Process Engineering Specialist

7 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

  • You will be responsible for development and Scale-up of processes for new products, Technology Transfer & Process Validation of the product at plant scale.
  • You will be responsible to work in collaboration with Chemistry team & provide necessary inputs during Design of Experiments (DoE) studies & further process optimization.
  • You will be responsible to develop detailed process understanding & ensure scale-up feasibility using fundamental studies of reaction kinetics, Crystallization, Process Safety, Process analytical technology (PAT).
  • You will be responsible to ensure appropriate facility/equipment/technology mapping at in house/SBP plants.
  • You will be responsible to draft the process for scale up i.e Kilo lab, Critical Process Parameter (CPP) and validation batches in co-ordination with Cross Functional Teams.  
  • You will be responsible for Technology Transfer & Scale-up of Active Pharmaceutical Ingredient (API) and engineering optimization studies with minimal guidance
  • You will be responsible for supporting Drug Master Filing (DMF), address regulatory queries related to process engineering, and demonstrate awareness of process validation, GMP, and GLP aspects to facilitate smooth regulatory filing.
  • Your role will involve staying familiar with the Intellectual property (IP) landscape and relevant literature, participate in industry forums, and disseminate knowledge within PE teams, applying existing knowledge and technologies during development.
  • You will be responsible for proactive planning & timely completion of Process Engineering tasks in alignment with project goals.
  • You will be working collaboratively in cross functional team to drive Process Engineering activities.
  • You will be responsible to Provide technical & execution guidance to new members in Process Engineering team. 

Qualifications

Educational qualification:

  • Have work experience on Process scale up of Active Pharmaceutical Ingredients.
  • Knowledge of core chemical engineering like Heat & mass transfer, reaction engineering, fluid dynamics, separation technologies etc. for process optimization & scale up 
  • Experience in Operational Excellence, Scale-up process.
  • Knowledge of product Development, basic understanding of Chemistry, analytical, RA and IP 
  • Experience in Technology Transfer 
  • Should be well versed with Current Good Manufacturing Practice (CGMP) practices & quality systems in Pharma industry
  • Familiarity with tools for engineering optimization like Design of Engineering (DoE), dynochem.

Behavioral Skills

  • 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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