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Senior Manager/Director, Biopharma Histology and IHC Laboratory R&D

Memphis, TN

PathAI's mission is to improve patient outcomes with AI-powered pathology. Our platform promises substantial improvements to the accuracy of diagnosis and the efficacy of treatment of diseases like cancer, leveraging modern approaches in machine learning. Rigorous science and careful analysis are critical to the success of everything we aspire to do. Our team, comprised of diverse employees with a wide range of backgrounds and experiences, is passionate about solving challenging problems and making a huge impact

The role:

Support the establishment of a quality and compliance centric histology/IHC lab to support biopharma partners. Draw on deep subject matter expertise in pathology based technologies to help inform the over- all biopharma laboratory strategy, including routine and novel assays as well as advanced staining and imaging platforms. Use empirical data generated in the PathAI laboratory (ie, PoC, head-to-head comparisons, etc) to inform platform strategies.  Oversee histology/IHC-based assay development and execution of deployed/validated assays for exploratory analysis. Contribute to development of assays for prospective/regulatory clinical trials. 

Requirements:

  • PHD or advanced degree in biomedical research
  • Direct experience developing routine and novel IHC-based  assays within Pharmaceutical Clinical Biomarker laboratories or CRO/reference laboratories or academic laboratories supporting Pharmaceutical biomarker programs  
  • Deep first hand understanding of the BioPharma needs as it relates to clinical biomarker data generations from outsourced services. 
  • Recognized subject matter expert in pathology/IHC assay development, scientific background,  QC and assay troubleshooting.
  • Deep understanding of lab quality frameworks applicable for global clinical trials.
  • Experience establishing relationships across the supply chain for assay development (ie, antibody generation, equipment manufacturers, etc). 
  • Direct people and laboratory management experience
  • History of publications in field of IHC, ISH, mIHC, mIF assay development 
  • Direct experience developing companion diagnostics for IHC assays is preferred.
  • Experience working on IHC CDx quality harmonization efforts will be preferred.

*This role is based in Memphis, TN.

What You'll Do: 

  • Set validation protocols and report structures for all pathology based platforms including routine histology and IHC and advanced multiplexing platforms. Lead scientists with tissue based biomarker capabilities.
  • Interface with technical counterparts in biopharma to establish robust requirements and validation strategies. 
  • Assist internal Business Development and Analytics teams on assay workflows and data related queries to ensure high quality deliverables to biopharma partners.
  • Highly detail oriented and ensures the timely and high quality delivery of partner projects through developing a culture of efficient tracking, updates and regular communication.
  • Establish assay component sourcing/procurement strategies and relationships 
  • Be responsible for the quality of translational research and new assay development and validation activities for tissue-based assays for biopharma partners.
  • Ensure study conduct per protocol requirements and in alignment with biopharma partner. Develop framework for communication and best practices to document and changes to the protocol or process. 
  • Stay current in all pathology based platforms and emerging technologies 
  • Establish best-in-class high quality assays to meet the needs of pharma 
  • Establish assay transfer strategies to the development team within PathAI laboratories or diagnostic companies for IVD development 
  • Provide oversight for new assay development and validation for  co-development programs for internal CDx development programs. 
  • Establish R&D efforts that will translate to novel high quality assays offerings to our biopharma partners 
  • Hire and manage direct reports and/or oversee shared resources towards histology/IHC wet lab operations for translational development and R&D team.
  • Establish and execute on capital equipment strategies 
  • Establish laboratory equipment procurement processes, SOPs, lab maintenance contracts, etc

Most importantly, you'll be doing important work with a team of people you'll enjoy spending the day with.

PathAI is an equal opportunity employer, dedicated to creating a workplace that is free of harassment and discrimination. We base our employment decisions on business needs, job requirements, and qualifications — that's all. We do not discriminate based on race, gender, religion, health, personal beliefs, age, family or parental status, or any other status. We don't tolerate any kind of discrimination or bias, and we are looking for teammates who feel the same way.