A career is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
This strategic, scientific and operational Project Representative role supports development of biopharmaceuticals and antibody-drug conjugates. He/She will be responsible for managing the overall nonclinical drug disposition (i.e. Adsorption, Distribution, Metabolism and Excretion) contribution to NBE projects from hit discovery through Life Cycle Management (LCM) thus fulfilling internal and regulatory requirements. He/She will be responsible for defining the appropriate project plan, for ensuring that studies are conducted on time and with the required quality, and for scientific content of regulatory submissions. He/She will qualitatively integrate the various bioanalytical and immunogenicity data to interpret the drug disposition of the NBE and to perform the immunogenicity risk assessment for assigned projects. He/She will collaborate with the cross-functional Discovery Project Team for research projects and the Global Early Development subteam for development projects.
Who you are:
>5 yr experience drug discovery/development of biopharmaceuticals
Excellent knowledge of drug development & discovery processes
Subject matter expert for immunogenicity and/or nonclinical DMPK
Solid understanding of translational sciences, regulatory requirements
General knowledge of disease biology and pharmacology
Strong leadership and influencing skills
Good intercultural understanding
Fluent spoken/written English
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
EMD Serono - the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada – is engaged in the discovery, research and development of medicines for patients with difficult to treat diseases. We are committed to transforming lives by developing and delivering meaningful solutions that help address the therapeutic and support needs of patients.