Process Development Scientist (m/f/d)

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)

  • Bereich:

    Medical

  • Berufssparte:

    Forschung/Entwicklung

  • Arbeitsregion:

    Greater Munich

  • Art der Anstellung:

    Permanent

  • Kennziffer:

    24988

  • Aktualisierung:

    06.12.2018

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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

Ihr Ansprechpartner

Inken Steinkamp
Personalberaterin

Anschrift

Optares Medical GmbH & Co. KG
Inken Steinkamp
Heiligengeist Höfe 8
26121 Oldenburg