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Senior Scientist, Clinical Bioanalytical Science (R7064)
At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.
(Senior) Scientist, Clinical Bioanalytical Science
The Bioanalytical Science team is responsible for developing fit-for-purpose bioanalytical strategies to quantify drug in circulation and assess unwanted immunogenicity for Genmab’s compounds. We are experts in the design, development, validation, execution and interpretation of bioanalytical methods, with a focus on pharmacokinetics/pharmacodynamics (PK/PD), anti-drug antibodies (ADA), and neutralizing antibodies (NAb). We perform bioanalysis activities for both regulated (GLP, GCP) and non-regulated exploratory studies. As such, we provide a strong foundation for informed decision-making at critical points throughout our entire drug development program.
As a (Senior) Scientist within the Bioanalytical Science team, you act as Scientific Lead for Genmab compounds in the clinical development stage. You will be part of the cross-organization development teams for several programs and be responsible for the bioanalytical method strategy, mainly focusing on PK and ADA methods. As such you lead the in-house development, qualification or validation, and execution of ligand binding and NAb assays, as well as the transfer to Contract Research Organizations (CROs). In addition, you will work closely together with a team of technicians to coordinate, execute, and report on sample analysis. To achieve this, you work in a regulated GLP/GCP environment, adhering to relevant guidelines and standard operating procedures aimed at ensuring data reliability.
- Oversee development, qualification, validation, execution and/or transfer of ligand binding and NAb assays to measure pharmacokinetic (PK) and anti-drug antibody (ADA) responses in biological matrices
- Ensure compliance to GLP/GCP guidelines, develop study-specific plans and carry out tasks according to standard operating procedures
- Ensure to be adequately trained according to the BioA training matrix
- Participate in multi-disciplinary project teams and communicate with Clinical Trial Manager during all stages of the study
- Hold final responsibility for the scientific, administrative (including authoring and archiving of necessary documentation) and regulatory aspects of the bioanalytical part of a clinical trial
- Act as a primary contact for external parties (validation, managing timelines, troubleshooting, analysis)
- Support technology innovation and/or process improvement projects
- Keep the department up to date with the latest relevant scientific information regarding immunology, bioanalysis and additional regulatory documents
- You have a finished PhD degree and at least 2 years of relevant experience in bioanalytical method development and validation, or a MSc degree with 5 years relevant experience in bioanalytical method development and validation
- You have a proven track record in the development and troubleshooting of immunological and bioanalytical assays
- You have experience in method development to evaluate unwanted immunogenicity
- You have demonstrated experience with regulatory bioanalysis and knowledge of relevant guidance documents
- You are flexible, well-organized and can lead several projects at once, and you are able to work to tight deadlines
- You have experience in managing contract research organizations;
- You have excellent relational and communication skills in English;
- You are eligible to work in the Netherlands without the requirement of applying for a permit
- You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
- You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
- You are a generous collaborator who can work in teams with diverse backgrounds
- You are determined to do and be your best and take pride in enabling the best work of others on the team
- You are not afraid to grapple with the unknown and be innovative
- You have experience working in a fast-growing, dynamic company (or a strong desire to)
- You work hard and are not afraid to have a little fun while you do so
Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.
Genmab is an international biotechnology company with a core purpose to improve the lives of people with cancer. For more than 20 years, Genmab’s vision to transform cancer treatment has driven its passionate, innovative and collaborative teams to invent next-generation antibody technology platforms and leverage translational research and data sciences, fueling multiple differentiated cancer treatments that make an impact on people’s lives. To develop and deliver novel therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. Genmab’s proprietary pipeline includes bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates.
Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. For more information, please visit Genmab.com and follow us on Twitter.com/Genmab.