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.
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