Senior Research Associate CMC – in Hyderabad at Ferring Pharmaceuticals
Ferring Pharmaceuticals is looking for a Sr. Research Associate – CMC (Analytical) to join its Analytical Development team in Hyderabad, India. This role is ideal for professionals with 5-9 years of experience (M. Pharma/M.Sc.) or 3-6 years (Ph.D.) in Pharmaceutical/Analytical Chemistry who are eager to contribute to analytical method development, validation, and regulatory compliance for formulation projects.
Job Description for Senior Research Associate CMC:
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 a 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
The purpose of this role is to work both as an individual contributor and in collaboration with a team to facilitate and drive the timely achievement of CMC and R&D objectives within the CMC (Analytical) function.
Responsibilities for Senior Research Associate CMC:
- 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 as Senior Research Associate.
- 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
- 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
Keywords: Ferring, Sr. Research Associate, CMC, Analytical, Pharma Chemistry, Hyderabad, India, Job Posting
