Associate Director Bioanalytical Science / Utrecht

Organisatie: Genmab
Locatie: Utrecht
Functie: Associate Director Bioanalytical Science
Vervaldatum: 25/05/2021
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  • Associate Director Bioanalytical Science

  • Utrecht
  • Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients. 

    Role

    The Bioanalytical Science team develops bioanalytical strategies to support the pre-clinical and clinical development of Genmab’s formats and compounds. We design, execute, interpret, and validate bioanalytical methods (Pharmacokinetic, Pharmacodynamic and Immunogenicity assays) and perform bioanalysis activities for both regulated (GLP, GCP) and non-regulated (mouse studies, exploratory toxicology, and dose range finding) studies. As such, we provide a strong foundation for informed decision-making at critical points throughout our entire drug development program.

    As Associate Director within the Bioanalytical science team, you will lead a team of Scientists and Research Associates to develop, qualify and validate assays for non-clinical trials enabling registration of new therapeutic products. You will participate and manage your team in GLP bioanalysis studies. You will work on and supervise the development of assays used by internal and external parties such as Contract Research Organizations (CRO’s).

    To achieve this, you keep yourself up to date with the latest developments in the field, such as novel technologies and requirements for regulatory documents. You will collaborate with CRO’s, transfer methods, write protocols and record scientific results in publications, regulatory documents, product development records and eventually in patents.

    Responsibilities

    Line management, mentorship, and development of a non-clinical bioanalysis team.You oversee the development, qualification, and validation of bioanalytical assays (e.g. ELISA and MSD) to support the Genmab pipeline.You will act as the Study Director in GLP bioanalytical studies performed in house.You will contribute to the vision and strategy of the Bioanalytical science department as a member of the Operational Management team.You take responsibility for Bioanalytical science topics within multi-disciplinary project teams.You will author necessary documentation and transfer methods to external parties (CRO’s).You will ensure compliance with regulations, i.e., GxP and FDA/EMA/ICH regulations.You act as a primary contact for external parties for non-clinical bioanalytical activities (validation, managing timelines, troubleshooting, analysis, etc.).You keep the department up to date with the latest relevant scientific information regarding bioanalytical assays and regulatory documentation.

    Requirements

    A completed PhD qualification and at least three years relevant industry experience in assay development and qualification; alternatively, a MSc degree with at least eight years’ relevant experience.You have industry experience leading and managing a team of both Scientists and Research Associates.You have experience with the development of bioanalytical (LBA) assays.You have experience in assay development to evaluate unwanted immunogenicity.You have experience as a Study Director in GLP studies and understand regulatory requirements.You can work to tight deadlines.You have excellent relational and communication skills in English (Dutch is an advantage, but not required).

    Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. 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 culture, all aiming to make a difference for cancer patients.

    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. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.

    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 to offer a temporary agreement for one year, followed by a contract for indefinite time regardless of seniority.

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