Job Title: Principal Scientist, Device and Product Performance
We are seeking two highly skilled Principal Scientists to join our team in Dublin on a permanent basis.
About the Role:
* Lead the design, development, and performance evaluation of drug-device combination products ensuring they meet regulatory and quality standards.
* Drive technical excellence, innovation, and patient-centric solutions with your expertise.
Responsibilities:
Technical Expertise:
* Provide subject matter expertise to support the development of Combination Products.
* Plan and execute design verification and reliability strategies.
* Be the technical interface between drug product and device teams during combination product development ensuring formulation and manufacturing development activities are compatible and align with device development.
Design Requirements:
* Develop design requirements and specifications based on characterization of comparator products, regulatory requirements, design intent, and user requirements.
Testing and Evaluation:
* Develop test methods and specifications to assess device functionality and product performance including evaluation, procurement, and implementation of new lab testing equipment as applicable.
* Responsible for material assessment of device components including biological evaluation, extractables profiling, and material certification.
Maintenance and Improvement:
* Provide technical support to manufacturing sites during filling and assembly process development by providing device controls and sampling plans.
* Use statistical techniques or data analysis such as hypothesis testing, confidence intervals, regression, capability analysis, DOEs, etc., to inform design decision making and conclusions for deliverables like test method validations, design characterizations, and verification.
Requirements:
* Degree in Science/Engineering (Masters preferred).
* 7+ years experience in pharmaceutical and/or medical device development.
* Working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485 would be an advantage.
* Experience in the development and validation of analytical methods.
* Experienced in application of statistical techniques for data analysis.
* Experience of writing and supporting regulatory submissions.
* Highly driven and motivated person who can work as part of a flexible, dynamic team whilst taking responsibility for individual tasks in a Subject Matter Expert role.
* Well-developed communication skills to lead or facilitate effective discussions. Able to communicate technical and/or project information to key stakeholders.