Analytical Expert Gene Therapy (m/w)
The department 'Analytical Development and Quality Control Biotech Europe' is responsible for Biochemical Analytical Development, Quality Control and development and implementation of novel analytical technologies from pre IND (= Investigational New Drug) to BLA (Biologics License Application) and Launch. The main tasks of this operational unit are:
- Development and application of suitable and state of the art methods to test and characterize active pharmaceutical ingredients as well as process related impurities.
- Method development and validation as well as evaluation and implementation of novel, state of the art analytical technologies.
- QC testing (IPC, Release and Stability) of drug substance batches produced by the Clinical Supply Center.
- Development and application of automated procedures for sample preparation as well as purification and analysis of cellculture supernatants.
- Development and definition of control and testing strategies (including risk assessments, CQA assessments, QbD approaches).
We are looking for a highly motivated associate or scientist for the development and implementation of analytical methods for the characterization of gene therapy vectors (recombinant adeno-associated viral vectors or rAAV).
Your specific role
The position comprises predominantly the following tasks:
- Your main task is the development, implementation and validation of innovative methods for the analysis and characterization of viral particles for gene therapy applications, especially rAAVs, based on nucleic acid analytical, electrophoretic, spectroscopic, immunological and liquid chromatographic techniques.
- You are responsible for the analytical quality control and characterization of active pharmaceutical ingredients as well as process related impurities during clinical development until market approval.
- Furthermore, your task is the independent interpretation, evaluation and documentation of data and the generation of analytical reports in accordance to current regulations.
Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
For this interesting challenge, you bring the following qualification:
- A Master and/or PhD degree in life sciences with appropriate working experience in gene therapy or virology.
- Solid knowledge in the field of gene therapy and/ or virology as well as hands-on experience in working with viruses relevant for therapeutic applications (AAV, Lentiviruses, etc.).
- Hands-on experience in relevant methodologies like recombinant nucleic acid analytics (PCR, qPCR, ddPCR, gel electrophoresis), sequencing techniques (NGS, Sanger), spectroscopic methods (UV, SLS, DLS). Experience in electrophoretic methods (capillary electrophoresis, Western Blotting, FFF), liquid chromatographic separation methods (HPLC, SEC, SEC-MALS, IEC,RP) or immunological techniques (ELISA) would be an additional asset.
- Self-motivated, pro-active, responsible, result-oriented and an excellent team player.
- Fluent English and/or German language skills (written and spoken).
Roche is an equal opportunity employer.
This position is a full-time position limited to three years.
Internal Job Posting until: 3rd of July
Remuneration bandwidth: MTV/AT01
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You can reach us from monday to friday from 08:30 am - 4 pm by phone: (+49) (0) 621-759 1616.