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  • 5 days ago

jobs description

Job Description

A fantastic opportunity for a Development Scientist looking to progress their career to a senior role. This is an exciting opportunity for an R&D professional in the pharmaceutical space.

Key responsibilities for this role include:
• Provision of technical expertise to support the development of Combination Products.
• Lead and provide technical support to a team responsible for activities such as metrology testing, engineering verification, design verification, device functional stability, biological evaluation, method development, transport & shipping studies.
• Provide technical mentorship to more junior members of the team, including guidance for technical issues and review/approval of documents.
• Leading the Development and Validation of Test Methods to support Design Verification Testing either to internal/external test facilities or manufacturing sites.
• Dealing with Viatris Affiliates and/or Third Partner Companies to support exhibit and registration... batches, through review and implementation of controls and additional requirements if needed such as manufacturing investigations.
• Responsible for testing of combination products within the Global Device Development portfolio including generation of protocols, oversight of execution of testing at external test facilities and writing of reports.
• Trending and statistical analysis of analytical data including compilation of technical reports to support combination product development lifecycle.
• Ensuring that the Combination Product meets any requirements for reliability, through implementation of appropriate controls and assessment of the product against suitable specifications.
• Responsible for compilation and review of technical documentation within GDD in line with global regulatory requirements, guidance and the latest regulatory and industry thinking.
• Lead and review device investigations and participate in GDD and technical investigation teams as required. Reporting and logging of aberrant results using Trackwise™.
• Responsible for following all EHS process and procedures

The minimum qualifications for this role are:
• Degree in Science/Engineering (Master's preferred)
• 4+ years experience in pharmaceutical and/or medical device development
• Experience in the development and validation of analytical methods
• Experienced in application of statistical techniques for data analysis.
• Working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485 would be an advantage
• Experience of writing and supporting regulatory submissions would be an advantage
• Highly driven and motivated person who can work as part of a flexible, dynamic team whilst taking responsibility for individual tasks
• Well-developed communication skills to lead or facilitate effective discussions. Able to communicate technical and/or project information to key stakeholders.
• Some travel will be required as part of this role.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
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Dublin Ireland

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