Passion for Innovation. Compassion for Patients.
With over 120 years of experience and approximately 19,000 employees in more than 30 countries/regions, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.
In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life.
In Oncology, we are driving innovation in solid tumours and blood cancers, founded on breakthrough science from our own labs in Japan. We aspire to create better tomorrows for people living with cancer and their loved ones.
Our European headquarters are in Munich, Germany, and we have affiliates in 15 European countries and Canada.
For our site in Pfaffenhofen/Ilm we are seeking highly qualified candidates to fill the position:
Scientist (m/f/x) Formulation Technology - Analytics of Biologics
Purpose of the function:
The "Scientist (m/f/x) Formulation Technology", with a focus point: Analytics of Biologics, will be responsible for the planning, organization and hands-on technical support of analytical activities in our Formulation Technology Research Laboratory group for ADC Process Development. In the context of drug product development, the scope of this position will be the establishment of various analytical methods for measuring and assessment of the quality attributes and physicochemical characterization of Biologicals, with focus on parenteral oncology formulations, e.g. ADCs. The position involves both scientific and hands-on support of the operational team members.
Internal transfer and establishment of analytical methods for biologics, including ADCs
Planning, coordination, statistical evaluation and reporting of analytical results related to ADC process development and upscaling activities, incl. stability studies in a GLP environment
Assessment of various quality attributes of ADC process development and process characterization samples using analytical methods (e.g. CE, HPLC, ELISA)
Operation of standard software such as MS Office and evaluation of analytical data using device-specific software (e.g. Empower ®)
Co-ordinating the maintenance and qualification work of analytical equipment
Scouting, evaluation and onboarding of new analytical technologies for ADC drug products
Co-working with a young development team for expanding the group analytical capabilities with focus on physicochemical characterization and analytical quality assessment of Biologics, as well as laboratory automation and the occupational health and safety concepts for handling of high potent compounds
Contribute to late-stage drug product development laboratory activities
Creation of risk analyses within the framework of formulation and process development of biologics
Supporting the team in creating and reviewing of manufacturing protocols and reports
Collaboration with various international multidisciplinary project teams (incl. colleagues from Japan, US and Europe)
University degree (in Biochemistry, Chemistry, Pharmacy, Molecular Biology or related disciplines), ideally with a master’s degree or with equivalent work experience within pharmaceutical/biotechnological companies (focus on analytical of Biologics)
In-depth knowledge and hands-on expertise in analysis of parenteral Biologics; incl. HPLC, Capillary electrophoresis and ELISA. Preferably, with at least two years’ experience within a professional lab
Experience with Empower, Karat, or OpenLabs is a plus
Reliable, independent, with sense of responsibility and precise working style
Hands-on mentality and, above all, enjoyment of working in a team
Basic knowledge of the regulatory and ICH guidelines
Intercultural competence and collaborative working skills
Very good written and oral communication skills in English and German
Very good IT skills (MS Office, SAP etc.)
Excellent Benefits
Work-Life Balance
Growth and Development
Health and Wellbeing Support