Expert Characterization Technique

Good Health Can't Wait

We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.

For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity to strengthen our core further (the next steps) and to build the future (the new bets).

The Next and the New is how we aim to continue to be the partner of choice purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency

Dr Reddy's maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.

Job Summary

• You will be responsible to lead team in method development and validation for E&L studies.
• Provide expertise in designing of methods, troubleshooting and data interpretation for GC-MS, LC-MS, ICP-MS and IC techniques.
• Guide preparation of technical reports and risk assessments, oversee leachable screening on various analytical platforms, and ensure alignment with business goals for robust and quality-driven product development
• You will be responsible to oversee formulation-related queries from regulatory authorities and customers, guiding teams in addressing deficiencies in all the techniques used. Proactively anticipate potential concerns, offering timely measures to address regulatory queries effectively.
• You will be responsible to assess and implement new technologies for project applications and regulatory compliance, developing proof of concept with expert support and fostering external collaborations. Evaluate technologies for streamlining existing methods, ensuring faster analysis and results to prepare the organization for future product portfolio challenges.
• You will be responsible to mentor and offer technical guidance to the Analytical Research & Development team, conducting periodic training to enhance their skills and performance. Implement tailored technical development plans to enrich the team's capabilities and expertise.
  

Qualifications

Educational qualification:

• Experience in Extractable, leachable and elemental analysis.
• Knowledge on Extractable, leachable, The International Council for Harmonization (ICH) Q3D guidelines.
• Understanding and experience on Gas chromatography (GC) or high-performance liquid chromatography (HPLC) method development and method validations.
• Experience in analytical method development / validations / transfers/ investigations, sameness studies for elemental analysis.
• Expertise on High-end techniques like LC-MS, GC-MS, ICP-MS and IC techniques
• Displays understanding of physical & chemical properties of materials used in formulations and applications.

Behavioral Skills

• Excellent communication and interpersonal skills.
• Business Acumen and Good decision making skills.
• Ability to work with cross functional teams.
• Strong analytical and problem-solving abilities.
• Leadership skills to motivate and mentor the team.
  

Additional Information

About the Department

Integrated Product Development Organisation

Benefits Offered