Job Purpose
This role is responsible for the leadership on all the analytical aspects of product lifecycle (PPQ/Commercial) for key GSK products and supports delivery of business-critical projects globally. The ASTL is accountable for one or more key GSK products. The ASTL has ownership for the end to end Analytical Product Strategy taking accountability from the R&D Analytical Leader at Process Performance and Qualification (PPQ) stage.The role is responsible for leading and defining comparability studies and suitable characterization strategies to support post approval changes.
Key Responsibilities
• To provide technical analytical leadership 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.
• To be accountable for the Analytical Product strategy (APS). Maintenance and update of the APS through the post-approval product lifecycle eg. recommending specification and stability strategies, recommending novel analytical technologies based on product needs. Ensure that analytical methods developed by R&D are robust with respect to product lifecycle, focusing on the highest risk / most complex methods
• To lead and define comparability studies and suitable characterization strategies to support post approval changes for the accountable product/s. To compile and recommend acceptance criteria for release and stability tests to feed into the comparability strategies around TT process, change scale, material change. To provide analytical input and expertise into comparability protocols and summary reports for regulatory changes/documents and ensure Q&A follow-up during submission process.
• To partner with teams across the business in a matrix-fashion in order to meet asset analytical needs, and to identify and mitigate analytical risks i.e. with R&D Analytical, PCS (site and central), Technical (site and central), Regulatory
• To ensure that the analytical method knowledge is embedded in the onward Technical Transfer to other GSK sites and to external sites
• To drive PAT (Product Attribute Testing) and new technologies for analytical testing related to the Product control strategy
• To support sites by providing leadership and expertise for analytical aspects of root cause analysis investigations (RCA) in the frame of complex investigations related to the accountable product.
• To defend APS for the accountable product/s during HA inspections.
Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:
- BS 15+ years’
- Experience with analytical method development, validation and transfer
- Experience in the biopharmaceutical industry with relevant experience in late stage product, CQA assessment
- Strong understanding of drug substance and drug product dose forms manufacturing disciplines and relationship of analytical testing and control strategy.
If you have the following characteristics, it would be a plus:
- Ph.D. 10+ years’ experience, MS 12+ years’
- Experience authoring regulatory files (IND, IMPD, BLA, MAA, etc.
- Experience collaborating with third parties (CROs/CDMOs)
- Knowledge of PLM (product lifecycle) key aspects: technical risk assessment (TRA), product performance qualification (PPQ) and continued process verification (CPV).
- Knowledge and understanding of the statistics related to CPV, test method equivalence assessment, specification setting, stability studies evaluations, between others.
- Knowledge of basic risk assessment tools as FMEA to apply to required risk assessments: TRAs, MRAs, E&L risks assessments.
If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.
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.
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