Global Analytical Methods Lifecycle Specialist

We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 1.7 billion packs of medicine and 767 vaccine doses in 2021.

We continue to modernize, so we can launch even more new products at speed whilst turbo-charging delivery across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of automation and robotics so we can work smarter together.
 

As a Global Analytical Methods Lifecycle Specialist, you will be responsible for providing GMP analytical support for GSK products from PPQ through commercial launch and supply. This includes providing technical input and support on analytical methods validation, robustness and readiness for commercial filing and transfer  from PPQ phase for both internal and external supply chains.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• Provide SME support for methods, analytical validation, and troubleshooting methods.
• Responsible for the generation of release and stability global methods and global specifications for products tested at multi-site locations.
• Ensure analytical method validation, robustness, and readiness for transfer to GSK cGMP laboratories, and contract testing laboratories.
• . Author templates, guidelines, SOPs, or project plans.
• Responsible for providing input on analytical method strategy from phase 3 onwards..
• Routinely review analytical methods regarding their validation status and capability.
• Provide technical oversight for third party data, methods, and deviations.
• Responsible for supporting andauthoringrelevant CMC modules and responses to regulatory questions for commercial and post-commercial regulatory submissions.
• Support routine regulatory inspections and pre-approval inspections for GSK assets.

Why you?

Basic Qualifications:

We are looking for professionals with the required skills to achieve our goals:

• Bachelor’s degree in biotechnology, Chemistry or Biology
• 6+ years Parma QC experience
• 5+ years GMP experience
• 6+ years Biopharm methods hands on experience

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• MS or PhD
• Method Validation
• Strong knowledge of cGMP and regulatory requirements for the development and commercialization of products.
• Well versed in analytical method readiness, robustness, and method validation.
• Excellent written/verbal communication, presentation and effective influencing skills.
• Demonstrated competency in project management.
• Effectively coordinates external collaborations with 3rd parties
• Familiarity with FDA/EU/ICH regulations and guidance particularly as they relate to Analytical Testing.
• familiarity with change management tools.
• Strong experience in writing regulatory submissions and responding to questions and supporting regulatory inspections.
• Represent GQC in internal project meetings.

Please visit  GSK US Benefits Summary to 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 sharehold