Recruitment at Cisen Pharmaceutical India
Views:136 Applications:1 Rec. Actions:Recruiter Actions:0
Cisen Pharmaceuticals - Analytical Development Scientist (12-15 yrs)
- 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.