IVD Team Lead

Abcam is a leading company dedicated to serving life scientists and supporting their mission to advance scientific discovery. With a commitment to ISO13485 and GMP-compliance, Abcam focuses on delivering high-quality in vitro diagnostic (IVD) products, particularly in the field of pathology biomarkers. As a global organization, Abcam collaborates with industrial customers for GMP-manufacture of custom clones, contributing to the growth and visibility of this crucial business segment.

Position Overview:

Reporting to the VP of Validation & Technical Quality, the Team Leader/Principal Scientist will play a pivotal role in managing a team of skilled scientists and technicians. This team is responsible for the verification and validation of new and established products within Abcam's IVD portfolio, emphasizing pathology biomarkers. The role involves close collaboration with key stakeholders, including QA, Manufacturing, and Business Development, to ensure compliance and excellence in product delivery.

Key Responsibilities:

• Lead and manage a team of scientists and technicians, with potential for expansion based on future requirements.
• Oversee the verification and validation processes for IVD products, focusing on pathology biomarkers.
• Utilize deep knowledge of immunohistochemistry (IHC) and IHC processes in a regulated environment.
• Engage with industrial customers for GMP-manufacture of custom clones, contributing to business growth.
• Regularly interface with global IHC colleagues in the US, UK, and China, aligning IHC processes.
• Demonstrate expertise in tissue recognition, tissue scoring procedures, digital pathology, and image analysis.
• Occasionally perform benchwork for training or troubleshooting purposes.

Requirements

You have a PhD in biology and post-doctoral experience in the field of pathology or relevant experience with at least 3 years of industry (non-academic) experience within a regulated environment. You are a leader and expert in immunohistochemistry within a regulated environment and have significant experience in generating immunohistochemically staining profiles in multiple tissue types to determine specificity and sensitivity of a given product. You have experience in working under ISO13485, utilizing CAPA, FMEA and Quality Plans to improve working processes.

You possess the ability to train the next generation of technicians and scientists in your team and have a proven track record in managing and building a team in a growth environment. You can demonstrate, through the creation and delivery of KPI’s, that you can deliver IVD products to expected timelines. You have advanced communication skills to interact with local and global stakeholders.

You are comfortable working in a fast-paced, growing organization. You are experienced in generating high quality, scientific presentations for high-value industrial collaborations. You understand the importance of ethical compliance for human biological samples.