Research Associate - Analytical Development
Description
Job Description
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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 & R&D objectives.
Job Description
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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.
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Carry out & Ensure Analytical support for formulation development, optimization & scale-up, as applicable to achieve the objectives as per project requirements.
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Support Analytical method validation and method transfer involved in assigned projects to achieve the objectives as per project requirements.
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Preparation and updating of Specifications, STPs, analytical protocols and reports for assigned projects to achieve the objectives as per project requirements.
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Carry out & ensure managing stability study related activities for assigned projects to achieve the objectives as per project requirements.
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Ensure outside analysis co-ordination for routine & characterization tests and report review for assigned projects to achieve the objectives as per project requirements.
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Carry out Literature search for analytical & regulatory aspects of assigned project to achieve the objectives as per project requirements.
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Review of ELN experiments, Data, Reports, and documents generated within lab & those received from CRO/CMO in line with defined quality standards.
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Support Procurement activities related to project & laboratory i.e. vendor contact, quotes, URS, Coupa etc. in line with defined quality standards.
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Coordinating with Facility/Vendor for instruments and equipment AM, PM, and regular maintenance in Analytical lab in line with defined quality standard
Required Competencies
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Sound scientific approach & writing skills
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Analytical Mindset
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Good communication skills
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Engagement & accountability towards the defined purpose
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Good team player
Location
Ferring India FHPDC R&D