Role: Sr. Research Associate - CMC (Analytical)
Reports to: Associate Director - CMC (Analytical)
Location: Hyderabad, India
Qualification: Ph.D. (preferred), M. Pharma/M.Sc. in Pharma Chemistry from reputed University.
Experience: M. Pharma/M.Sc. in Pharma Chemistry with around 9 -14 years of experience or PhD in Pharmaceutical Chemistry/Analytical Chemistry with 5-8 years of experience in analytical development for formulations.
Purpose of the Role: Work both as individual contributor and in collaboration with team to facilitate & drive timely achievement 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 experience 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