Process Engineering Specialist

2 weeks ago


Hyderabad, Telangana, India Dr Reddys Full time US$ 1,50,000 - US$ 2,00,000 per year

Job Summary

We are seeking a dynamic and experienced Specialist in Process Engineering in Active Pharmaceutical Ingredient (API) development with proven expertise in scaling up or down technologies to meet production demands. Proficient in Process and Chemical Engineering, adept at troubleshooting complex projects, facilitating technology transfer, and optimizing operations. Demonstrated experience in unit operations including crystallization, filtration, drying, and size reduction, with a strong commitment to quality and regulatory compliance.

Roles & Responsibilities

  • 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.

Qualification

Educational qualification: B.tech in Chemical engineering

Minimum work experience: 7 years of experience in Process development & scale up of at least 6-8 products.

Skills & attributes:

Technical Skills

  • 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

We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages

Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years.

Benefits Offered

At Dr. Reddy's we actively help to catalyse your career growth and professional development through personalised learning programs.

The benefits you will enjoy at Dr. Reddy's are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.

Our Work Culture

Ask any employee at Dr. Reddy's why they come to work every day and they'll say, because Good Health Can't Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we're always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.

For more details, please visit our career website



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