Analytical Science and Technology Lead (ASTL)

The Analytical and Materials Science Function is a global team supporting GSK's new product introduction into the market and manufacturing sites with projects aligned to technology transfers, material changes and rapid resolution of RCAs associated with business-critical supply issues., The Analytical Science and Technology Lead (ASTL) supports the delivery of business-critical projects with the provision of expertise linked to all aspects of the late-phase of the product lifecycle (PhIII/PPQ/Post Commercial) for key GSK products (the ASTL is accountable for one or more key GSK products). The ASTL has accountability for the Product Strategy (end to end) taking accountability from the R&D team at commercial launch. The role is responsible for managing and defining appropriate comparability studies and suitable characterization strategies to support post-approval changes.,

• Provide technical expertise for programs, projects and activities related to the specific product/s under the ASTL accountability to ensure business priorities and targets are met eg. NPI, product transfers, change management, regulatory submissions.
• Manage and define comparability studies and suitable characterization strategies to support post-approval changes for the accountable product/s.
• Partner with teams across the business in a matrix-fashion in order to meet asset needs, and to identify and mitigate risks i.e. with R&D, GSC (site and central), Technical (site and central), Regulatory.
• To ensure that method knowledge is embedded in the onward Technical Transfer to other GSK sites (and to external sites).
• To compile and recommend acceptance criteria for release and stability tests to feed into the comparability strategies around TT/process change/scale change/material change. To provide input and expertise into comparability protocols and summary reports for regulatory changes/documents.
• To take non-routine physical properties data and recommendations from Materials Science, and build into comparability assessment reports, if applicable.
• To drive PAT and new technologies for testing linked to the Product Control Strategy (PCS)
• Own and accountable for the Analytical Product Strategy (APS). Maintenance and update of the APS through the post-approval product lifecycle eg. recommending specification strategy, recommending novel technologies based on product needs. Ensure that methods developed by R&D are robust with respect to product lifecycle, focusing on the highest risk / most complex methods.
• Support analytical and comparability aspects for the regulatory submission of accountable product (Eg. support authoring regulatory files and RTQs responses relevant to areas of expertise).
• Provide expertise for all aspects of root cause analysis investigations (RCA) related to the accountable product., We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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This role would suit a highly motivated person who has strong experience working in a cross-functional, global supply organisation with first class stakeholder management and a track record of delivery. As a subject-matter expert you will be degree-qualified with excellent scientific knowledge. The role requires strong relevant knowledge and experience in order to manage comparability studies and other key activities (to support product life cycle). You must also have demonstrably strong people skills, be resilient and calm under pressure, have a strong continuous improvement mindset, and a proven ability to drive performance.,
• Relevant experience and qualifications (eg; BS in a scientific discipline -pharmacy, chemistry, biology, biochemistry, or related technical discipline).
• Deep and specific technical knowledge of analytical methods related to pharmaceutical dosage forms for oral, injection and inhalation administration (eg; UPLC, HPLC and LC-MS).
• Strong understanding of drug substance and drug product dose forms manufacturing disciplines and relationship in testing and control strategies.
Preferred Qualifications:
• Knowledge and relevant experience on Oligonucleotides analysis.
• Extensive drug substance development experience
  
  GSK offers a range of benefits to its employees, which include, but are not limited to:
• Competitive base Salary
• Annual bonus based on company performance
• Opportunities to partake in on the job training courses
• Opportunities to attend and partake in industry conferences
• Opportunities for support for professional development
• Access to healthcare and wellbeing programmes
• Employee recognition programmes
If you would like to learn more about our company wide benefits and life at GSK we would suggest looking at our webpage Life at GSK | GSK. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.