Group head bioanalytics

Sandoz international gmbh

• Oberhaching

neues Angebot (05/03/2020)

stellenbeschreibung

Job Description Stellenbeschreibung 8! This is the amount of biosimilars across immunology, oncology and endocrinology that are already on the market, and Sandoz Biopharmaceuticals has a leading biosimilar pipeline with additional molecules in various stages of development! Job purpose:

As Group Head Bioanalytics you are responsible to provide expertise to define the bioanalytical strategy and ensure high quality analytical data to contribute to the future success of our biosimilars development

Your Responsibilities

:

• represent bioanalytics for assigned project internally and externally and provide scientific input to the bioanalytical testing strategy for pk, pd and immunogenicity analysis as well as strategic planning activities. - management and supervision of scientific and technical activities in bioanalytical laboratories, incl. resource and time planning - ensure timely development and validation of bioanalytical pk, pd and immunogenicity assays as well as analysis of serum samples for the support of preclinical and clinical trials with biopharmaceutical drugs (biotherapeutics, (glyco) proteins) (high quality, on time, in budget). - preparation and review of scientific documents and international registration documents;

support interaction andcommunication with ha. - ensure compliance with legal requirements (e. g. radiation safety, biological safety, worker safety) and regulatory (e. g. ich, glp, gclp compliance) as well as company guidelines and ensure preparation of sops, analytical plans and reports according to glp / gclp in the time expected - responsibility for the professional development of scientific associates and support resource planning for the bioanalytical group - budget planning (target, lf, investments) and accounting of expenses. mindestanforderungen what you'll bring to the role:

• phd in natural/biological sciences - 5-10 years of practical experience in bioanalytics and immunology - experience in analytical assay development (elisa, bioassays) and validation - expertise in immunogenicity and/or biomarker, experience in quality systems and familiarity with regulatory agencies/functions - experience in project as well as in people / management - excellent interpersonal, leadership and teamwork skills - german and english proficient in written and spoken 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, fearless people are empowered to ask new questions, make ambitious decisions and take risks. sandoz, a novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.

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