As a seasoned professional in biologics and immunoassay development, you will be responsible for designing and optimizing assays to drive product improvements.
Key Responsibilities
* Project Management: Independently manage projects and product improvements using established principles and procedures
* Product Development Lifecycle: Apply advanced scientific knowledge to projects, conceiving, designing, planning, coordinating, and optimizing products and processes
* Design Control and Risk Management: Develop and maintain risk management files independently, organizing data for evaluation and decisions
* Problem Solving and Investigations: Identify root causes and drive resolutions with minimal supervision, applying problem-solving methodologies and arriving at timely conclusions
* Technical Documentation: Draft defined procedures for testing and data analysis in support of product development lifecycle and root cause investigations
* Knowledge Sharing: Present technical information to stakeholders, sharing knowledge and expertise with others, and mentoring or teaching to facilitate timely resolution of product and process technical issues
* Safety & Quality Compliance: Consistently follow documented procedures, participate in routine maintenance, lab safety, and audits
This role requires an expert in assay development and biologics with a strong molecular and biochemical background. The ideal candidate has experience in optimizing assay design and conditions, and expertise in design and optimization of serological diagnostic tests.
To succeed, you must have excellent analytical and quantitative skills, strong communication skills, and the ability to work independently and collaboratively in a dynamic environment.