Analytical Science and Technology Lead (ASTL) Small Molecule
Analytical Science and Technology Lead (ASTL) Small Molecule

Analytical Science and Technology Lead (ASTL) Small Molecule

Barnard Castle Full-Time 48000 - 72000 Β£ / year (est.) No home office possible
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At a Glance

  • Tasks: Lead analytical strategies for key GSK products and manage comparability studies.
  • Company: GSK is a global biopharma company focused on innovative medicines and vaccines.
  • Benefits: Enjoy competitive salary, bonuses, training opportunities, and healthcare programmes.
  • Why this job: Join a mission-driven team impacting global health and thrive in an ambitious culture.
  • Qualifications: Degree in a scientific discipline with experience in drug manufacturing and regulatory submissions.
  • Other info: Flexible working culture and commitment to diversity and inclusion.

The predicted salary is between 48000 - 72000 Β£ per year.

Overview

The Analytical and Materials Science Function is a global team supporting GSK’s new product introduction into the market and manufacturing sites with projects aligned to technology transfers, material changes and rapid resolution of RCAs associated with business-critical supply issues.

Job Purpose

The ASTL supports the delivery of business-critical projects with the provision of expertise linked to all aspects of the late-phase of the product lifecycle (PhIII/PPQ/Commercial) for key GSK products. The ASTL is accountable for one or more small molecule key GSK products.

The ASTL has accountability for the analytical control strategy (ACS) – end to end – taking accountability from the R&D team at commercial launch. The role manages and defines appropriate comparability studies and suitable characterization strategies to support post-approval changes.

Key Responsibilities

  • Provide technical expertise 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, post-approval changes, regulatory submissions.
  • Own and be accountable for the Analytical control strategy (ACS). Maintain and update the ACS through the post-approval product lifecycle eg. recommending specification strategy, recommending novel technologies based on product needs. Ensure that method developed for NPI are robust with respect to commercial product lifecycle, focusing on the highest risk / most complex methods
  • Manage and define comparability studies and suitable characterization strategies to support post-approval changes for the accountable product/s. Provide input and expertise into comparability protocols and summary reports for regulatory changes/documents.
  • 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), Regulatory.
  • Ensure that method knowledge is embedded in the onward Technical Transfer to other GSK sites (and to external sites).

Drive evaluation of new technologies for analytical testing related to the control strategy.

  • Support sites by providing leadership and expertise for analytical aspects in the frame of complex investigations related to the accountable product.
  • Represent ACS for the accountable product/s during audits and inspections.

Location

The successful applicant can be based at any GSK UK-based site (preferably a manufacturing supply chain site) or in the USA at the Rockville, Upper Merion or Upper Providence site(s).

About You

This role would suit a highly motivated person who has strong 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 in order to manage comparability studies and other key activities (to support product life cycle). 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: Monday 8th of September 2025 (COB).

Qualifications

Basic Qualifications / Experience:

  • Relevant experience and qualifications (eg; BS in a scientific discipline -pharmacy, chemistry, biology, biochemistry, or related technical discipline).
  • 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).

Benefits

GSK offers a range of benefits to its employees, which include, but are not limited to:

  • Competitive base Salary
  • Annual bonus based on company performance
  • Opportunities to partake in on the job training courses
  • Opportunities to attend and partake in industry conferences
  • Opportunities for support for professional development
  • Access to healthcare and wellbeing programmes
  • Employee recognition programmes

If you would like to learn more about our company wide benefits and life at GSK we would suggest looking at our webpage Life at GSK | GSK.

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 on UKRecruitment.Adjustments@gsk.com or 0808 234 4391. The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary.

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 UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK\’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/

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Analytical Science and Technology Lead (ASTL) Small Molecule employer: Gsk

GSK is an exceptional employer that fosters a culture of innovation and collaboration, making it an ideal place for professionals in the Analytical Science and Technology field. With competitive salaries, annual bonuses, and extensive opportunities for professional development, employees are empowered to thrive in their careers while contributing to meaningful advancements in healthcare. The company's commitment to employee wellbeing and its agile working culture further enhance the work environment, particularly at its UK-based manufacturing sites where impactful projects are at the forefront of biopharmaceutical development.
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Contact Detail:

Gsk Recruiting Team

StudySmarter Expert Advice 🀫

We think this is how you could land Analytical Science and Technology Lead (ASTL) Small Molecule

✨Tip Number 1

Familiarise yourself with GSK's product lifecycle, especially the late-phase processes like PhIII and PPQ. Understanding these phases will help you demonstrate your expertise during discussions and interviews.

✨Tip Number 2

Network with professionals in the pharmaceutical industry, particularly those who have experience in analytical control strategies. Engaging with them can provide insights into the role and may even lead to referrals.

✨Tip Number 3

Stay updated on the latest technologies and methodologies in analytical testing. Being knowledgeable about novel approaches can set you apart as a candidate who is proactive and innovative.

✨Tip Number 4

Prepare to discuss your experience with regulatory submissions and comparability studies. Highlighting specific examples of your past work in these areas will showcase your suitability for the role.

We think you need these skills to ace Analytical Science and Technology Lead (ASTL) Small Molecule

Analytical Control Strategy (ACS) Management
Comparability Studies Design
Regulatory Submission Expertise
Technical Risk Assessment (TRA)
Product Performance Qualification (PPQ)
Continued Process Verification (CPV)
Method Development for NPI
Statistical Analysis for Test Method Equivalence
Strong Stakeholder Management
Cross-Functional Collaboration
Scientific Knowledge in Small Molecules
Leadership in Complex Investigations
Robust Problem-Solving Skills
Continuous Improvement Mindset

Some tips for your application 🫑

Tailor Your CV: Make sure your CV highlights relevant experience and qualifications that align with the Analytical Science and Technology Lead role. Focus on your expertise in small molecules, analytical control strategies, and any experience with regulatory submissions.

Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the role and the company. Mention specific projects or experiences that demonstrate your ability to manage comparability studies and your understanding of the product lifecycle.

Highlight Technical Skills: In your application, emphasise your technical skills related to drug substance and product dose forms manufacturing. Include any experience you have with statistical methods relevant to CPV and specification setting.

Showcase Stakeholder Management: Provide examples of how you've successfully collaborated with cross-functional teams in previous roles. This is crucial for the ASTL position, as it requires strong stakeholder management skills to meet asset needs and mitigate risks.

How to prepare for a job interview at Gsk

✨Understand the Analytical Control Strategy

Make sure you have a solid grasp of the Analytical Control Strategy (ACS) and its importance in the product lifecycle. Be prepared to discuss how you would maintain and update the ACS, especially in relation to post-approval changes.

✨Showcase Your Technical Expertise

Highlight your experience with small molecules and your understanding of drug substance and product dose forms. Be ready to provide examples of how you've applied your technical knowledge in previous roles, particularly in managing comparability studies.

✨Demonstrate Stakeholder Management Skills

Since this role involves partnering with various teams, be prepared to discuss your experience in cross-functional collaboration. Share specific instances where you've successfully managed stakeholder expectations and driven projects forward.

✨Prepare for Regulatory Discussions

Familiarise yourself with the regulatory files you may encounter, such as IND, IMPD, BLA, and MAA. Be ready to discuss your experience in authoring these documents and how you ensure compliance during audits and inspections.

Analytical Science and Technology Lead (ASTL) Small Molecule
Gsk

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  • Analytical Science and Technology Lead (ASTL) Small Molecule

    Barnard Castle
    Full-Time
    48000 - 72000 Β£ / year (est.)

    Application deadline: 2027-09-09

  • G

    Gsk

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