Process Engineering Specialist Active Pharmaceutical Ingredient API

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 Scaleup 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 scaleup 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 coordination with Cross Functional Teams.
• You will be responsible for Technology Transfer & Scaleup 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. 
• You will be responsible for generation of technical data/conclusion through usage of mathematical modelling softwares like MATLAB MixIT and Dynochem softwares

Qualifications :

Educational qualification: B.tech or M.Tech. in Chemical engineering from reputed institute

Minimum work experience: 7 years of experience in Process development & scale up mathematical modelling and simulation of at least 68 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 Scaleup 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 problemsolving abilities.
• Ability to work collaboratively with own team and crossfunctional teams. 

Additional Information :

About the Department

Integrated Product Development Organisation                                         

We integrate our deep science capabilities and cuttingedge technology to develop innovative accessible and affordable therapies for patients worldwide. We are a sciencedriven innovationfocused 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 1000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates we have filed 1071 patents and also published over 1000 papers for peer review over the years.

Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys 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. Reddys why they come to work every day and theyll say because Good Health Cant 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 were 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 at !/ 

Remote Work :

No

Employment Type :

Fulltime