Principal Scientist-Formulation Development(OSD)

Aizant; Hyderabad; On-site; INR 2,400,000 - 4,200,000; Full time

Job summary

Aizant is seeking a Principal Scientist for its Hyderabad location to lead formulation development activities for Oral Solid Dosage (OSD) products. You will oversee development, optimization, scale-up, technology transfer, and documentation in line with regulatory standards.

The role requires 12–15 years of pharmaceutical R&D experience, strong leadership, and expertise in GMP/GDP environments. Collaboration across multiple functions and cross-site coordination will be essential.

Qualifications

• 12–15 years of pharmaceutical R&D experience.

Responsibilities

• Lead formulation development for tablets, capsules, and other OSD dosage forms from development to commercialization.
• Plan and execute formulation development trials and optimization studies.
• Develop robust formulations considering QTPP, CQAs, CPPs, material attributes, and product performance.
• Evaluate excipients, grades, and manufacturing processes.
• Conduct DoE/QbD-based formulation optimization.
• Coordinate with Analytical Development, IPQA, Quality Control, Regulatory Affairs, Engineering, and Manufacturing.
• Lead scale-up from lab/pilot to commercial scale.
• Support technology transfer to manufacturing sites.
• Address process issues and drive troubleshooting and optimization.
• Ensure GMP/GLP/SOP compliance and regulatory alignment.
• Mentor junior scientists and plan departmental activities.

Job description

Job Title: Principal Scientist

Department: Formulation Development(OSD)
Experience: 12-15 Years
Location: Hyderabad

Job Summary

We are looking for an experienced and result-oriented Principal Scientist to lead formulation development activities for Oral Solid Dosage (OSD) products. The role will be responsible for formulation development, optimization, scale-up, technology transfer, troubleshooting, and documentation in compliance with regulatory and quality requirements.

Key Responsibilities

• Lead formulation development activities for tablets, capsules, and other OSD dosage forms from development to commercialization.
• Plan and execute formulation development trials, optimization studies, and process development activities.
• Develop robust formulations considering QTPP, CQAs, CPPs, material attributes, and product performance requirements.
• Evaluate and select suitable excipients, grades, and manufacturing processes.
• Conduct formulation optimization using DoE/QbD principles wherever applicable.
• Coordinate with Analytical Development, IPQA, Quality Control, Regulatory Affairs, Engineering, and Manufacturing teams.
• Lead scale-up activities from laboratory/pilot scale to commercial scale.
• Support and execute technology transfer activities to manufacturing sites.
• Participate in process troubleshooting, investigation, and optimization of formulation/process-related issues.
• Ensure formulation development activities are conducted in compliance with GMP, GLP, SOPs, and applicable regulatory guidelines.
• Mentor and guide junior scientists/executives within the formulation development team.
• Plan departmental activities, timelines, resources, and deliverables to ensure timely completion of projects.
• Identify opportunities for process improvement, cost optimization, and product development.
• Maintain appropriate development documentation, laboratory records, and technical reports.
• Understanding of dissolution, stability studies, bioequivalence requirements, and product characterization.
• Knowledge of regulatory expectations and ICH guidelines related to pharmaceutical development.
• Strong analytical, problem-solving, leadership, and project management skills.
• Good communication and cross-functional coordination abilities.
• Experience in a pharmaceutical R&D / CDMO / product development environment will be preferred.