This qualified and motivated Scientist will join a dynamic R&D team developing novel assays.
They will conceive, plan, design, and conduct advanced studies; anticipate, recognize, and resolve technical problems; act as an independent or lead scientist; and coordinate with other groups and functions on project development and improvement.
They will analyse data from multiple experiments, formulate conclusions, and determine future experiments.
The successful candidate must have strong analytical and quantitative skills and excellent oral and written communication skills.
Essential Duties and Responsibilities (Key Activities)
Draft and submit defined procedures, protocols in collaboration with global manufacturing sites to perform testing and data analysis in support of product development lifecycle and root cause investigations.
Product and Process Improvements: Investigate and support process improvements in New Product Introduction lifecycle.
Build and maintain awareness of industry regulatory standards.
Design and Development control and risk management: Under direction, develop and maintain Design and Development File and risk management files.
Sharing Knowledge: Prepare reports and may deliver presentations to internal groups.
Share knowledge and expertise with others in the work group.
Be responsible for implementing and maintaining the effectiveness of the quality management system.
Understand and consistently follow documented procedures.
Actively participate in routine maintenance and lab safety procedures.
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.
Carry out duties in compliance with established business policies and procedures.
Demonstrate commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.
Show professionalism with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices.
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.
Education / Experience / Skills
Minimum Education: Ph.D. or other relevant higher-level qualification in a scientific and/or technical field.
2 years' related work experience or an advanced degree is desirable.
Experience
Proven experience in design and optimization of immunological assays.
Willingness to take on new and challenging assignments and to implement new ideas or alternative solutions.
Capability to adjust to a dynamic working environment and changing priorities, ensuring timely completion of assigned tasks.
Skill in optimizing assay design and conditions, including DOE optimisation where appropriate.
Advanced skills in statistical analysis.
Expertise in design and optimisation of serological diagnostic tests.
Effective communication, writing, and presentation skills; able to adjust to fit the audience and the message.
Proficiency in technical writing for data summary and technical reports.
Ability to develop relationships and collaborate with external suppliers within related industries.
Integrity, high character, consistency, and a clear and visible set of values and beliefs; direct and transparent.
Strong analytical and quantitative skills.
Proven skills in cross-functional collaboration with Quality, Manufacturing, and Regulatory to support external audits and certification activities, including preparation and response to audit findings.
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