The primary purpose of this position is to develop analytical assays for protein and conjugate vaccine antigens. The incumbent will be responsible for the design and execution of method qualification and method transfer in support of vaccine materials release and stability testing for early phase vaccine programs. Assays of primary responsibility will include separation-based, spectroscopic-based techniques as well as mass spectrometry. Work is expected to be done in a compliant manner according to SOPs and GLP guidelines when applicable.
- This individual should be able to identify key vaccine DS and DP quality attributes and provide hands on experimental support to develop robust analytical assays. This individual should be familiar with basic regulatory expectations around product control strategies and the ICH guidelines for method qualification. The candidate will be expected to contribute to the selection of the methodology and techniques to be used.
- In this position, the individual will design, plan, and execute assay development, qualification and transfer studies with a high degree of independence to support the release, stability, and characterization of vaccine drug substances and drug products (GLP).
- The candidate will be expected to provide routine sample analysis to support process and formulation development activities. The individual is expected to independently analyze and interpret experimental data, and provide conclusions.
- In this position, the individual is expected to effectively collaborate with colleagues within Vaccine Research and Development Early Bioprocess, Analytical, and Formulation Development (VRD-EBPD) and appropriate partner lines. They will be expected to share and present their work in relevant project based meetings and to author appropriate documents.
- The individual is expected to manage daily, weekly and monthly laboratory activities, such as monitoring of equipment, completion and review of equipment logbooks, periodic laboratory cleaning and managing the laboratory waste, checking PMO status of lab equipment and resolving discrepancies. Manage storage of reagents and test solutions in accordance with departmental procedures.
- The individual may be responsible to supervise other analysts.
- PhD in Chemistry, Biochemistry, or related discipline with at least 2 years of academic, pharmaceutical, or biotechnology postdoctoral experience or an MS plus 7 years of related work experience is required. Experience in vaccine analytical assay development is a major plus.
- A strong background in separation-based analytical techniques and qualification using ICH guidelines is essential. Experience with applying these methodologies for biomolecules, such as proteins is preferred. Proficiency and ability to utilize techniques such as HPLC, CE, and UV-Vis to develop methods to analyze potential vaccine antigens and other vaccine components
- Proficiency with personal computers including word processing, spreadsheets, PowerPoint and relevant scientific software is desirable. Strong verbal and written communication skills are required.