Job Title: Analytical Expert – Extractable & Leachable (E&L) Studies
Department: Integrated Product Development Organization (IPDO)
Location: [Specify location if known, e.g., Hyderabad, India]
Job Type: Full-time | On-site | Analytical Research & Development
Experience Level: 15–20 years
Job Summary
We are seeking a dynamic and highly experienced Analytical Expert specializing in Extractable and Leachable (E&L) studies to lead method development, validation, and batch analysis across multiple analytical platforms. The role involves guiding a team to execute E&L studies with regulatory compliance, ensuring robust analytical strategies for ANDA and DMF filings. You will collaborate with AR&D leadership to implement innovative process improvements and integrate new analytical technologies for future-ready product development.
Key Roles & Responsibilities
1. Technical Leadership & Analytical Expertise
Lead method development and validation activities for E&L studies, ensuring scientific rigor and regulatory alignment.
Provide expert guidance on analytical techniques including GC-MS, LC-MS, ICP-MS, and IC for method design, troubleshooting, and data interpretation.
Review and approve technical reports, risk assessments, and leachable screening results to ensure data integrity and compliance.
Oversee analytical responses to formulation-related queries from regulatory authorities and customers.
Anticipate and address potential regulatory challenges proactively.
2. Innovation & Process Optimization
Evaluate, recommend, and implement new technologies to enhance analytical performance and compliance.
Develop proof-of-concept studies to validate new analytical tools and methodologies.
Collaborate with internal and external partners to streamline analytical workflows and improve efficiency.
3. Regulatory & Compliance
Ensure all E&L studies adhere to global regulatory standards (e.g., ICH Q3D) and internal quality systems.
Oversee documentation, validation reports, and method transfer protocols to maintain readiness for audits and filings.
Support product submissions under ANDA and DMF frameworks with scientifically sound analytical justifications.
4. Team Development & Mentorship
Mentor and coach AR&D scientists to enhance their technical proficiency and analytical capabilities.
Conduct periodic training sessions to strengthen the team’s expertise in E&L methodologies and regulatory standards.
Design and implement personalized development plans to build a high-performing analytical team.
Qualifications
Education:
Master’s or Ph.D. in Pharmaceutical Sciences or related field.
Experience:
15–20 years of experience in Analytical Research & Development (AR&D) with strong expertise in Extractable, Leachable, and Elemental Analysis.
Skills & Attributes
Technical Skills
Proven expertise in Extractable, Leachable, and Elemental Impurity testing.
Deep understanding of ICH Q3D guidelines and global regulatory expectations.
Hands-on experience with GC, HPLC, LC-MS, GC-MS, ICP-MS, and IC techniques.
Skilled in analytical method development, validation, transfer, and investigations.
Strong understanding of material chemistry and its application in formulation analysis.
Behavioral Skills
Strong leadership and mentoring abilities.
Excellent communication and interpersonal skills.
Strategic thinking with sound decision-making and business acumen.
Ability to work collaboratively across functions and drive complex projects.
Analytical and problem-solving mindset with focus on continuous improvement.
About the Department – Integrated Product Development Organization (IPDO)
Dr. Reddy’s IPDO integrates deep scientific expertise with cutting-edge technology to develop innovative, affordable, and accessible therapies for patients worldwide. Our end-to-end capabilities span APIs, formulations, clinical research, IP, and regulatory affairs.
We serve over 55 global markets, including the USA, Europe, LATAM, China, and ASEAN, with a robust portfolio of 1,000+ products and 1,071 filed patents. Supported by over 200 scientists and 150 doctorates, our R&D excellence drives global innovation and scientific advancement.
Benefits Offered
Competitive compensation and benefits in line with industry standards.
Joining and relocation support.
Family support programs (Maternity & Paternity benefits).
Comprehensive medical and life coverage for employees and dependents.
Learning and development programs to support professional growth.
Our Work Culture
At Dr. Reddy’s, our purpose is clear — “Good Health Can’t Wait.”
We view healthcare not just as formulations, but as pathways to healthier lives. Our culture is rooted in empathy, collaboration, and innovation, empowering our people to make meaningful impact every day. We foster an environment that values teamwork, personal growth, and shared success — where diverse minds unite with a common purpose to create real change.
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