Senior Scientist – Preclinical Release (Bioassays)

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.

The Role

We are seeking a Senior Scientist, Preclinical Release to join our Functional Characterization & Bioassays (FCB) department, which is part of CMC Science and Technologies. FCB plays a crucial role in ensuring the quality and characterization of Genmab’s antibody products by developing bioassays for release and stability testing.

As Senior Scientist, you lead a team of research associates and scientists dedicated to developing and validating (bio)assays for release and stability testing of antibody products. You will focus on designing and developing binding and potency assays (following ICH guidelines) for selected clinical candidates in the preclinical development and facilitating the transfer of these methods to GMP-testing facilities, including Genmab’s QC testing lab in Copenhagen. The team primarily develops non-cell-based methods such as enzyme-linked immunosorbent assays (ELISAs) and surface plasmon resonance (SPR)-based methods.

You recognize yourself as an empathetic people manager who cares for the wellbeing and personal development of your team members. With your solid bioassay knowledge and excellent communication skills, you represent the CMC bioassay expertise to stakeholders within and outside our organization (CRO's). In addition, you have affinity for improving processes to aid efficient transfer of the antibody products to the clinical phase. The position will report to the Director of Functional Characterization and Bioassays.

Responsibilities

• Lead and mentor a team of scientists and research associates, fostering a collaborative and high-performing environment.

• Plan, oversee, and prioritize release and stability assay development and method transfer for preclinical candidates.

• Have scientific oversight of assay development and structure-function studies that are required for IND/CTA filings.

• Streamline and integrate work packages between Genmab's analytical development and QC laboratories.

• Serve as a subject matter expert on ELISA-based release assays.

• Author and review of necessary documentation, ensuring compliance with regulatory standards.

• Collaborating with internal and external stakeholders.

Requirements

• A PhD in a relevant life science field and three to five years of relevant industrial experience.

• At least two years of industry experience in a people management role.

• Understanding of ICH guidelines and regulatory requirements for biologics.

• Experience with developing and troubleshooting of binding and cell-based methods (e.g. ELISA, SPR, luminescence assays).

• Experience in partnerships with CRO's is a plus.

• Experience with statistical analysis (JMP) and Analytical Quality by Design (AQbD) principles is a plus.

• Proven ability to manage multiple projects in parallel and adjust priorities effectively.

• Affinity for optimizing process flows to improve efficiency and reduce timelines and costs.

• Excellent relational and communication skills in English.

• Experience with stakeholder management across organizations.

• Motivated by creating an inclusive and collaborative work environment.

About You

• 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

Locations

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.

About Genmab

Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO™) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

Our commitment to diversity, equity, and inclusion

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. Learn more about our commitments on our website .

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com) .

Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL 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.