Heather Siefers

Experience

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  BBI Biotech

  May 2000 - Sept 2002

  Research Associate I/Research Associate II: Clincal Trial Project Coordinator

  Assist in training the Costa Rica Repository Staff in fresh blood processing and frozen sample inventory and shipment at the Costa Rica Site Lab. Write procedures for vaccine handling, storage, labeling and shipping.Coordinate the receipt and shipment of vaccine to and from BBI Biotech. Acted as a liaison between the various contractors involved with the vaccine trial, including the National Cancer Institute, Glaxo Smith Klein and Westat. All daily laboratory fresh blood processing and cryopreservation. Show less

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  SeraCare BioServices (formerly BBI Biotech)

  Sept 2002 - Nov 2005

  Supervisor/Manager

  Coordinate daily lab operations for the National Cancer Institute repository and the SeraCare BioServices Global Repository in addition to supervising all associated repository research associates and data entry personnel. Communicate with government investigators and other collaborators in regard to specimen tracking and processing both internally and externally.Advise Investigators, Study managers and Study Sites on organization and status of samples, shipping procedures and date management of samples in inventory. Prepare reports and correspondence to government and government collaborators.Stay apprised of and participate in (as needed) all repository operations (fresh processing, frozen sample projects, data entry, etc.), and communicate and coordinate activities as appropriate. Approve incoming and outgoing samples to ensure accuracy.Assist Investigators and Study Managers in the implementations of new studies and protocols.Track incoming and outgoing sample shipments. Interview and hire repository personnel as needs arise. Show less

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  SeraCare BioServices

  Nov 2005 - Dec 2007

  Senior Manager

  Executed the full range of all Supervisor responsibilities while providing comprehensive scientific activities to integrate the needs of customers with those of the organization. Served as advisor to the Sr. Management Team regarding process improvement, operational management, talent management, training/change management, health & safety, organizational development, and business opportunity. Key Achievements:• Ensure quality control procedures are compliant with corporate and regulatory guidelines.• Maintain and support safe lab practices and environment.• Communicate with government investigators and other collaborators in regard to specimen tracking and processing both internally and externally.• Advise Investigators, Study Managers and Study Sites on organization and status of samples, shipping procedures and data management of sample inventory.• Prepare reports and correspondence to government and government collaborators.• Tracking of incoming and outgoing sample shipments and approve incoming and outgoing samples to ensure accuracy. Show less

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  SeraCare

  Dec 2007 - Mar 2012

  Provide tactical and strategic direction for bioservices operations managing both government and commercial contracts. Responsible for managing and coordinating all aspects of department operations. Provide day to day, hands-on knowledgeable leadership and coaching/counseling on development, policies & procedures, training & safety standards and client relations. Provide comprehensive pre-analytical biospecimen and data management for commercial projects and 3 large-scale NIH contracts for the NCI, NHLBI, and DAIDS totaling over 15 million samples including collection site assessment and management. Established and led inventory tracking programs and custody tracking systems. Show less Provide tactical and strategic direction for bioservices operations managing both government and commercial contracts. Responsible for managing and coordinating all aspects of department operations. Provide day to day, hands-on knowledgeable leadership and coaching/counseling on development, policies & procedures, training & safety standards and client relations. Provide comprehensive pre-analytical biospecimen and data management for commercial projects and 3 large-scale NIH contracts for the NCI, NHLBI, and DAIDS totaling over 15 million samples including collection site assessment and management. Established and led inventory tracking programs and custody tracking systems. Managed compliance issues across 3 locations spanning the DC Metro area and Massachusetts. Show less

  • Director, Repository Operations

    Apr 2010 - Mar 2012

  • Associate Director, Repository Operations

    Dec 2007 - Apr 2010
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  Aeras

  Mar 2012 - now

  Senior Manager, Clinical Biorepository Operations

  Provide oversight of the acquisition, tracking, transport and storage of biological specimens and ancillary supplies for active clinical trials and supportive preclinical/nonclinical studies. Analyze department operations to implement a continuous improvement environment promoting increased quality compliance, process efficiency and cost effectiveness. Expand upon existing pre-analytical biospecimen and data management for clinical/preclinical projects including collection site management. Establish and lead inventory tracking programs and custody tracking systems. Show less

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  IAVI

  Oct 2018 - now

  Provide oversight of the acquisition, tracking, transport and storage of biological specimens and ancillary supplies for active clinical trials and supportive preclinical/nonclinical studies. Analyze department operations to implement a continuous improvement environment promoting increased quality compliance, process efficiency and cost effectiveness.

  • Senior Manager, Clinical Biorepository Operations

    Oct 2018 - now

  • Senior Manager, Clinical Biorepository Operations at IAVI

    Oct 2018 - now