Senior Scientist - Extractables & Leachables (E&L)

Why This Role Matters

The Senior Scientist – Extractables & Leachables (E&L) plays a critical role in ensuring product safety, regulatory compliance, and quality assurance within pharmaceutical and biopharmaceutical development. This position supports the identification, assessment, and control of potential chemical contaminants that may migrate from packaging or manufacturing systems into drug products.
By leveraging scientific expertise in chemistry and life sciences, the role ensures that testing strategies, protocols, and compliance standards meet global regulatory expectations. The position directly contributes to safeguarding patient health and maintaining high standards of GMP/GDP compliance across product lifecycles.

Job Description

The Senior Scientist – E&L will be responsible for supporting Extractables & Leachables studies, protocol development, laboratory coordination, and regulatory documentation. The role requires strong theoretical and technical expertise in chemistry, biotechnology, or related life science disciplines.
The job holder will contribute to technical compliance activities, laboratory investigations, and process understanding in alignment with global regulatory frameworks. This role demands analytical rigor, scientific documentation skills, and the ability to collaborate with cross-functional teams in R&D, Quality, and Manufacturing.

Key Features of the Role:

• Focus Area: Extractables & Leachables (E&L)
• Function: Analytical Science / Technical Compliance
• Industry: Biopharmaceutical / Life Sciences
• Involvement in protocol writing and laboratory testing
• Strong exposure to GMP/GDP regulated environments
• Cross-functional collaboration with quality and manufacturing teams

Responsibilities

• Design and support Extractables & Leachables (E&L) studies
• Develop and review study protocols and technical documentation
• Ensure compliance with GMP/GDP standards and regulatory expectations
• Interpret laboratory data and prepare structured scientific reports
• Support risk assessments related to packaging and manufacturing systems
• Collaborate with Quality, Manufacturing, and Regulatory Affairs teams
• Maintain technical documentation aligned with global compliance requirements
• Contribute to process understanding and product lifecycle management

Required Qualifications

Candidates must demonstrate strong academic grounding and technical expertise in chemistry or life sciences.

Educational Requirements:

Minimum Advanced Degree in one of the following disciplines:
• M.Sc
• M.Tech
• M. Pharma
(With specialization in Chemistry, Life Sciences, Biotechnology, Biochemical Engineering, Chemical Engineering, or Pharmacy)

Area of Specialisation:

• Chemistry
• Life Sciences / Biotechnology
• Biochemical / Chemical Engineering
• Pharmacy

Why This Level of Education is Required

The advanced educational background ensures the candidate possesses the theoretical and technical knowledge required for:
• Extractables & Leachables (E&L) assessments
• Protocol writing and structured laboratory testing
• Understanding of GMP/GDP technical compliance
• Process science and regulatory framework alignment

Experience and Skills:

• Strong foundation in analytical chemistry and life sciences
• Experience in protocol writing and technical documentation
• Understanding of GMP/GDP regulations
• Knowledge of pharmaceutical manufacturing processes
• Strong analytical and problem-solving skills
• Ability to interpret complex laboratory data
• Effective communication and cross-functional collaboration skills
• High attention to detail and compliance mindset

Salary Insights

Compensation will align with industry standards for senior-level scientific roles within the biopharmaceutical sector. Salary may vary depending on experience, technical expertise, and regulatory exposure.

Company Overview

GSK (GlaxoSmithKline) is a global biopharmaceutical company dedicated to uniting science, technology, and talent to get ahead of disease together. The company focuses on preventing and treating disease through innovation in specialty medicines and vaccines.
GSK operates across key therapeutic areas including respiratory, immunology and inflammation, oncology, HIV, and infectious diseases. The organization aims to positively impact the health of billions worldwide while fostering a culture that encourages ambition for patients, accountability for impact, and ethical responsibility.

FAQs

Q1. Is prior E&L experience mandatory?
Experience in analytical chemistry and regulatory compliance is highly preferred, especially in E&L studies.

Q2. What type of industry exposure is expected?
Biopharmaceutical, pharmaceutical, or regulated life science industry exposure is ideal.

Q3. Is this role laboratory-based?
Yes, it involves laboratory testing oversight along with protocol development and compliance documentation.

Q4. Are fresh graduates eligible?
Typically, advanced scientific roles require relevant experience along with the required educational background.

Application Tip

• Highlight experience in E&L studies and protocol writing
• Mention GMP/GDP compliance exposure clearly
• Include technical tools and analytical instrumentation expertise
• Showcase regulatory documentation experience
• Emphasize cross-functional collaboration in regulated environments