Company Profile:
Here at Hays, our client, a well-established pharmaceutical company in the Dublin area, is seeking a Principal Scientist in the area of Combination & Product Development.
Job Description:
It is a permanent role encompassing the full scope and breadth of a large product portfolio, involving scope, customization, and development. This position is well-suited for those who enjoy working in a dynamic, fast-paced environment and can provide mentorship and guidance to junior employees.
Key Responsibilities:
1. Provision of subject matter expertise to support the development of Combination Products.
2. Lead a team to plan and execute design verification and reliability strategies.
3. Responsible for the technical interface between drug product and device teams during combination product development, ensuring formulation and manufacturing development activities are compatible and aligned with device development.
4. Develop design requirements and specifications based on characterization of comparator products, regulatory requirements, design intent, and user requirements.
5. Develop test methods and specifications to assess device functionality and product performance, including evaluation, procurement, and implementation of new, state-of-the-art lab testing equipment as applicable.
6. Responsible for material assessment of device components, including biological evaluation, extractables profiling, and material certification.
7. Provide technical support to manufacturing sites during filling and assembly process development by providing device controls and sampling plans.
8. Use statistical techniques or data analysis such as hypothesis testing, confidence and tolerance intervals, regression, capability analysis, DOEs, etc., to inform design decision-making and conclusions for deliverables like test method validations, design characterizations, and verification, and reliability.
9. Lead support activities for external and internal audits and inspections as applicable.
Minimum Qualifications:
1. Degree in Science/Engineering (Master’s preferred).
2. 7+ years of experience in pharmaceutical and/or medical device development, with a minimum of 3 years working in combination product performance.
3. Working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485 would be an advantage.
4. Experience in the development and validation of analytical methods.
5. Experience in the application of statistical techniques for data analysis.
6. Experience writing and supporting regulatory submissions.
7. Highly driven and motivated person who can work as part of a flexible, dynamic team while taking responsibility for individual tasks in a Subject Matter Expert role.
8. Some travel is required for this role.
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Science, Product Management, and Design
Industries: Staffing and Recruiting and Pharmaceutical Manufacturing
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