Phd-position - Viral Gene Therapeutics Formulation

vor 3 Monaten

Ludwigshafen am Rhein, Deutschland ABBVIE Vollzeit

We are looking for a highly motivated PhD student focusing on formulation development of Adeno Associated Virus (AAV) therapeutics in a cross-functional environment and hereby contributing to the establishment of formulation standards for AbbVie’s expanding gene therapy and AAV therapeutics pipeline.

The Biologics-CMC organization is using cutting-edge science and technology, and risk management to develop robust formulations for a broad spectrum of injectable drugs. During the last decade we have extended our focus towards one-time treatments to help patients with severe conditions. The PhD student will support the organization in understanding and implementing formulation approaches for AAV based therapeutics. The main areas of this PhD project include excipient selection and exploration to maximize storage stability, stress test establishment and determination of viral serotype specificities. This includes hands-on laboratory work as well as data analysis and statistical evaluation thereof. The PhD student will also be involved in the establishment of a sound formulation development process for AbbVie’s expanding pipeline of AAV therapeutics. This complex PhD project encompasses collaboration with various internal stakeholders such as NBE analytical, formulation development, bioassay, discovery, and global initiatives as well as external academic partners.

**Key responsibilities include**
- Planning and conducting of complex experiments
- Mammalian cell culture and virus production
- Data analysis and interpretation
- Statistical evaluation of data
- Biochemical/biophysical analysis of AAV (HPLC; MS, DLS, DSF, SEC-MALS, qPCR,)
- Formation of a robust process for formulation development of AAV therapeutics
- Evaluate and establish new state-of-the-art analytical methods
- Use of Quality by Design (QbD) approach
- International communication of research results via articles and oral presentations
- Support of pipeline project activities within Biologics Drug Product Development
- Diploma or master's degree in biochemistry, pharmacy, analytical chemistry, biophysics or equivalent
- Strong self-motivation and resilience
- Ability to navigate in a complex environment with multiple stakeholders
- Structured thinking
- Independent way of working
- Presentation of work progress to a broad audience from different areas via presentations, posters and written reports
- Proficient spoken and written English skills

**Desired add on Qualifications**
- Hands-on experience in one or more of the following analytical methods: HPLC, SEC-MALS, LC/MS, DLS, DSF
- Basic knowledge in virology
- Sound background in protein biochemistry and bioanalytical methods
- Basic understanding in pharmaceutic product development of biotherapeutics including formulation development

This position is for a 3-year assignment.

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