Histology & Tissue Imaging Core Manager

JOB PURPOSE

The Histology & Tissue Imaging Core Manager is responsible for the oversight, of the Histology Core facility in Cambridge. The manager will oversee the Histology CORE and support Programs across SANA using both traditional and state-of-the-art histological techniques under the direction of the Head of Pathology. As a Manager of a Core Histology Facility, the candidate is expected to have hands-on experience in basic histological practices including but not limited to tissue processing, sectioning, and routine staining (e.g. H&E) procedures. In addition to routine histological techniques, the candidate is expected to have good understanding of the histo-lab environment (day to day operations, equipment maintenance, troubleshooting) in order to run the lab effectively. The manager provides operational and scientific management and reporting for the Histology Core as well as contracted exploratory Toxicology/Biodistribution of drug candidates in the department of Development Sciences. This person will work closely liaising between the internal Project Team leads and ED of Pathology to effectively develop, manage, and track all aspects of assigned histology endpoints for in vivo non-clinical studies and assist investigators with tissue collection procedures for critical histology endpoints. The manager may be expected to supervise and train junior scientists to support the Histology Core.

DUTIES AND RESPONSIBILITIES

• Provide histology expertise to facilitate target identification/validation, animal model development, biomarker discovery/development, investigation of toxicities, and pharmacology discovery research as needed by Project Teams under the direction of the Head of Pathology
• Report histological endpoints and interpretations to the Head of Pathology for approval prior to sharing with Project Teams
• The manager will have oversight of the lab and provide scientific input for histology endpoints for preclinical exploratory discovery and early toxicology studies
• Assist in identifying, evaluating, and implementing new technologies or techniques in our in-house histology laboratories across Sana and serving as the CORE expert to support and interact with other Sana R&D sites across the country with protocols or services as needed
• The histology manager is expected to devise the best strategy (in-house vs outsourcing) when there is a request for expedited turnaround of histology data from Project Leads.
• As the CORE manager you will be responsible for supporting requests from other sites to help with finding equipment, resources, methods or external CROs to support investigator needs
• The manager will provide training and assistance for terminal necropsies and be knowledgeable in study specific needs for tissue collections i.e. aseptic for tissue culture, DNA/RNA-free for PCR, fixation immersion for general histopathology, and or perfusion methods for specialized immunohistochemistry
• Be proficient in tissue imaging techniques and introduce/build new tissue imaging modalities (eg. basic slide scanning to quantitative image analysis tools)
• Effectively develop, manage, and track all aspects of assigned histology endpoints for exploratory in vivo non-clinical studies
• Present histology data and interpretations in written and oral form
• Contribute to tactical resolutions to challenges and troubleshooting (e.g. study design optimization to get tissue samples needed, outsourcing for expanded bandwidth, etc)
• Coordinate shipment of samples and reagents between sites and contract laboratories to facilitate histology endpoints on studies SANA-wide
• Arrange for archival of study data, reports and materials at study finalization, participate in QA audits as needed
• Work with Legal and Non-clinical Operations manager to ensure CDA/NDA, MSA, SOW, and POs are in place and tracked properly

QUALIFICATIONS

Basic Qualifications

• Bachelors with 3-6 years of industry experience or HT or HTL certification with 10 years of histology lab experience preferably in a pharmaceutical industry
• The candidate is expected to have good understanding of the histology lab environment (day to day operations, equipment maintenance, troubleshooting) in order to run the lab effectively
• Understanding of and experience with basic and advanced tissue-based investigative techniquesfor example: routine histological stains, immunohistochemistry, in situ hybridization, immunofluorescence, digital image analysis, electron or confocal microscopy, laser capture microdissection, etc.
• Strong skill set in developing and implementing multiplexed immunohistochemistry methodologies from antibody selection, staining optimization,
• Tissue imaging experience from pre-analytical variables assessment to downstream digital and imaging strategies with data evaluation capabilities as it applies to transmitted light versus fluorescent versus confocal microscopy
• Understands basic in vivo study design principles
• Must be detailed oriented, with ability to multi-task and work cross-functionally with team members and team environments
• Effective communicator both verbally and in writing
• Excellent interpersonal, organizational and problem-solving skills required to manage multiple studies at different phases in parallel and track work and projects to meet timeline demands
• Must be proficient with MS Office (Word, Excel, PowerPoint etc) and basic statistical packages (eg. GraphPad Prism or similar)

Preferred Qualifications

• Bachelors or Masters 2-4+ years with HT or HTL certification and 5 years of pharmaceutical industry experience; ALAT, LAT or LATG certification a plus
• Familiarity with working with image analysis software e.g. Imaris, MetaMorph, Image J, LAS, or HALO
• Knowledge of the design and conduct of non-clinical exploratory toxicology safety studies for the development of large molecules or cell or gene therapies
• Familiarity working with either internal or external study sites and Study Directors
• Experience working with Pathology partner lines both internal and external to support data generation and analyses for sub-reports
• Familiarity working with contracts and or legal to put study agreements in place
• Familiarity with Provantis and or Xybion or similar data management software a plus
• Familiarity with SEND file generation and interfacing with a Biostatistician to assist as needed in the preparation of robust pathology data sets for regulatory submissions