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

We are seeking a dynamic and experienced Formulation Scientist in Product development, technical due diligence of dossiers of multiple dosage forms for India Market. Expertise in oral solid dosage forms and sound knowledge in trouble shooting of process scale up challenges. Collaborating across functions of Portfolio, Marketing, Medical affairs and External partners.

Roles & Responsibilities

• You will be responsible to drive the new product launch. Create a comprehensive plan with clear objectives and targets for the technical diligence process, fostering strong relationships with stakeholders through regular communication and trust-building. Encourage cross-functional collaboration, manage risks, adhere to regulatory standards, and monitor progress closely to ensure timely delivery of the product and continuously improving the process.
• You will be responsible to coordinate with cross-functional teams for Technical Diligence discussions and closure activities, including Pre Apex, Apex,
• Review product document evaluation / support team in resolving the issues, provide support to prepare and finalize the gap report, Discuss the identified gaps during due diligence with partner and hand hold for gap closures, coordinate with partner for batches execution for composition / process improvements as required, Generation of required data at partner end or outside laboratories, closure of action items

  
  

  In order to expedite product due diligence and sharing gap report with partners and on time gap closure for product clearance
  

• You will be responsible for providing immediate support on need basis for addressing the Organisation priorities such as Global Manufacturing Process Robustness/ Oncology Portfolio Support for India.
• You will be responsible for providing expert formulation knowledge considering the consumer insights, product understandings in design and delivering the consumer delighted products with better business gross margins.
• You will be responsible for Regulatory and Compliance support and drafting technical justification responses to the Chemistry, Manufacturing, and Controls (CMC) sections of product development queries/deficiencies notified by regulatory agencies.
• You will be responsible for knowledge sharing and providing guidance, including technical, to team members to develop formulation capabilities within teams.
• You will be responsible for conducting literature reviews and staying abreast of the latest developments in formulation science, ensuring that the organisation remains at the forefront of innovation in drug delivery systems.
• You will be accountable for developing and maintaining Standard Operating Procedures (SOPs) for formulation processes, ensuring consistency and quality across all product development activities.
• You will be tasked with participating in technology transfer activities, facilitating smooth transitions from research and development to commercial manufacturing, and providing technical support during scale-up processes.

Qualifications

Educational qualification:

• Experience in Formulations & Development, Integrated Drug development
• Experience in the Product development process in Research & Development, Regulatory & Compliance
• Understanding of Different Markets (India & Brazil)
• Understanding of Regulatory & Compliance requirement across geography (For Global Products).
• Experience in Biopharmaceutics, Pharmacokinetics and Documentation
• Understanding of Intellectual Property (IP) laws and patents.

Behavioral

• Excellent communication and interpersonal skills.
• Effective planning and high level of performance orientation.
• Strong Strategic thinking ability, analytical and problem-solving abilities.
• Good at networking, well developed influencing & assertiveness skills
  

Additional Information

About the Department

Integrated Product Development Organisation

Benefits Offered