Assistant Manager : Manufacturing Science and Technology (MST)

Zentiva Poland; Ankleshwar; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Zentiva Poland seeks an Assistant Manager in Manufacturing Science and Technology to lead organic process development for APIs/intermediates in Ankleshwar, India. You will execute lab-scale experiments, optimize cost-effective reactions, and support tech transfers while ensuring compliance with GMP, safety, and regulatory standards.

The role requires a PhD or MSc in Organic Chemistry with 3–12 years of relevant experience and strong knowledge of analytical methods (NMR, HPLC, GC, UV, FTIR) to

Qualifications

• M.Sc or Ph.D in Organic Chemistry is required.
• 3–12 years of experience in organic process development.
• Experience with DOEs and QbD methodologies.
• Ability to perform synthetic experiments and analyze results.
• Familiarity with ELN data recording and regulatory compliance.

Responsibilities

• Execute in-lab experiments to develop cost-effective API/intermediates processes.
• Isolate, purify, and characterize APIs/intermediates/impurities.
• Support tech transfers and pilot plant shifts.
• Investigate deviations, perform root-cause analysis, report to QA.
• Compile data for DMF submissions and regulatory compliance.
• Ensure cGMP, safety, and quality requirements.

Skills

Organic chemistry

Synthetic experiments

Analytical methods

Troubleshooting

DoEs

QbD

Education

M.Sc or Ph.D in Organic Chemistry

Tools

NMR

Mass spectrometry

HPLC

GC

UV

FTIR

DSC

Job description

JOB TITLEAssistant Manager : Manufacturing Science and Technology (MST)REQUIREMENTSEducation / ExperienceM.SC OR PH.D. IN ORGANIC CHEMISTRYExperience: 3-12 yearsTechnical skills &Competencies / LanguageKnowledge of modern organic ChemistryKnowledge of performing synthetic experiments.Application of varied analytical methods.TroubleshootingKnowledge of design of experiments (DOEs).Knowledge of Quality by Design (QbD).Zentiva valuesAccountability, Authenticity, Collaboration, Courage and TrustJOB PURPOSEGenericProviding 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 EthicsKEY ACCOUNTABILITIESProcess development:Execute experiments with analysis on own in laboratories for developing cost-effective processes of APIs/intermediatesIsolation, Purification and characterisation of APIs/intermediates/impuritiesFacilitate Technology transfers/ shift in charge in case of Pilot plant technology transfer/productionSupport 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 estimationTimely closure of experiments and data compilation in report format.cGMP: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 reviewTraining of self and subordinates on quality and HSE systems.Instrumentation: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 resultsMust follow the data integrity principlesOtherComplying to HSE RequirementsIdentifying 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.