To work on process development and synthesis of organic compounds.
Key Responsibilities :
Involvement in preparing the cost sheets for new RFP’s
Performing experiments by focusing robust process, scale up studies, engineering studies etc. to ensure the process is robust enough to scale up
Noticing criticality of the experiments and provide valuable feedback to improve the process in-order to avoiding the batch failure
Optimizing the chemical processes in terms of safety, robustness, and reproducibility to synthesize the target APIs for tox / clinical studies on pilot plant scale followed by large / commercial scale
Planning the lab experiments as per the Gantt chart to meet the timeline for the projects
Preparing the weekly update and sharing to the project leader
Effectively utilize the available equipment’s such as jacketed reactor, parallel synthesized, HPLC and RC1 to generate documents and optimization of PRD process to scalable process.
Identifying the process related impurities and developing a robust process in-order to control the impurity or rejecting the impurity by purification method
Ensuring 100% compliance in cGMP, GDP and data integrity
Generating documents such as use test, solubility, halting time stability, stress experiments etc. for TTD and BMR preparations
Interacting with AD team MoA transfer for IPC, intermediate / Finished product, and raw materials
Minimum number of experiments as per the organization requirements and generating data which should help to scale up of projects
Analyzing the regular in-process samples in analytical lab
Possess the knowledge and exposure to environment, health, and safety (EHS) practices
Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab / plant safety
Attend training on environment, health, and safety (EHS) measures imparted company
Educational Qualification : MSc in Organic Chemistry / Chemistry
3-6 years post qualification relevant experience in Process Research and Scale up, preferably CRO background.
Technical / functional Skills :
Knowledge in literature search
Knowledge on TLC, Column Chromatography and Crystallizations
Understand the progress of the reaction and laboratory safety practices, understand reaction mechanisms, and Named reactions
He should be able to handle the shift operations independently
Experience of handling hazardous chemicals like NBL, DIBAL-H and corrosive reagents.
Hands on experience of handling of API equipment’s like, Reactor, Centrifuge, Vacuum tray drier and Hydrogentaor.
Having knowledge about handling of regulatory audits and customer audits
Behavioral Skills :
Should have the capability to work in a team and ability to handle demonstrate a good team spirit.
While possessing a good ability to follow instruction should also demonstrate innovative in his / her approach, good communication skills.
Should be proactive while working on allotted responsibility.