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(Senior) Scientist, Bioanalytical Science (R3438)
Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients.
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 (mouse studies, exploratory tox & Dose Range Finding) studies. As such, we provide a strong foundation for informed decision-making at critical points throughout our entire drug development program.
Your role at Genmab
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 binding ADA (bADA) methods. As such you lead the in-house development, qualification and execution of ligand binding assays, as well as the transfer to Contract Research Organizations (CROs) upon which you monitor assay validation and performance. In addition, you will work closely together with a team of technicians to coordinate, execute, and report the sample assessment of studies. To achieve this, you work in a regulated GLP/GCP environment, adhering to relevant guidelines and standard operating procedures to guarantee data reliability.
Responsibilities include but are not limited to:
Oversee development, qualification, execution and transfer of ligand binding assays to measure pharmacokinetic (PK) and anti-drug antibody (ADA) responses in biological matrices
Ensure compliance to GLP/GCP guidelines and carry out tasks according to standard operating procedures and study-specific plans
Ensure to be adequately trained according to the BioA training matrix
Communicate with Clinical Trial Manager during all stages of the study
Hold final responsibility for the scientific, administrative (including archiving) 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
What we ask
You have a finished PhD degree and 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.
Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural environment, with an aim to make a difference in the lives of people with cancer.
At Genmab, we pride ourselves on our unique culture. We are committed to make a positive impact on the lives of cancer patients. We hypothesize and experiment to seek innovative solutions, no matter the employee’s role; we speak up, empower each other, and embrace change and growth; we respect and celebrate our differences while working as one team. Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. Genmab employees work with determination, challenge the status quo and cultivate a growth mindset in everything we do.
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability or genetic information.
Please note that if you are applying for a position in the Netherlands; Genmab’s policy for all permanently budgeted hires in this location is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
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.