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Analytical Science

4 months ago


Cambridge, Massachusetts, United States GlaxoSmithKline Full time
Site Name: Cambridge Binney Street
Posted Date: May

GSK is currently looking for an Analytical Science & Technology Leader in Cambridge, MA. This role is responsible for the leadership and delivery of business-critical projects to support all the analytical aspects related to 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 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.

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 assessment 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. Degree with 6+ years', OR MS Degree with 8+ years', OR BS Degree with 10+ years' experience in biopharmaceutical/pharmaceutical 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 activities
  • Excellent problem solver and ability to think and work creatively.
  • Demonstrated experience leading technical aspects of root cause analysis investigations
  • Demonstrated experience in the Pharmaceutical 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-GSK

Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees.

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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