Mc Dermott Laboratories Limited

• Provision of technical expertise to support the development of Combination Products.
• Responsible for activities such as metrology testing, engineering verification, design verification, device functional stability, biological evaluation, method development, transport & shipping studies.
• Performing 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’s and the latest regulatory and industry thinking.
• Support of all R&D Lab activities including, Equipment calibration and Qualification, Documentation requirements, Trackwise records.
• Attending EHS training and maintaining responsibility for adhering to appropriate EHS procedures. Ensure the appropriate risk assessments are in place to perform required tasks.
• Support equipment qualifications, vendor calibrations and preventative maintenance in line with the laboratory qualification and preventative maintenance schedule as required.
• Lead general laboratory activities including; Procedure updates, generation of metrics, sample management, data review/ verification, instrument daily calibrations, shipping of samples.
• Responsible for following all EHS process and procedures

• Degree in Science/Engineering (Master’s preferred)
• 3+ 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.

• Excellent career progression opportunities
• Work-life balance initiatives
• Bonus scheme
• Health insurance
• Pension