Location: Cambridge, MA
one or more key GSK products. The role will be responsible for leading and defining comparability studies and suitable analytical characterization strategies to support post-approval changes. The ASTL has ownership and accountability for the Analytical Product Strategy end to end taking accountability from the R&D Analytical Leader at PPQ Process Performance and Qualification stage.
Skills, Experience, Qualifications, If you have the right match for this opportunity, then make sure to apply today. 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. Lead and define comparability studies and suitable analytical characterization strategies to support post-approval changes for the accountable product/s.
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, PSC Analytical (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 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 analytical 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 backssment reports, if applicable To drive PAT and new technologies for analytical 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 analytical technologies based on product needs.
Ensure that analytical methods developed by R&D are robust with respect to product lifecycle, focussing on the highest risk / most complex methods To ensure that the analytical method knowledge is embedded in the onward Technical Transfer to other GSK sites and to external sites Support analytical and comparability aspects for the regulatory submission of accountable product. Eg. support authoring regulatory files and RTQs responses relevant to analytical and area of expertise. Provide leadership and expertise for all analytical aspects of root cause analysis investigations (RCA) related to the accountable product.
Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Ph. D. 10+ years', OR MS 12+ years', OR BS 15+ years' experience in biomedical/medical analytical Experience with large molecule and vaccines Preferred Qualifications: If you have the following characteristics, it would be a plus: Comprehensive knowledge of external regulatory requirements (MHRA, FDA), and internal/external quality and safety requirements. Experienced in technology transfer, with an understanding of the product development process Knowledge of current and emerging Regulatory Strategies (Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9, Q10) and Product Lifecycle Management.
Project management and prioritization skills gained within a complex matrix. Track record of improving products, processes and trouble-shooting, execution of technical activities including experimentation and analytical methods validation activitieinteractioncellent problem solver and ability to think and work creatively. Demonstrated experience leading technical aspects of root cause analysis investigations Demonstrated experience in the medical industry in leading the Technical aspects of Product Lifecycle Management related to large molecule products and/or vaccines (polysaccharide vaccines is an asset).
Demonstrated knowledge of Quality by Design and risk management approaches Strong technical acumen and communication skills with the ability to articulate complex, technical details to stakeholders and enable cross functional collaboration across sites, supply chain, R&D and CMO/CRO. Why GSK? 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 organization where people can thrive.
Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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. #LI-GSKPlease visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why Us? 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 organization where people can thrive.
Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. 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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy.
We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at -xyz X (US Toll Free) or xyz X (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, interaction, pregnancy, marital status, interactionual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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