Job Description
Principal Scientist
In this challenging role, you will provide subject matter expertise to support the development of Combination Products. This includes leading a team to plan and execute design verification and reliability strategies.
You will be responsible for 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.
Key Responsibilities:
* Developing design requirements and specifications based on characterisation of comparator products, regulatory requirements, design intent and user requirements.
* Designing and implementing test methods and specifications to assess device functionality and product performance.
* Material assessment of device components including biological evaluation, extractables profiling and material certification.
Requirements
* Degree in Science/Engineering (Master's 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 an advantage
What We Offer
* A dynamic work environment
* Opportunities for professional growth and development
* Competitive benefits package