Formulation Scientist

5 years

0 Lacs

Posted:14 hours ago| Platform: Linkedin logo

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Work Mode

On-site

Job Type

Full Time

Job Description

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

  • Identify the Project prerequisites and fill the identified gaps by working towards activities such as ensuring Import permissions availability, Providing License information to RA, Test/RLD samples procurement, additional data generation if any, Documentation including PDR rewriting, Stability protocols etc
  • Execute R&D experiments like dissolution discrimination and formulation and process optimization where necessary, Data analysis and Interpretation for PDR preparation for Brazil Market
  • You will be responsible to co-ordinate closely with analytical team to devise effective Proof of Concept (POC) for developing generic equivalent of Reference Listed Drug (RLD)/generic product. 
  • Post filing support like Technical evaluation during BE lot selection, Submission of samples for BE studies execution, PE/PQC samples availability for respective geographies, Deficiency response to CMC queries
  • You will be responsible for performing pre-formulation studies for material characterization, drug-excipient compatibility and Reference Listed Drug (RLD) characterization
  • You will be responsible to review data generated and participate in discussions with experts to conclude on prototype(s). Participate in strategizing the sourcing of Active Pharmaceutical Ingredient (API), raw materials and ensure development studies are performed related to regulatory and internal system requirements.

Qualifications

Educational qualification:

  • Have work experience on Formulation Development and expertise in Solid dosage form.
  • Experience in areas of product development for Generic product
  • Experience in formulation and process optimization
  • Knowledge on Good Manufacturing Practice and Good Laboratory Practice.
  • Should have good data analytical skills and technical report writing
  • Knowledge on general regulatory requirement , selected person will be provided with know-how on regulatory requirements for Brazil Market
  • Should have fair understanding on bio equivalence studies

Behavioral

  • Excellent communication and interpersonal skills.
  • Strong analytical and problem-solving abilities.
  • Ability to work collaboratively with own team and cross-functional teams.

Additional Information

About the Department

Integrated Product Development Organisation

Benefits Offered

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