Analytical Science & Technology Lead (ASTL) - Small Molecule

1054 GlaxoSmithKline Services Unlimited; Ware; On-site; GBP 120,000 - 150,000; Full time

Job summary

GlaxoSmithKline plc in the UK is seeking an Analytical Science and Technology Lead (ASTL) to drive end-to-end analytical strategy for late-stage product lifecycle. You will lead comparability studies, method transfers and critical investigations impacting regulatory submissions and market supply.

The role requires strong leadership, cross-functional collaboration across R&D, manufacturing and QA, and a track record in applying innovative analytical technologies to complex processes.

Qualifications

• BS/MS in a scientific discipline (pharmacy, chemistry, biology or related field).
• Experience with analytical method development, validation and transfer.
• Experience in biopharmaceutical late-stage product and CQAs.

Responsibilities

• Provide analytical leadership for programs, projects and activities to meet priorities such as NPI, product transfers, change management and regulatory submissions.
• Define and maintain comparability studies and acceptance criteria for release and stability tests.
• Input to comparability protocols and regulatory documents, considering non-routine data and regulatory expectations.
• Partner with R&D, manufacturing, regulatory and QA teams in a matrix to meet asset needs and mitigate risks.
• Drive evaluation of new analytical technologies, including PAT, for product control strategy.
• Support sites with analytical aspects of RCA investigations in complex post-approval investigations.
• Defend APS during HA inspections and regulatory reviews.

Skills

CMC Strategy

Data-Driven Decision Making

Data Integrity

Debate Moderation

Digital Fluency

GxP Regulations

Lean Management

Problem Solving

Process Optimization

Project Leadership

Risk Awareness

Scientific Writing

Technology Transfer

Education

BS/MS in a scientific discipline (pharmacy, chemistry, biology or related field)

Job description

The Manufacturing Science and Technology (MSAT) Analytical Science Function is a global team supporting GSK’s new product introduction into the market and manufacturing sites with projects aligned to technology transfers, second generation processes and critical investigations with supply impact.

Job Purpose: The Analytical Science and Technology Lead (ASTL) 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 for key GSK products. The ASTL is accountable for several key GSK products. The role is responsible for managing and defining comparability studies and suitable characterisation strategies to support post-approval changes. The ASTL has end-to-end ownership for the Analytical Product Strategy, taking accountability from the R&D Analytical Leader at first wave approval.

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 e.g. 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 manage 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 reports, taking into account non-routine physical properties data and recommendations from Materials Science 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 needs, and to identify and mitigate risks i.e. with R&D, GSC (site and central), Technical (site and central), and Regulatory
• To ensure that the method knowledge is embedded in the onward Technical Transfer to other GSK sites and to external sites
• To drive evaluation of new technologies, including PAT, for analytical testing related to the Product control strategy
• To support sites by providing 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.

Location

The successful applicant can be based at Ware (UK) manufacturing site or at Upper Merion (USA) site.

About You

This role would suit a highly motivated person with strong leadership and 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 (eg; small molecule) and experience to support new products introduction or complex life cycle investigations. 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.

CLOSING DATE for applications: Friday 20th of November 2026 (COB).

Basic Qualifications / Experience

• Relevant education / qualifications (eg; BS/MS in a scientific discipline - pharmacy, chemistry, biology, biochemistry, or related technical discipline).
• Experience with analytical method development, validation and transfer.
• Experience in the biopharmaceutical industry with relevant experience in late‑stage product, Critical Quality Attribute (CQA) assessment.
• Strong understanding of drug substance and drug product dose forms manufacturing disciplines and relationship with analytical testing and control strategy.
• Experience authoring regulatory files (IND, IMPD, BLA, MAA, etc.).

Preferred Qualifications / Experience

• Knowledge and understanding of the statistics related to CPV, test method equivalence assessment, specification setting, stability studies evaluations, between others.
• Knowledge of product lifecycle key aspects: technical risk assessment (TRA), product performance qualification (PPQ) and continued process verification (CPV).

Skills

CMC Strategy, Data-Driven Decision Making, Data Integrity, Debate Moderation, Digital Fluency, GxP Regulations, Lean Management, Problem Solving, Process Optimization, Project Leadership, Risk Awareness, Scientific Writing, Technology Transfer.

Why GSK?

Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. 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. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at [e-mail] where you can also request a call. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive.

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We are 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. 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. Find out more on our career site.