14/01 Shankhajit
Recruitment at Cisen Pharmaceutical India

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Cisen Pharmaceuticals - Analytical Development Scientist (12-15 yrs)

Goa Job Code: 20579

- Ability to take full ownership for analytical activities required as part of their assigned projects, identifying technical problems/issues, developing solutions, and fully implementing these solutions with agreement from their Group Leader and Head of the Department where appropriate.

- Team oriented working style and Strong ability to identify issues and to resolve them

- Define the analytical strategy for new and ongoing projects, the strategy to develop, verify/validate or transfer analytical methods, stability study design etc.

- A thorough understanding of the pharmaceutical drug development process.

- Experience to interpret data of solid-state analysis like, TGA, DSC, XRD, GTI & Mass, NMR shall be added advantage.

- Significant experience of Lab Compliance, Response to regulatory deficiencies, internal audits, Chemia ELN etc

- Manage internal team resources/schedules ensuring adequate planning and resource allocation for assigned development projects. Report issues and propose solutions to Group Leader/Head of the Department on an ongoing basis.

- Knowledge on multimedia dissolution, Biorelevant and Discriminatory dissolution method developments.

- Prepare, review, and approve any protocols, reports, departmental SOP and other associated project / GMP documentation that are required to fulfill the projects or department's needs.

- Take full responsibility for OOS/OOT investigations and ensure all investigations are conducted in a thorough and timely manner in accordance with procedures. Support Senior Analysts in setting investigation strategies and approve the designs for investigations.

- Provide technical and operational training and coaching to Junior scientist.

- Significant experience of Method development, validation and verification for Dissolution, Assay, CU, and Related Substances for formulations products (Solid and liquid dosage forms).

- Candidate should have experience in analytical method development, testing, validation, and method verification with focus on Reverse engineering for RLD's.

- Knowledge on preparation of raw data sheets, Standard Operating Procedures, in-house analytical STP.

- Co-ordinate with other departments (DQA, FR&D, RA, etc.) for procurement, analytical method transfers activities, specification finalization etc.

- Accountable to all analytical related queries by different regulatory agencies and management.

- Preparation of Standard operating procedures, Guidelines & specifications as per regulatory requirements

- Proficient in Chromeleon software, Waters empower software, chem-station software

- Ensuring data integrity for day-to-day activities.

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