Quality Manager providing support to ensure compliance of the Quality Operations in Grifols USA. Managing quality systems and processes for BioPharma products while collaborating with global teams.
About the role
- Project manager in bioanalysis overseeing project planning, execution, and reporting. Responsible for client interactions and adherence to scientific standards in a hybrid work environment.
Responsibilities
- Plan, execute, evaluate and report bioanalytical projects as the responsible scientist (m/f/d)
- Serve as Principal Investigator in accordance with Good Laboratory Practice (GLP) principles
- Draft, edit and review bioanalytical protocols and study reports
- Supervise the development and validation of bioanalytical methods for quantifying small-molecule active substances using (U)HPLC-MS/MS in line with applicable guidelines and internal procedures
- Support technical staff with analysis, review and discussion of analytical results and take responsibility for meeting timelines
- Discuss new project opportunities and advise clients on optimal project designs in connection with business development and sales
- Prepare cost estimates/quotations for bioanalytical projects
- Communicate project results and observations to clients on a daily basis
- Represent bioanalytical projects during client audits and health authority inspections in cooperation with the Quality Management department
Requirements
- Degree in a natural science, Master of Science or PhD in e.g. food chemistry, chemistry, pharmacy, biochemistry or biology
- Practical experience with pharmacokinetic analysis software (Phoenix) is an advantage
- High flexibility, strong team orientation and excellent communication skills
- Independent, structured and results-oriented working style
- Business-fluent German and English
- Experience with modern chromatographic techniques coupled to mass spectrometry (LC-MS/MS), and experience in peptide analysis by LC-MS/MS is desirable
- Experience with relevant control and data-analysis software is required (preferably Sciex OS, Thermo Fisher WATSON LIMS)
- Strong project management, problem-solving and analytical skills
Benefits
- Flexible working hours with a flextime arrangement (full-time: 37.5 hours per week) and 30 days of annual leave
- Attractive compensation and company pension plan
- Comprehensive onboarding and individualized training and development opportunities
- Flat hierarchies and an informal, first-name culture ("Du-Kultur")
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
No Education Requirement
Location requirements
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