Research Associate - Analytical Development

ferring; Hyderabad; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Ferring India FHPDC R&D in Hyderabad is seeking a Senior Research Associate / Asst. Scientist to contribute as an individual contributor in the CMC (Analytical) function.

The role focuses on analytical development of formulations and ensuring compliance with QMS to meet project objectives. You will carry out method development, pre-validation, support formulation development and scale-up, validation, data review, and coordination with CRO/CMO, vendors, and maintenance of instruments, emphasizing

Qualifications

• Qualification: M. Pharma/M.Sc. in Pharma Chemistry or Equivalent from a reputed university.
• 3 to 5 years of industrial experience in analytical development of formulations.
• Experience with complex injectables, hydrogels, large molecules, peptides preferred.

Responsibilities

• Carry out analytical method development and pre-validation per project requirements.
• Provide analytical support for formulation development and scale-up.
• Assist method validation and transfer for assigned projects.
• Prepare and update specifications, STPs, protocols, and reports.
• Manage stability study activities for assigned projects.
• Coordinate outside analysis for routine tests and report reviews.
• Conduct literature search on analytical and regulatory aspects.
• Review ELN experiments, data, and CRO/CMO documents.
• Support procurement activities related to project and lab.
• Coordinate with facility/vendor for instrument AM/PM maintenance.

Skills

Analytical thinking

Scientific writing

Communication skills

Team player

Accountability

Education

M. Pharma / M.Sc. in Pharma Chemistry or equivalent

Job description

Job Description:

• 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:

  • 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 R&D