Sr. Research Associate - CMC (Analytical)
Ferring Pharmaceuticals
Date: 3 days ago
City: Hyderabad, Telangana
Contract type: Full time
Job Description:
Role: Sr. Research Associate - CMC (Analytical)
Reports to: Associate Director - CMC (Analytical)
Location: Hyderabad, India
Qualification: M. Pharma/M.Sc.or Ph.D. in Pharma Chemistry, from reputed University.
Experience: M. Pharma/M.Sc. in Pharma Chemistry with around 5 - 9 years of experience or PhD in Pharmaceutical Chemistry/Analytical Chemistry with 3-6 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:
Role: Sr. Research Associate - CMC (Analytical)
Reports to: Associate Director - CMC (Analytical)
Location: Hyderabad, India
Qualification: M. Pharma/M.Sc.or Ph.D. in Pharma Chemistry, from reputed University.
Experience: M. Pharma/M.Sc. in Pharma Chemistry with around 5 - 9 years of experience or PhD in Pharmaceutical Chemistry/Analytical Chemistry with 3-6 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.
- 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.
- Preparation and updating of Specifications, STPs, analytical protocols and reports for assigned projects to achieve the objectives as per project requirements.
- Managing stability study related activities for assigned projects to achieve the objectives as per project requirements.
- Ensure external 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, 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.
- 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
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