Zentiva

Produces branded generic pharmaceuticals in Europe

Assistant Manager: Manufacturing Science and Technology - Manufacturing Science and Technology

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours

Full-timeAnkleshwar, Gujarat, IndiaNo salary listedIn-person

About the Job

Requirements

A Master of Science or Ph.D. in Organic Chemistry.
Three to twelve years of experience.
Knowledge of modern organic chemistry and performing synthetic experiments.
Ability to apply varied analytical methods and troubleshoot.
Knowledge of design of experiments and Quality by Design.
Knowledge of NMR, mass spectrometry, HPLC, GC, UV, FTIR, and DSC for interpreting results.
Ability to follow data integrity principles.
Ability to comply with current GMP and regulatory guidelines, local and global quality, regulatory, and HSE norms.
Accountability, authenticity, collaboration, courage, and trust.

Responsibilities

Provide synthetic organic chemistry expertise for developing processes for APIs and intermediates and support customer DMF compilation while ensuring regulatory, group directive, quality, safety, and resource-utilization requirements and working transversally with cross-functional teams.
Execute laboratory experiments and analyses to develop cost-effective processes for APIs and intermediates.
Isolate, purify, and characterize APIs, intermediates, and impurities.
Facilitate technology transfers and take charge of pilot plant technology transfer or production shifts as needed.
Support production investigations of deviations by identifying root causes, performing experiments, and providing concise reports to QA.
Provide required data for DMF compilation.
Generate ideas for new APIs, intermediates, and cost-of-goods estimation.
Close experiments and compile data in report format on time.
Review pharmacopoeia and regulatory requirements regularly.
Train self and subordinates on quality and HSE systems.
Use the Electronic Lab Notebook to record laboratory experiments and ensure each experiment is signed and electronically closed within the stipulated time.
Comply with HSE requirements; identify and correct unsafe conditions or behaviours and promptly report other potentially hazardous situations.
Maintain the laboratory and perform asset preventive maintenance activities.
Carry out other assignments or projects as instructed by the Department Head to meet organizational objectives and priorities.

JOB TITLE

Assistant Manager : Manufacturing Science and Technology (MST)

REQUIREMENTS

Education / Experience

M.SC OR PH.D. IN ORGANIC CHEMISTRY

Experience: 3-12 years

Technical skills &

Competencies / Language

Knowledge of modern organic Chemistry
Knowledge of performing synthetic experiments.
Application of varied analytical methods.
Troubleshooting
Knowledge of design of experiments (DOEs).
Knowledge of Quality by Design (QbD).

Zentiva values

Accountability, Authenticity, Collaboration, Courage and Trust

JOB PURPOSE

Generic

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

KEY ACCOUNTABILITIES

Process development:

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.

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 review

Training 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 results

Must follow the data integrity principles

Other

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.

About the Company

Zentiva

Produces branded generic pharmaceuticals in Europe

Zentiva makes branded generic medicines for European markets. Its products are off-patent drugs reformulated and marketed under Zentiva’s brands, delivering the same active ingredients and dosage as original medicines at lower prices. It differentiates itself through a long history as an independent platform under private equity, with a growth strategy built on acquiring brands to expand its European footprint. The goal is to become a leading European branded generics platform and improve access to affordable medicines across its markets.

Company size: 1,001-5,000
Company stage: IPO
Headquarters: Prague, Czechia
Founded: 2003

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