Process Engineer API

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.

Function: Other
Experience Level: Mid-Senior Level