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Senior Scientist
Ref No.: 20-00200
Category: Biotechnology
Location: Pearl River, New York

We are seeking an experienced, dynamic and highly creative Senior Scientist to join the clinical testing assay team. The incumbent will report directly to the Head of Clinical Immune Assays and be responsible is to transfer the pre-clinical assays to phase I to III compliant robotic assays. Additional tasks include but not limited to supervise all sample management functions which includes sample/shipment acceptability, reconciliation and resolutions. Knowledgeable of key sample management and reporting data process/tools such as LIMS and etc. Ensure all laboratory procedures are conducted in clinical compliance with GCLP/GLP.

Responsibilities:
  • Work with Head of Clinical Immune Assay to organize and manage the development and qualification/validation of immunoassays to support immunogenicity assessments of vaccine programs.
  • Maintain oversight and track all clinical trial study samples operational activities including planning, from sample receipt to result reporting to investigator sites and/or external collaborators (and sample return, if applicable).
  • Expand internal capabilities, including automation, specimen management, and databases such as LIMS/eVent and etc, as needed, through in-house collaborations or external expertise to enhance infrastructure and processes.
  • Review and provide input to clinical study protocol for sample collection requirements and alignment with the study plans and company policies.
  • Oversee clinical trial supplies related to biospecimen collection, processing, shipment, and storage as, well as maintenance of associated tracking information.
  • Manage several projects at any given time, work successfully in a cross-functional team environment and communicate clearly both verbally and in writing to a variety of audiences.
  • Ensure that the Clinical Assay group's activities are performed safely; and regulated tasks/activities are performed in compliance with GCLP/GLP following a phase appropriate, incremental approach, from pre-clinical testing through to testing supporting licensed products, and Regulatory agency requirements.

Qualifications:
  • A working understanding of assay qualification and validation, as well as biostatistics, as it applies to immunoassays, is required.
  • Experience in oversight of immunoassay clinical sample analysis and delivery of results to Clinical Research.
  • Be dedicated to the highest standards of quality and adhere to all safety, regulatory, and quality requirements.
  • Expertise in working within a GCLP/GLP laboratory.
  • Must obtain a working knowledge of regulatory/quality requirements and perform within all Standard Operating Procedures (SOPs) and policies.
  • Well organized, focused on results, capable of managing multiple projects, excellent time management skills with respect to priorities and self-management.