Data Management Associate, Regulated Bioanalytics, Regulated Robotics & Data, LIMS & Data Management

Job Description

Job Description 

Data Management Associate (R2), Regulated Bioanalytics, Regulated Robotics & Data, LIMS & Data Management 

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.  Key responsibilities will include the development, validation, and enhancement of LIMS systems or related modules that are used to track sample chain of custody records, analyze bioanalytical data, and handle data management.  The candidate will also provide operational support of bioanalytical sample and data flow processes as well as the validation of computerized systems.  Much of the role will involve data from vaccine assays and systems, where experience is preferred, but will also include other modalities and methods supported by the bioanalytical labs at our company or external partners.  

Education Minimum Requirement 

B.A./B.S. Degree in Biology, Chemistry (or related sciences), or Information Technology with at least 3 years of industry experience or an M.S. Degree in the same areas 

Responsibilities 

• 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 com