Associate Director, Regulated Robotics, Liquid Handlers

Job Description

The Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) Regulated Bioanalytics Department is seeking an Associate Director for the Liquid Handlers team to join our Regulated Robotics 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.  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 design, transfer, and develop various preclinical and clinical assays for our vaccines pipeline on robotic systems in a regulated environment.  The individual will be responsible to lead assay to automation transfers, qualification/validation, technology transfer, and/or troubleshooting.  Importantly, the successful candidate will have a proven track record to develop, optimize, and execute various biological and chemical assays on various automation platforms.  The candidate should be current on state-of-the art technologies and champion the evaluation of new technologies and optimization of processes.  Providing leadership and mentorship to junior staff, building relationships with stakeholders, and providing expert technical representation on multidisciplinary teams will be expected. The candidate should have in-depth quality and compliance knowledge that aligns with current procedures, guidance's, and regulations and have deep expertise applying these concepts while overseeing the end-to-end bioanalytical phase of testing. 

Education Minimum Requirement

• BA/BS with 10 years of experience, MA/MS with 6 years of experience, or PhD with 4 years.  Degrees in Engineering, Automated Sciences, Computer Science, Biology, Chemistry or equivalent with scientific expertise with laboratory equipment in the development and execution of biological and chemical assays

Responsibilities

• Design and oversee operations of robotic systems to validate, optimize, and execute new vaccine program clinical assays on various automation platforms in a regulated environment 

• Inform method development, qualification/validation, troubleshooting and/or assay format selection based on risk assessment and fit-for-purpose considerations

• Serve as an internal subject matter expert on developed assays, providing technical support as needed to internal and external laboratories working to implement assays

• Ensure assays are developed and executed in compliance with applicable guidance and regulations (e.g., GxP)

• Contribute to assay protocol and qualification/validation report preparation; address QA findings and observations

• Contribute to regulatory filings pertaining to assay details as needed  

• Communicate results effectively in presentations to stakeholders in partner organizations or at external scientific meetings, to write technical reports, and to participate on cross-functional teams 

• Adhere to basic safety procedures in a BSL2 laboratory and compliance to regulations

• Provide scientific oversight for robotic platforms assays being implemented internally and externally, including review of trending data and technical reports. 

 Required Experience & Skills

• Experience with laboratory automation schedulers such as Cellario, Green Button Go, or Momentum 

• Familiarity with liquid handlers and other automation platforms for sample preparation and assay process 

• Experience with various assays formats, including but not limited to immunology assays such as ELISA, AlphaLISA, multiplexed ligand binding assays (LBA) on the company's and/or Luminex platforms or in vitro primary immune cell functional assays such as ELISpot or multi-color flow cytometry

• Ability to lead, mentor, and inspire engineers and scientists at various levels; encourages curiosity in others and challenges the status quo to foster innovation

• Well-developed decision-making skills that thinks broadly across development programs 

• Familiarity with Regulated Bioanalysis and Good Laboratory Practice (GLP) is strongly desired

• Ability to independently analyze and interpret experimental data and to present and discuss results within a multi-disciplinary