GlenMark Pharma - Research Scientist

Position summary :

- The role is focused on Identification, Isolation and characterization of impurities and providing support related to characterization of API, raw materials, intermediates and impurities to respond regulatory queries within the agreed timelines for various USDMF, EDMF, CEP, other regulatory and customer queries.

Overall Job Responsibilities :

Isolation of impurities on Preparative HPLC :

- To identify the requirement of impurity and arrange the crude from process lab, Plant or by degrading various samples at stress conditions, After crude availability, development of suitable isolation method on preparative HPLC.

- Characterization of isolated impurities as well as impurities received from synthetic process lab by using various techniques such as UV, IR, NMR and Mass.

- Characterization of Raw material, Intermediate, Final API Reference Standards and working standards from Glenmark plants.

- Preparation of Characterization reports and COA's for API reference standards, intermediate standards, raw material standards and impurity standards.

- Maintain the storage of all the standards, COA's and provide all the standards to Ankleshwar before sending the DHR. Also provide all the standards required for various customers and other locations of Glenmark as an when required

- Complete Impurity profiling for API as per ICH Guidelines. Isolation, purification, characterization and qualification of the impurities as per requirement.

- Respond to various requirement regarding US DMF deficiency and provide support related to characterization of API, raw materials, intermediates and impurities to respond regulatory queries to Regulatory team for various USDMF, EDMF, CEP, other regulatory and customer queries

Key Interfaces / Interactions :

External Interfaces :

- Service engineers for various instruments.

- Vendors supplying custom synthesized impurities.

Internal Interfaces ( Other than Direct Reports) :

- Analytical method development scientists and process scientists, QC chemists from plants,

- Regulatory and Marketing teams

Knowledge, Skills And Abilities :

Education (degree / diploma) :

- Ph.D/Post Doc (Chemistry)

Experience : 6-9 years

Knowledge and Skills (Functional / Technical) :

- Ability to handle various problems arising for the routine analysis and development of isolation method.

- Proper understanding of various requirements, knowledge of recent trends in regulatory

- Understanding of regulatory requirements for impurity profiling, different techniques to purify and characterize impurity.

Leadership / Managerial Attributes :

- Strong communication, interpersonal skills

- Highly organized and disciplined self-starter who is able to prioritize multiple tasks and deliver to deadlines