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The Company Will Undertake the Following Activities:
- Engage in business development and scientific affairs activities to define relevant application areas for new technology, enable key collaborations with academics and industry partners, and enable publications in key scientific journals.
- Enable technology assessments required for in-licensing and M&A activities.
- Align product development activities to ensure that they meet regulatory guidelines in place for approval in various market segments (ISO, Design Control, QSR, DFSS, SWGDAM, AOAC, ICH, etc.). Enable voice of customer (VOC) related activities, help define specifications, and implement and execute verification and validation plans.
- Help define software requirements for the application, including result interpretation
- Enable systems integration needs
- Design and help implement clinical trials under GCP
- Enable technical marketing activities required for product launch and post-launch.
- Present technology and applications at key scientific conferences and to customer groups and industry partners.
- Ensure robust manufacturing by enabling detailed and sound transfer procedures, implementing process validation procedures, and establishing procedures for non-conforming product evaluation and CAPA investigations.
- Assess regulatory requirements required for the successful commercialization of products in the molecular testing space.
- Work with government agencies and regulatory bodies to define policies for improving human health and public safety.
- Work with educational organizations to promote greater awareness of the science of biology and its applications.
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