Process Development Scientist (m/f/d)

80331 München
31.10.2018

Daten dieser Anzeige

Job-ID: 009065439
Process Development Scientist (m/f/d)

via experteer GmbH

Germany

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Characterizing drug candidate molecules to support the determination of protein primary structure for drug substance and drug product Characterizing candidates with respect to attributes and their susceptibility to modification during process and product development activities including the use of mass spectrometry coupled with a variety of separation techniques, including liquid chromatography and capillary zone electrophoresis to identify, characterize, and quantitate post-translational modifications and other quality attributes Developing and qualifying product-specific mass spectrometry based Multi-Attribute Method that will be implemented in a regulated environment Familiarity with automation as it pertains to sample preparation and data analysis Developing and optimizing sample preparation protocols and MS-based technologies to reduce time and material requirements during all phases of candidate selection with emphasis on primary structure/glycan structure elucidation, determination of product purity profiles, product attribute criticality, and meeting the quality target product profiles to achieve the target product profile Development and qualification of product specific release, stability, and characterization assays Working collaboratively with other scientists as part of a cross-functional team to define strategies for protein mass spectrometry testing, performing data analyses, and developing high throughput strategies to monitor attributes in support of the QTPP Liaison as the designated subject matter expert in mass spectrometry and act as the key contact person for functional counterparts in external and internal collaborations Responsible for Tech Transfer Activities of the mass spectrometry based procedures/methods to internal or external customers

> Process Development Scientist (m/f/d) Standort: Greater Munich Gehalt: vertraulich Our mandator is the global leader in the pharmaceutical Biotech Industry and develops innovative and best in class agents in the area of Oncology/Hematology, Immunology, Nephrology, Oesteoporosis and many more. For the Department of Process Sciences we are searching as soon as possible for a dedicated and highly motivated Process Development Scientist (m/f/d) Standort: Greater Munich Your tasks Characterizing drug candidate molecules to support the determination of protein primary structure for drug substance and drug product Characterizing candidates with respect to attributes and their susceptibility to modification during process and product development activities including the use of mass spectrometry coupled with a variety of separation techniques, including liquid chromatography and capillary zone electrophoresis to identify, characterize, and quantitate post-translational modifications and other quality attributes Developing and qualifying product-specific mass spectrometry based Multi-Attribute Method that will be implemented in a regulated environment Familiarity with automation as it pertains to sample preparation and data analysis Developing and optimizing sample preparation protocols and MS-based technologies to reduce time and material requirements during all phases of candidate selection with emphasis on primary structure/glycan structure elucidation, determination of product purity profiles, product attribute criticality, and meeting the quality target product profiles to achieve the target product profile Development and qualification of product specific release, stability, and characterization assays Working collaboratively with other scientists as part of a cross-functional team to define strategies for protein mass spectrometry testing, performing data analyses, and developing high throughput strategies to monitor attributes in support of the QTPP Liaison as the designated subject matter expert in mass spectrometry and act as the key contact person for functional counterparts in external and internal collaborations Responsible for Tech Transfer Activities of the mass spectrometry based procedures/methods to internal or external customers Your qualifications Doctorate degree, Master's degree and 4 years of scientific experience, or Bachelor's degree and 6 years of scientific experience More than 3 years of scientific experience within the biotech industry, experience to include data analyses, statistical analysis, setting acceptance criteria in support of process development, process/method transfers and comparability studies Proven experience with Thermo mass spectrometers, Agilent and Waters LC systems, and corresponding data acquisition software such as Chromeleon and Empower Experience with mass spectrometry data processing software (BioPharma Finder, Byonic/Byos, Expressionist, Pinpoint, Skyline) Expertise with statistical software Possessing strong laboratory work skills including the design and performance of scientific experiments and the interpretation of results Strong written and verbal communication skills in German and English Strong presentation skills as well as attention to quality and details complete the profile of the selected candidate Jetzt bewerben

Pharma, Chemie, Med.-/ Biotechnologie

Projekt- und Produktmanagement/ Qualitätsmanagement

Forschung & Entwicklung

Chemie/ Pharma/ Biotechnologie

Angestellter/ Fachkraft

Vollzeit

80331 München