Role Overview
The Associate Scientist role at Lupin is focused on research and development of sterile pharmaceutical products, including complex injectable formulations. The position supports product-development activities from scientific literature review and idea generation through formulation strategy, raw-material selection, pre-formulation studies, process development, stability evaluation, technology transfer and regulatory-market submission support.
Core Responsibilities
Conduct scientific literature searches to identify relevant technical, formulation, product-development and regulatory information.
Generate development ideas based on scientific findings and product requirements.
Prepare detailed technical reports documenting research, development activities, observations and conclusions.
Develop product-development strategies for a variety of sterile drug products.
Incorporate technical, intellectual-property, regulatory and clinical requirements into product-development planning.
Support development and optimization of complex injectable products.
Screen and select appropriate raw materials for pharmaceutical product development.
Evaluate and select active pharmaceutical ingredients (APIs), excipients and packaging components.
Conduct pre-formulation studies to understand material characteristics and their impact on product development.
Perform solution chemistry studies relevant to sterile and injectable formulations.
Participate in process-development activities for pharmaceutical products.
Optimize development and manufacturing processes for complex injectable products.
Support stability evaluation and assess product performance during development.
Apply Quality by Design (QbD) principles where applicable during pharmaceutical product development.
Perform basic physico-chemical testing and interpret results to support formulation and process decisions.
Handle technology-transfer batches and support transfer of developed processes into subsequent manufacturing or development stages.
Support activities associated with product submissions in regulated markets.
Maintain appropriate technical documentation throughout research and product-development activities.
Technical & Domain Expertise
Understanding of sterile pharmaceutical product development.
Knowledge of complex injectable formulation and process development.
Scientific literature-search capability and technical report preparation.
Product-development strategy preparation.
Understanding of intellectual-property considerations in pharmaceutical development.
Knowledge of regulatory and clinical requirements affecting product-development strategy.
Raw-material screening and selection involving APIs, excipients and packaging components.
Pre-formulation studies and solution chemistry.
Process development and process optimization.
Application of Quality by Design principles.
Basic physico-chemical testing.
Understanding of the regulatory framework for pharmaceutical product development and filing.
Familiarity with International Council for Harmonisation (ICH) requirements and expectations of regulated markets.
Exposure to technology-transfer activities and batches.
Understanding of regulated-market product-submission requirements.
Quality, Compliance & Laboratory Standards
Follow Good Documentation Practices (GDP) during research and development work.
Follow current Good Manufacturing Practices (cGMP) requirements where applicable.
Follow Good Laboratory Practices (GLP).
Maintain laboratory safety practices during all assigned activities.
Support compliant generation, documentation and handling of scientific and technical data.
Ensure development activities are conducted with attention to applicable regulatory and quality requirements.
Professional & Functional Expectations
Demonstrate the ability to manage multiple activities and priorities.
Apply analytical thinking and an out-of-the-box approach to scientific and development challenges.
Communicate effectively with internal teams through strong verbal communication.
Prepare clear and effective written technical documentation and reports.
Demonstrate good interpersonal skills while working with cross-functional research, development, analytical, regulatory and technology-transfer teams.
Education & Experience
Doctorate in Pharmaceutical Technology or Polymers.
PhD with approximately 2-3 years of relevant work experience.
Business & Scientific Impact
The role contributes directly to development strategies for sterile pharmaceutical products and complex injectables. The Associate Scientist supports scientific decision-making across formulation development, process optimization, stability, regulatory readiness and technology transfer, helping advance products toward submission and commercialization in regulated markets.
Benefits & Total Rewards
The provided job posting does not disclose a specific salary range, bonus structure, insurance coverage or other employee benefits. Candidates should confirm the role-specific compensation structure and total-rewards package directly during the official Lupin recruitment process.