Team Leader/Principal Scientist IVD
Location: Fremont, California
Job Type: Full time
For over 20 years, Abcam has been providing tools the scientific community needs to enable faster breakthroughs in critical areas like cancer, neurological disorders, infectious diseases, and metabolic disorders.
We believe that to continue making progress, we need to work together in new ways. We need your own unique perspective as well as this of our people to make an always greater impact on the world. This community needs people like you: dedicated, agile and above all audacious so we can truly bring progress forward.
Working to ISO13485 and GMP-compliance and reporting to the Senior Director of Validation & Technical Quality, the Team Leader/Principal Scientist will manage a team of skilled scientists and technicians in the verification & validation of new and established products into our in vitro diagnostics portfolio of pathology biomarkers. This growing area of business within Abcam has with high visibility and also includes the engagement with industrial customers for GMP-manufacture of custom clones, as we focus on serving life scientists to achieve their mission, faster.
Your knowledge of V&V procedures for the delivery of IVD products in the pathology market will be exemplary. You will have great communication skills to interface regularly with key stakeholders around the business, including QA, Manufacturing and Business Development. In addition, as part of a global IHC team, you will be expected to interact with our IHC colleagues globally, in alternate US sites, UK and China as we align our IHC processes.
This role requires a deep understanding of immunohistochemistry (IHC) and IHC processes across a variety of staining systems within a regulated environment. You will be expected to have experience in tissue recognition and tissue scoring procedures to a high degree. You will, in addition, have experience of digital pathology and image analysis. The successful candidate will line manage a team of 5 scientists and technicians with potential to increase with future requirements. While not a lab-based role, occasional benchwork for training or troubleshooting may be required.
Based in Fremont, California, the role requires a minimum of 3x days per week on-site to maximize teamworking with key stakeholders and labs. It would involve routine interaction around the Abcam global network, including the occasional flexibility for off-hours calls on the East Coast of the US, UK and China.
- You are a leader and expert in immunohistochemistry within a regulated environment and have significant experience in generating immunohistochemical staining profiles in multiple tissue types to determine specificity and sensitivity of a given product.
- You have experience in working under ISO13485, utilising 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 organisation.
- 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.
- Experience in digital pathology and image analysis would be an advantage
- You will possess these broader professional skillsets
- A neutral, data-driven approach and an open-mind.
- The ability to manage multiple workflow streams (advanced time-management skills).
- Constructive mindset to merge Company goals with scientific transparency for customers.
- Overall confidence in being a leader, in running meeting agendas, organising multiple parties to work toward a common goal and other project management skills.
- Willingness to look beyond day-to-day tasks and collaborate with the larger organisation to attack broader issues impacting the wider Abcam business.
- A PhD in biology and post-doctoral experience in the field of pathology, or relevant experience.
- 3+years of industry (non-academic) experience within a regulated environment.
We know that when it comes to benefits, no one size fits all. Flexibility and choice matter which is why in addition to market competitive salaries, we offer you a flexible benefits package which is tailored to your unique needs and support your financial, physical and emotional wellbeing. This includes our award-winning share scheme, 18 weeks fully paid maternity leave, 6 weeks fully paid paternity leave as well as highly flexible working and much more. Besides, your development will be integral to your experience here. You will grow alongside other talented minds, in ways you may often find unexpected.
When people come together, incredible things happen. Here you’ll work in a safe environment where you can be who you truly are. We’ll champion and celebrate your uniqueness throughout your journey with us. This is how we excel at partnering with the scientific community no matter the challenge, ultimately helping solve the world’s most critical diseases. Find out more about Diversity & Inclusion at Abcam.
Effective January 1, 2022, all U.S.-based employees are required to be fully vaccinated against COVID as a condition of employment at Abcam. Employees with a sincerely held religious belief and/or disability impacting their ability to obtain the COVID vaccine can request a reasonable accommodation.