Director, Pharmacokinetics; Regulated Bioanalytics, Exploratory Vaccines & Regulated Robotics, LIMS & Data Management

Job Description

Job Description 

Director (M3), Regulated Bioanalytics, Exploratory Vaccines & Regulated Robotics, LIMS & Data Management 

The PDMB Regulated Bioanalytics Department is seeking a Director to lead the Laboratory Information Management Systems (LIMS) & Data Management team within the Regulated Robotics & Data 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. 

The primary role of the successful candidate will be to set the strategic direction and implement LIMS and other data management tools within the regulated bioanalytical laboratory setting.  The position is accountable for the team delivering development, validation, enhancement, and oversight of LIMS systems or related modules that are used to track sample chain of custody records, analyze bioanalytical data, and handle data management.  This team will also develop and implement tools to increase the efficiency of processes, data review, and data visualization that can be applied to increase the throughput of our Vaccines pipeline.  

In this role, responsibilities include coaching and mentoring across the organization, being influential in program strategy cross-functionally across our company's portfolio and working across industry teams and with health authorities to develop bioanalytical guidance.  The incumbent will be responsible for the recruiting and development of talent under her/his supervision. 

Education Minimum Requirement 

B.A./B.S. in Biology, Chemistry, Biochemistry, Engineering, Data Sciences, Computer Science or a related discipline with at least 15 years, M.S. with at least 10 years, or Ph.D. with at least 8 years of related experience 

Responsibilities 

• Provides leadership to individual contributors on LIMS & Data Management team 

• Represents LIMS & Data Management in early/late vaccine development teams and influences data strategies together with stakeholders 

• Provides oversight of development, testing, validation, and implementation of LIMS systems or related upgrades to meet the needs of various bioanalytical assays 

• Provides oversight of strategy, development, and valida