Role
Senior Research Associate / Asst. Scientist
Reporting to
Associate Director - CMC (Analytical)
Location
Hyderabad
Experience
3 to 5 years of industrial experience in analytical development of formulations. Working experience with complex injectables, hydrogels, large molecules, peptides etc. preferred
Qualification
M. Pharma/M.Sc. in Pharma Chemistry or Equivalent from a reputed university.
Purpose of the Role
Work as Individual Contributor as part of CMC (Analytical) function and contribute effectively towards timely achievement of CMC RD objectives.
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 Ensure Analytical support 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.
- 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.
- 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, quotes, URS, Coupa etc. in line with defined quality standards.
- Coordinating with Facility/Vendor for instruments and equipment AM, PM, and regular maintenance in Analytical lab in line with defined quality standard
Required Competencies
- Sound scientific approach writing skills
- Analytical Mindset
- Good communication skills
- Engagement accountability towards the defined purpose
- Good team player
Location
Ferring India FHPDC RD