Business Introduction
We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance.
Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply.
We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.
Position Summary
You will lead extractables and leachables (E&L) quality activities across GSK’s network in India. You will provide scientific E&L guidance, perform toxicological assessments, and partner with cross-functional teams. You will ensure compliance with regulatory expectations and GSK quality standards. We value clear thinkers who communicate well, act with integrity, and want to grow while helping bring safe, reliable medicines to patients. This role offers learning, impact, and a chance to work at the intersection of science, technology and talent to get ahead of disease together.
Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
The job owner has a role of Quality Oversight of E&L documents supporting Large Molecules, Small Molecules and Vaccines divisions including related CMOs.
The job owner executes quality oversight review and approval of E&L risk assessments, Patient Exposure Scenario (PES) Doc, internal or external (third-party) protocols and reports, any technical documents linked to the E&L topic and all associated rationale/mitigation proposed.
The job owner will work with external laboratories for outsourced E&L protocols and reports (review and approval)
The job owner is responsible for ensuring adequate application of GMP and GDP practices including respect of the ALCOA+ principles and the review of the traceability and accuracy of data and rationale proposed.
The job owner has the task to ensure compliance with internal standards (GQP, GQSOP, GG etc.) and supportive document related to E&L strategy in support of E&L Global Subject Matter Experts.
The job owner support E&L Senior Global Quality Technical Leader to ensure appropriate and prompt risks escalation to the different parts of GSK.
The job owner has to ensure that documentation is aligned with the ALCOA+ principle and that data integrity is supported by adequate rationale and evidence.
The job owner has to support local quality representative to promote autonomy and performance in E&L practices.
The job owner has to support the expert community and participate in internal networks related to E&L.
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
Minimum: Advanced degree in chemistry, biology, chemical engineering or similar field of study
Preferred: Master's degree in Biochemistry, Chemical Engineering, or Bioengineering
Experience: at least 10-16 years of experience in pharmaceutical or biopharmaceutical Quality or a related field. A working experience of at least 3+ years in the field of E&L validation is required.
Strong technical and quality skills in E&L to support the review as for example Leachable Risk Assessment, Laboratory testing.
Collaborative mindset and ability to work across functions.
Resilience and adaptability in a dynamic environment.
Knowledge of relevant regulations and industry standards (GMP, WHO, PDA, EU, ICH, ASTM, ISPE, USP etc.).
Multicultural mindset skills
Teamwork ability skills
Prioritization skills
Execution & coordination skills in validation
Working knowledge of Microsoft Excel, including the use of formulas, filters, and basic data structuring for Risk Assessment templates, along with general proficiency in Word and PowerPoint for documentation and presentations, is required.
Preferred Qualification
If you have the following characteristics, it would be a plus:
Advanced degree (MSc or PhD) in toxicology, chemistry, pharmacy or related field.
5+ years’ experience specifically focused on extractables and leachable or related toxicology roles.
Experience using additional in silico tools or databases (OECD Toolbox, Helium, ToxPlanet, SciFinder or similar).
Experience supporting regulatory submissions and audits related to E&L topics.
Experience working with contract research organizations or external laboratories.
Comfortable working in a multicultural, matrixed organisation and mentoring junior colleagues.
What we offer
A chance to grow your scientific skills while making a clear impact on product safety and patient wellbeing. You will join teams who value open communication, learning and inclusion. We encourage you to apply even if you don’t meet every preferred point. If this role excites you, please submit your application and tell us how your skills can help us move science forward together. If you need adjustments during recruitment, contact our Recruitment Team at IN.recruitment-adjustments@gsk.com.
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.
Inclusion at GSK:
As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.
Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.
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