Senior Scientist - Preclinical Release (Bioassays)

Senior Scientist - Preclinical Release (Bioassays)

Genmab

Utrecht, Netherlands

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.

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