Our clinical-stage vaccine client here in Boston, MA is looking to add a Senior Scientist, Clinical Assay Development to their team! Role will develop/optimizing clinical assays to support the clinical development of vaccines, have oversight of assay qualification and validation strategies and monitor/troubleshoot clinical assay performance both internally and at external testing partners.
- Providing internal technical expertise and capabilities for clinical assays development
- SME providing oversight of clinical assay development, qualification, validation and monitoring at external testing partners, including trending and tracking of assay performance at external testing partners
- Writing and reviewing internal technical documents and regulatory submissions.
- Reviewing technical documents from external testing partners
- Collaborating with external testing partners and other thought leaders on the development of state of the art technologies and approaches to clinical and immunological characterization assays
- Communicating technical information to Senior Management and external partners
- MS and a minimum of 3 years’ of experience or BSc and a minimum of 5 years’ experience in assay development or GLP clinical testing.
- The candidate should have the potential to participate in transformational changes in analytical development testing strategies within the vaccine industry.
- Self-starter and team player who can balance the needs of an entrepreneurial environment with the requirements of a structured GLP testing environment.
- Experience in managing and analyzing clinical testing data and information.
- Proficiency in statistical/analytical software (JMP, R, graphpad, etc.) for data analysis and tracking and trending.
- Demonstrated technical expertise in assay development and/or GLP clinical testing.
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required (up to 20-25%).