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Zentiva in Ankleshwar, India seeks an Assistant Manager for Manufacturing Science and Technology (MST) with advanced degrees in organic chemistry. The role focuses on developing cost-effective API/intermediate processes, supporting regulatory filings, and ensuring GMP compliance.
The incumbent will lead experiments, transfer tech, and mentor others. Candidates should have 3–12 years of relevant experience and strong analytical/DOE skills to drive successful tech transfers and continuous
Assistant Manager : Manufacturing Science and Technology (MST)
M.SC OR PH.D. IN ORGANIC CHEMISTRY
Experience: 3-12 years
Providing synthetic organic chemistry expertize for the development of processes for APIs/intermediates and DMF compilation support to the customer, ensuring compliance to regulatory, group directives, quality requirements, safety standards and effective utilization of resources, transversal cooperation with cross functional teams to fulfill the organization's objective, living Group's Values and Code of Ethics
Execute experiments with analysis on own in laboratories for developing cost-effective processes of APIs/intermediates
Isolation, Purification and characterisation of APIs/intermediates/impurities
Facilitate Technology transfers/ shift in charge in case of Pilot plant technology transfer/production
Support the production team for investigation of deviations. Identify the root cause, perform the experiments and provide a concise report to QA.
Providing required data for the DMF compilation.
New ideas generation for new APIs/Intermediates/COGs estimation
Timely closure of experiments and data compilation in report format.
Compliance to current GMP/Regulatory guidelines.
Compliance to local and global norms of Quality/Regulatory and HSE.
Regulatory compliance (Global/Local)
Regular Pharmacopoeia and regulatory requirement review
Training of self and subordinates on quality and HSE systems.
Effective use of Electronic Lab Notebook (ELN) for recording lab experiments making sure each experiment is signed and closed electronically within stipulated time.
Knowledge of NMR, Mass, HPLC, GC, UV, FITR, DSC, etc for interpretation of results
Must follow the data integrity principles
Complying to HSE Requirements
Identifying and correcting unsafe conditions or behaviours and promptly reporting others potentially hazardous situations.
Lab maintenance and asset preventative maintenance activities.
Carrying out any other assignments or projects as per the instruction of the Dept. Head to meet with the organizational objectives and priorities.