Biosample Sample Associate
Nektar Therapeutics
Hyderabad, India, United States
3d ago

Position Overview

The Biosample Sample Associate will be responsible for sample management for the Bioanalytical department.

Position Summary :

The role involves management of samples and references analytical standards to support bioanalytical activities required as per established SOPs and protocols.

The incumbent must demonstrate proven record of hands on experience in ensuring safe custody, control and management of biological samples and reference standards in freezers, refrigerators and similar storage facilities.

Is familiar with chain of custody of biological samples from receiving to disposal stage. Knowledge of operation, calibration and maintenance of -80 deg C deep freezers, -20 deg C Freezers, 2-8 deg C refrigerators is essential.

Has ability to handle the sample documentation. Is familiar with 24 7 temperature monitoring systems. Has ability to ensure safe custody of samples.

Has knowledge to set up simplified processes to track samples via paper and electronic systems like Laboratory Information Management systems (LIMS) and barcoding labeling system.

Maintains up to date knowledge of bioanalytical guidelines, Global Bioanalysis Consortium (GBC), current industry practices related to management of biological sample, reference standard and reagents.

Executes the activities as per written procedures and in a timely manner and record all activities to ensure traceability.

Updates Manager / Supervisor routinely on the outcome of results and reports failures and deviations without any delay. Knowledge of instruments like HPLC, LCMS, ELISA, MSD and sample preparation techniques used in a bioanalytical set up are desirable.

  • Sample accountability : Completely responsible for all types of samples received for storage from date of receipt to date of disposal.
  • Sample Receiving : Check the integrity of samples with respect to sample documents, storage conditions, transit conditions, temperature data, sample integrity, labeling, sample numbers, sample volume, and container integrity.
  • Report discrepancies with respect to documentation, labeling or container immediately to the supervisor.

  • Sample storage : Store the samples as per recommended temperature. Ensure storage location and appropriate space and storage conditions are reserved in advance to receive samples.
  • Chain of custody : Issue the samples to analysts for analysis and retrieve the unused samples for re-storage. Maintain sample movement records within and outside the lab.
  • SOP and trainings : Understand SOPs and procedures.
  • Commitment to Quality : Ensure activities conducted in the bioanalytical lab complies with established SOPs, procedures, systems, regulatory guidance without deviating from established procedures.
  • Calibration / maintenance of storage equipment : Ensure all equipment are maintained at desired temperatures 24x7. Ensure all calibrations and maintenance activities are completed as per SOPs.
  • Document management : Ensure safe custody of documents. Other duties as assigned by Supervisor.
  • Educational Requirement : Bachelors in Science with 0-5 years of experience or M.Sc. / M. Pharm with 0-2 years of experience.

    Knowledge of Good Laboratory Practices (GLP) procedures and bioanalysis related guidance documents on OECD and USFDA, EMA.

    Familiarization with computer is essential (MS word, MS Excel, Power point). Must be willing to work as part of a team and should have good Well versed with good interpersonal skills, presentation and communication skill.

    Handling of electronic software for sample management will be considered an added advantage

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