Merck & Co.-posted 9 months ago
Full-time
Onsite • West Point, PA
Chemical Manufacturing

The PDMB Regulated Bioanalytics Department is seeking a Data Management Associate to join our LIMS & Data Management group. This role will support work across groups within the Regulated Bioanalytics Department, including work at our company's new state-of-the-art AdVAnce GxP research facility in West Point, PA. At this new facility, we will combine the power of innovative robotics, IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high-quality regulated bioanalytical data. A combination of molecular (e.g., PCR), serology (e.g., ligand binding immunoassays), and cell-based assays (e.g., neutralization assays) will be utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility will not be fully constructed and ready for occupancy until 2026, initial roles will complete training and perform work primarily at our company's Springhouse Innovation Park facility in Lower Gwynedd Township, PA. An ideal candidate will have experience managing and implementing Laboratory Information Management Systems (LIMS) within the regulated bioanalytical laboratory setting.

  • Participate in the development, testing, validation, and implementation of LIMS systems or related upgrades to meet the needs of various bioanalytical singleplex and multiplex assays, including the authoring of related documents.
  • Collaborate across a diverse group of stakeholders and partners to understand the end-to-end sample tracking, data analysis, data archival, and data submission needs for internal and external laboratories and develop appropriate solutions.
  • Perform day-to-day LIMS activities for method qualification/validation and clinical study support including, but not limited to, user training, troubleshooting, study setup, sample reconciliation, and management of clinical data transfers in line with regulatory data standards.
  • Identify and implement new capabilities that support data handling or data integration into bioanalytical or downstream systems (e.g., electronic lab notebooks, LIMS, clinical databases).
  • Execute computer system validations associated with laboratory computerized systems and equipment.
  • Experience utilizing or implementing custom or commercial Laboratory Information Management Systems (LIMS).
  • Experience working with multiplex and singleplex bioanalytical assays, used for the support of vaccines or drug programs in development (e.g. immunogenicity, cell-based assays, PK, PCR serotyping).
  • Ability to quickly analyze and interpret complex processes and problems and propose creative solutions.
  • Direct experience participating in computer system validations.
  • Strong collaborator, possessing strong verbal and written communication skills.
  • Capable of working independently, with limited supervision, under project timelines.
  • Experience working specifically with vaccines bioanalytical assays, primarily those involved with immunogenicity or molecular based assessments.
  • Experience operating in a regulated bioanalytical laboratory.
  • Experience driving improvements for regulated bioanalytical data workflows either directly within a LIMS system or through other applications (e.g., Microsoft Excel).
  • Working knowledge of data standards (e.g. CDISC) and applicability to bioanalytical data.
© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service