Principal scientist bioanalytics

Novartis pharma gmbh

• Oberhaching

vor 30+ Tagen (01/03/2020)

stellenbeschreibung

Job Description 8 biosimilars across immunology, oncology and endocrinology are already on the market, and Sandoz Biopharmaceuticals has a leading biosimilars pipeline with additional molecules in various stages of development. As a Principle Scientist you are responsible for providing high quality analytical data and expertise to contribute to the future success of our biosimilars development

Your Responsibilities

:

• management of bioanalytical cros and/or external partner laboratories, including planning and organization of outsourced bioanalytical activities, as well as establishing processes and improvements for outsourcing of bioanalytical methods - supervision of external activities for development, optimization, and validation of bioanalytical methods / immunoassays (e. g. elisa, ecl, large-molecule lc-ms) for analysis of pk, pd, and immunogenicity - coordination of the timely analysis of serum samples from preclinical and clinical studies at external laboratories (e. g. cros), including result reporting and interpretation as well as review and/or creation of bioanalytical plans, reports and sops for bioanalytical sample analysis - evaluation of new technologies - creation of international registration documents and interaction with authorities (where appropriate) - participation in internal and external project teams as well as presentation of results - active contribution to budget forecast minimum requirements what you'll bring to the role:
• doctoral degree (phd) with 2-3 years or master degree with 5 years of work experience - experience with outsourcing of biological assays to cros - knowledge of immunogenicity, pharmacokinetics and pharmacodynamics of biotherapeutics desirable - scientific experience in bioanalytical techniques, e. g. immunoassays and lc-ms - excellent knowledge of the english language - knowledge of relevant software tools preferred (including lims systems) - strong communication and interpersonal skills;

demonstrated ability towork in a team and in a fast paced environment desirable requirements:

• may require up to 20% travel - good skills in presentation and scientific writing - working experience in a highly regulated environment is a plus why consider sandoz? our number 1 priority is to pioneer patient access to better healthcare. we are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an fda-cleared digital therapeutic. and we never stop asking:

how can we continue to pioneer access in an ever-more digital and global world? the answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take calculated risks. sandoz, a novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics. join us, and help reimagine access to medicine. sandoz stands up for equal opportunities and for the integration of persons with disabilities. hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability. division sandoz business unit biopharma sz location deutschland site oberhaching (bei münchen) company/legal entity hexal ag functional area forschung & entwicklung job type vollzeit employment type unbefristet

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