Scientist - CMC (Analytical)
Ferring Pharmaceuticals
Full time- 10+ years
- Not Disclosed
- Hyderabad, India
- Post Date: Apr 01, 2024
- End Date: Jun 01, 2024
- 10+ years
- Not Disclosed
- Hyderabad, India
- Post Date:Apr 01, 2024
- End Date: Jun 01, 2024
Skills:
- pharma
- mpharm
- Management
Job Description:
Responsibilities
- Carry out Analytical method development and pre-validation involved in assigned projects, protocols & reports, in compliance with Ferring QMS to achieve the objectives as per project requirements.
- Carry Out Author and review Analytical documents, not limited to method development reports, justification reports etc., to be built on strong scientific rationale, study designs & compliance with ICH, compendial & regulatory guidelines.
- Carry out & Ensure Analytical deliverables for formulation development, optimization & scale-up, as applicable to achieve the objectives as per project requirements.
- Support Analytical method validation and method transfer involved in assigned projects to achieve the objectives as per project requirements.
- Carry out Preparation and updating of Specifications, STPs, analytical protocols and reports for assigned projects to achieve the objectives as per project requirements.
- Carry out & Ensure Managing stability study related activities for assigned projects to achieve the objectives as per project requirements.
- Ensure Outside analysis co-ordination for routine & characterization tests and report review for assigned projects to achieve the objectives as per project requirements.
- Carry out Literature search for analytical & regulatory aspects of assigned project to achieve the objectives as per project requirements.
- Carry out Review of ELN experiments, Data, Reports and documents generated within lab & those received from CRO/CMO in line with defined quality standards.
- Support Procurement activities related to project & laboratory i.e. vendor contact, URS, SOW etc. in line with defined quality standards.
- Support Coordinating with Facility/Vendor for instruments and equipment AM, PM and regular maintenance in Analytical lab in line with defined quality standard.
Qualification & Experience
- Ph.D (preferred), M. Pharma/M.Sc in Pharma Chemistry from reputed University.
- Experience: M. Pharma/M.Sc in Pharma Chemistry with around 11-14 years of experience or PhD in Pharmaceutical Chemistry/Analytical Chemistry with 6-8 years of experience in analytical development for formulations.
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