Formulation Specialist

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 Review and analyse data, collaborating with the Strategy design team to prioritize product criticality and plan preformulation studies. Coordinate with the preformulation team to strategize reverse engineering studies for comprehensive characterization.
• You will be responsible to evaluate available information and consult with experts to devise contingency strategies, ensuring proactive identification of potential formulation development challenges during the strategy development phase.
• You will be responsible to strategize and oversee product development, ensuring timely milestone achievements and effective formulation experiments. Coordinate daily analysis plans with the Analytical team, proactively addressing potential challenges and ensuring resource availability. Facilitate pilot and exhibit batch processes, collaborate on process optimization trials, and contribute to PDR and filing preparation for the development of a robust and stable bioequivalent drug product.
• You will be responsible to perform and review experiment documentation as per company systems (ELN). Write Batch plans, protocols, sampling plans etc.
• You will be responsible to ensure robust regulatory strategy for drug products by preparing effective and comprehensive response to regulatory queries related to formulation development.
• You will be responsible to facilitate laboratory and equipment maintenance and implementation of company safety standards by Preparing and reviewing Standard Operating Procedure (SOP) pertaining to the function.
• You will be responsible to provide guidance to develop formulation capabilities within team.
  

Qualifications

Educational qualification:

• Experience in end-to-end product development and troubleshooting.
• Developed Oral Solid dosage forms and delivered 3-4 products overall for regulated markets.
• Good theoretical and practical understanding of different stages of formulation research and development
• Demonstrates theoretical knowledge of commonly used analytical evaluation and characterization tools.
• Basic understanding of engineering principles & process controls related to equipment and process scale ups.
• Knowledge of agency requirement like Food Drug Approval (FDA) guidelines; Current Good Manufacturing process (cGMP), Current Good Laboratory Practice (cGLP), Standard Operating Procedures (SOPs).
• Complete understanding on prerequisites of preclinical/clinical studies, sourcing, analytical data interpretation and regulatory aspects Intellectual Property (IP) laws and patents; developmental quality aspects.

Behavioral

• Excellent communication and interpersonal skills.
• Business Acumen & Decision Making
• Strong analytical and problem-solving abilities.
• Performance oriented and good at building, leveraging relationship.
• Ability to work collaboratively with own team and cross-functional teams.
• Committed to Learning & Coaching the team.
  

Additional Information

About the Department

Integrated Product Development Organisation

Benefits Offered