This qualified and motivated Senior/Principal Scientist will join a dynamic R&D team developing novel assays. This individual will independently manage complex, long-duration projects, product improvements and investigations. He or she will anticipate, recognise, and resolve technical problems and identify opportunities for product improvements. He or she will act as an independent contributor or lead scientist and will interact/coordinate with other groups and functions on project development and innovation. The candidate will analyse 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.

The Position

• Project Management, independently manage cross functional stakeholders to ensure R&D project alignment and compliance with pre-determined target product profile.

• Apply advanced scientific knowledge to projects. Conceive/design/plan/coordinate advanced independent and collaborative studies required for product development. Optimise 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 and adhere to strict design control procedures.

• Actively participate in routine maintenance and lab safety.

• Prioritise 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 organisation across multiple sites in the area of lateral flow and in vitro diagnostic devices.

• Provide technical and scientific leadership to other team members including assisting 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, 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.

The Person

• 10+ years of in vitro diagnostics/assay development and biologics essential with a strong Molecular and Biochemical background.

• Skill in optimising assay design and conditions, including DOE optimisation where appropriate.

• Expertise in design and optimisation 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.

• Knowledge of regulatory standards and guidelines particularly in the diagnostics industry is desirable.

• Advanced skills in statistical analysis.

• Strong analytical and quantitative skills. Leadership Characteristics: Making Complex Decisions

• Excellent problem-solving methodology, using industry-accepted concepts and tools to solve complex technical problems in creative and effective ways.

• Complex problem-solving and decision-making based on the available data.

• Leverages personal experience and has an open and collaborative style of communicating effectively.

• Writes and presents effectively; adjusts to fit the audience and the message; strongly gets a message across.

• Proficiency in technical writing for data summary and technical reports.

• Effective at building strong cross functional relationships with the key stakeholders.

• Ability to develop relationship and collaborate with external suppliers and Key Opinion Leaders within related industries.

Requirements

• Minimum Education: PhD plus 5 years of research or B.S./M.S. with 10 years industrial experience.

To learn more about this role, apply online or contact Lewis Muray at HRM Search Partners.