Role: Senior Research Associate / Asst. Scientist
Reporting to: Associate Director – CMC (Analytical)
Location: Hyderabad
Experience: 7 to 10 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 & R&D objectives.
Job Description:
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
• Good communication skills
• Engagement & accountability towards the defined purpose
• Good team player
اطلب مساعدة الخبراء لكتابة سيرة ذاتية مميزة.