Our client offers a range of diagnostic tools and tests for hospitals, labs and clinics, covering core, molecular and point of care diagnostics. This global healthcare leader is seeking a qualified and motivated
Principal Scientist
to join a dynamic R&D team developing novel assays.
Responsibilities
* Apply advanced scientific knowledge to projects. Conceive / design / plan / coordinate advanced independent and collaborative studies required for product development. Optimize assay conditions, improve product design and related processes and procedures, and troubleshoot technical issues.
* Be responsible for implementing and maintaining the effectiveness of the quality system. Understand and consistently follow documented procedures. Actively participate in routine maintenance, lab safety.
* Prioritize studies and activities to align with project goals and be responsible for timely project completion. Understand both theoretical and practical aspects of assay design and product development.
* Maintain a high level of professional expertise by staying current with scientific and industry literature, technologies and products. Develop and maintain internal and external customer contacts to maintain technical knowledge as required to accomplish objectives.
* Competent in making difficult technical decisions regarding priorities among projects / programs while ensuring the buy in of teams and leaders.
* Provide technical leadership and clear direction to the R&D organization across multiple sites in the area of lateral flow and invitro diagnostic devices.
* Provide technical and scientific leadership to other team members including providing assistance in study design. Provide training/coaching to lower level scientists.
* Create and maintain development standards, training programs and operating procedures that ensure all development activities meet regulatory guidelines and comply with the Quality System.
* Develop and maintain relationships with third level institutions, engineering test labs, key suppliers and appropriate consulting work providers.
* Collaborate closely with functional areas such as Quality, Manufacturing and Regulatory to support external audits and certification activities. This includes preparation as well as response to the audit findings.
Education & Experience
* PhD qualification in relevant field.
* 5+ years of invitro diagnostics / assay development and biologics essential with a strong Molecular and Biochemical background.
* Skill in optimizing assay design and conditions, including DOE optimization where appropriate.
* Advanced skills in statistical analysis.
* Expertise in design and optimization of serological diagnostic tests.
* Willing to take on new and challenging assignments and to implement new ideas or alternative solutions.
* Capable of adjusting to dynamic working environment and changing priorities, and of ensuring timely completion of assigned tasks.
* Strong analytical and quantitative skill