenance and database updates.Assist in implementing inventory management system for data entry, sample tracking, and overall management of samples in current or new LIMS systemParticipates in quality process improvement activities.Interacts with other department teams to deliver samples for CI testing in a timely manner Lab Support: Oversight of lab support to ensure operation & maintenance of clinical testing equipment, including but not limited to:Calibrations/Verifications are kept up to dateDaily equipment verifications as neededWeekly equipment/laboratory maintenance as neededMonthly equipment/laboratory maintenance as neededEnsure all equipment is qualified before put into GCLP useOversight of lab support to ensure general inventory is maintained.Ensures all orders are made in a timely manner.Ensure the lab support team maintains all common use consumables as needed for clinical testing to progress without delays. Ensure the lab support team maintains all common use reagents as needed for clinical testing to progress without delaysEnsure that lab support receives all materials into Clinical Immunology in a compliant mannerProvide feedback to other Clinical Immunology teams for potential cost saving opportunities and explore as possible without negative impact to testing timelines.Oversight of lab support to ensure general use formulations/buffers are prepared according to Clinical Immunology's SOPs. Minimum Requirements: Masters or Bachelor's degree in biological science, molecular biology, immunology, or equivalent years of relevant industry experience.At least 5-7 years hands on Industry experience or collaboration with Industry with LIMS and Sample ManagementPrevious experience with high throughput laboratoryFamiliarity with MS Word, Excel, EDMS, SoftmaxPro GxP and LIMS.Flexible in time management & proven ability to lead a team.Self-starter who can work independently and a team player who can work cross functionally. Attention to detail is desirable. Novavax, Inc. is a clinical-stage vaccine company committed to delivering novel products to prevent a broad range of infectious diseases. Our recombinant nanoparticles and Matrix-M adjuvant technology are the foundation for groundbreaking innovation that improves global health through safe and effective vaccines. Our product pipeline targets a variety of infectious diseases with vaccine candidates currently in clinical development for respiratory syncytial virus ("RSV"), seasonal influenza, pandemic influenza, and Ebola virus ("EBOV"). We have additional preclinical-stage programs for a variety of infectious diseases. Novavax is headquartered in Gaithersburg, Maryland with additional facilities in Rockville, Maryland and Uppsala, Sweden. Novavax, Inc. offers a base salary, annual bonus, stock options, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan. We are an equal opportunity employer that values diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply.0Job Posted by ApplicantPro

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