This is a laboratory-based position within the Vaccine Research and Development - Analytical Development group. The candidate will develop robust analytical assays in support of early vaccine development for a range of moieties such as proteins, mRNA, and glycoconjugates. Assays include molecular biology-based techniques such as but not limited to ddPCR, qPCR, RT-PCR, nucleic acid (NA) extraction and cloning, and gel electrophoresis . In addition, the candidate will provide analytical support for bioprocess and formulation development by performing routine and non-routine sample testing.ROLE RESPONSIBILITIES
- The individual is expected to be familiar with the specific requirements and the associated guidelines for bioassays, as well as be familiar with the ICH guidelines for method qualification.
- Contribute to the selection of the methodology and techniques to be used.
- Independently design, plan, and execute assay development, qualification and transfer studies to support the release, stability and characterization of vaccine candidates
- Independently analyze, interpret, provide conclusions and present experimental data internally
- Perform routine sample analysis
- Collaborate with colleagues within Vaccine Research and Development - Bioprocess, Analytical, and Formulation Development and appropriate partner lines
- Author and review laboratory methods and reports
- Keep abreast of scientific/ technological development by participating in scientific meetings/ seminars and through regular scientific review
- Where applicable, perform job responsibilities in compliance with GLP and all other regulatory agency requirements
- Perform timely notebook entries and review for completed experiments.
- PhD in Molecular biology, 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 essential.
- A strong background in molecular biology techniques and qualification using ICH guidelines is essential.
- Proficiency with personal computers including word processing, spreadsheets, PowerPoint and relevant scientific software is desirable. Strong verbal and written communication skills are required.
- Experience with applying these methodologies to biomolecules, such as DNA and RNA is preferred. Proficiency and ability to utilize techniques such as qPCR, ddPCR, RT-PCR, NA sequencing, gel electrophoresis to develop methods to analyze potential vaccine antigens and other vaccine components.
- Background in nucleic acid structure, function and characterization is a major plus.
- Experience with documentation of laboratory notebook in an electronic format.
Standard laboratory conditions - sitting, standing, primarily lab based
Ability to perform mathematical calculations and ability to perform complex data analysisNON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Occasional travel might be needed based on business needsOther Job Details
Eligible for Relocation Package
Eligible for Employee Referral BonusSunshine Act
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Research and Development