Purpose of the Job
This qualified and motivated Senior Scientist will join a dynamic R&D team developing novel assays. This individual will conceive, plan, design, and conduct advanced studies. He or she will anticipate, recognize, and resolve technical problems. He or she will act as independent contributor or lead scientist and will interact/coordinate with other groups and functions on project development and improvement. The candidate will analyze data from multiple experiments, formulate conclusions, and determine future experiments. The candidate should have expertise in molecular biology and protein chemistry techniques for protein expression and assay development. The successful candidate must have strong analytical and quantitative skills, excellent oral and written communication skills, and a track record of successful independent and collaborative research.
Major 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 & Competencies
10+ 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 skills.
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