Research Associate - CMC

Role: Research Associate - CMC (Analytical)

Reports to: Associate Director - CMC (Analytical)

Location: Hyderabad, India

Qualification : M. Pharma / M.Sc. in Pharma Chemistry from reputed University.

Experience : A round 3 to 5 years of experience in analytical development for formulations .

Purpose of the Role: Work both as i ndividual c ontributor and in collaborat ion with team to facil itate & drive timely achi e ve ment of CMC & R&D objectives , from CMC (Analytical) function .

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 Author and review Analytical documents, not limited to method development reports, justification reports etc., to be built on strong scientific rationale, study designs & compliance with ICH, compendial & regulatory guidelines.

• Carry out & Ensure Analytical deliverables 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.

• Carry out 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.

• Carry out 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, URS, SOW etc. in line with defined quality standards.

• Support Coordinating with Facility/Vendor for instruments and equipment AM, PM and regular maintenance in Analytical lab in line with defined quality standard.

Preferred Competencies in the role.

• Working e xperi e nce with diverse dosage form and differentiated products preferred .

• Timely achievement of the project deliverables

• GDP/GLP compliance ensured for data, lab operations & processes.

• Sound scientific & communication skills

• Strong Leadership Skills

• Critical thinking, troubleshooting and problem-solving skills.

• Engagement & accountability towards the defined purpose

• Good team player