This Assay Development Scientist will develop suitable methods for release and stability assessment of pandemic and seasonal sa-mRNA drug substance and drug product. This position will work on the analytical assays required to control the quality of Toxicology and Phase I/II/III CTM. This resource will lead development of Molecular Biology assays and supporting process teams for DS and DP development work, developing suitable content assays for dosage determination of DP, interact with QC/CROs for analytics surrounding the DS and DP and lead documentation activities for CMC-analytics related to tech transfer to QC.
*This position will be located in Holly Springs, NC for the first phase of the project (6months to 1 year) then will move to Waltham, MA (12 miles outside Boston, MA).
- Review and preparation of new and revised Standard Operating Procedures associated with the functions of the Analytical Testing for support of early phase Clinical Trial Material (CTM).
- As required, provide analytical assay execution in support of vaccine process and product development programs, e.g. qPCR, RT-PCR and digital PCR for process development or process improvements.
- Perform review of analytical documents, checking for compliance with Good Documentation Practices (GDPs) and Good Laboratory Practices (GLPs)
- Oversee and coordinate analytical laboratory equipment qualification documents.
- Oversees and advises on the development of Standard Operating Procedures, Guidelines and other tools to support early phase CTM testing support.
- Supports the quality and compliance training program; collaborates with operations management to ensure staff training is current as required by their role.
- Works with TD-QA team as liaison to ensure all quality attributes are in place to support GLP testing.
- Work with TD-QA to close gaps related to GLP or GxP lab requirements
- Evaluates procedures and processes affecting quality and proposes process improvements when applicable.
- Experienced and very knowledgeable of FDA, EMA, and other regulatory regulations.
- Experienced in managing concurrent complex projects/programs (e.g. process improvement initiatives for lab).
- Proactively identify development and improvement opportunities
- Able to work under tight deadlines.
- Functions effectively as core team member on multiple concurrent projects and leads small projects and establishes work processes.
- Data collection and reporting with knowledge of GLP/GMP environments.
- Work closely with the Separation, Biochemistry, and Mass Spec groups within TD-Analytical to provide technical expertise for GLP/GxP requirements or lab support for process improvements or assay development support.
- Provide support on reviewing documentation in notebooks and reviewing data in LIMS for specific lab based processes that the employee is trained on.
- Interface with electronic business systems (e.g, LIMS, SAP, EDMS)
- Bacheolor’s Degree or Master’s Degree or PhD in related scientific field required.
- Minimum of 8+ years of experience with BS, or 5+ years of experience with MS, or 0 years of experience with a PhD.
- Effective delivery of objectives in a complex matrix environment
- Effective verbal & written communication skills in a cross functional environment
- Ability to present solutions to complex and strategic issues
- Excellent customer focus with demonstrated management of customer expectations
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Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.
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