Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients.
As a Histopathology Laboratory manager in our US Pathology team based in Princeton, New Jersey, you will help oversee the workflow of a clinical IHC laboratory focusing on biomarker development for clinical trials. You will manage a team with expertise in histology, immunohistochemistry, in situ hybridization and multiplex immunofluorescence techniques and be responsible for workflow strategies to ensure timely delivery of high-quality biomarker data to support our pipeline. You will be an essential link between pathologists, lab scientists, digital pathology scientists, translational research leads, biomarker operations and lab management personnel located both in the US and in the Netherlands.
Manage our US histopathology laboratory overseeing clinical trial biomarker work including tissue sectioning, chromogenic IHC, ISH, multiplex IHC and IF, slide scanning and digital pathology workflows.
Provide guidance on experimental design and manage a team tasked with developing complex tissue-based assays to address mechanism of action and pharmacodynamic of our drugs.
Support generation of appropriate Standard Operating Procedures (SOPs) and Job Instructions (JIs) for laboratory equipment.
Work closely with Environmental Health and Safety (EHS) and the training department to ensure that all safety measures are in place and that the laboratory personnel Training Dossier is up to date.
Collaborate with our Netherlands pathology team, and across departments to support discovery, translational research, data sciences and clinical efforts.
Work closely with laboratory operations personnel both in the US and the NL to ensure best practices across both sites, and to establish standardized workflows to process clinical samples for a variety of tests including in house genomics.
Help define and implement streamlined operational workflows to ensure equipment maintenance, inventory, purchases, shipment and receiving of samples, and scheduling of work packages are done efficiently. Supporting functions are in place to assist with these tasks.
Work closely with clinical biomarker operations, translational leads and clinical development leads to ensure timely delivery of pathology data for our clinical programs.
Supervise the maintenance of our tissue repository of blocks and slides from commercial sources and clinical trial patients through LIMS. Patient samples from trials should be handled in accordance with trial protocols, informed consent forms and GxP workflows.
Work closely with our digital pathology, data sciences and IT teams to ensure our images are catalogued and stored correctly and are compliant with GXP practices and IT security standards.
Ensure proper usage of our LIMS and ELN systems and record keeping for all activities performed in the laboratory.
Formal education in the biomedical field with a minimum of a bachelor’s degree. Certification in histotechnology or immunohistochemistry desirable.
A minimum of 8 years of professional laboratory experience after graduation/certification. A minimum of 5 years of direct experience in histopathology laboratory management focusing on clinical IHC workflows.
Team management experience required.
Preference for professionals with commercial laboratory management experience. Industry experience desired but not required.
Expertise in design, trouble shooting and validation of immunohistochemistry biomarker assays for clinical studies.
Familiarity with GXP laboratory information systems (LIMS) and CAP/CLIA standards and certification highly desirable.
Excellent written and verbal communication skills and experience with the Microsoft suite of products (Teams, Excel, word, PowerPoint, MS project).
Working knowledge of statistical and data visualization software (SAS, GraphPad, Spotfire) and of image analysis software desirable.
Positive and open mindset to establish and maintain collaborations across different department and geographies of the company, as well as with external investigators as needed.
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer.
Founded in 1999, the company is the creator of four approved antibodies. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab's technology base consists of validated and proprietary next generation antibody technologies and intends to leverage these technologies to create opportunities for full or co-ownership of future products.
Genmab has alliances with top tier pharmaceutical and biotechnology companies. Genmab is headquartered in Copenhagen, Denmark with sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.