Senior Research Associate/ Asst. Scientist - CMC (Analytical)

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