Scientist - Formulation Development(Oral Solids)

Aizant Drug Research Solutions Pvt. Ltd.; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Aizant Drug Research Solutions Pvt. Ltd. in Hyderabad is seeking Formulation R&D Scientists with 6-8 years of experience to lead formulation development efforts and ensure quality and regulatory compliance.

The role involves planning projects, coordinating with QA, and driving documentation from development to commercialization. The candidate will participate in literature searches, develop development strategies, and manage instrument qualification, stability studies, and reports within a GMP

Qualifications

• Strong foundation in formulation development is required.
• Experience with pre-formulation and scale-up activities is preferred.
• Ability to interpret analytical data and maintain compliant documentation.

Responsibilities

• Plan and execute pre-formulation and formulation activities to ensure timely project tasks.
• Participate in literature searches and develop formulation development strategies.
• Coordinate with QA for forms and logbooks and ensure GMP/GDP practices.
• Follow good laboratory practices and maintain logbooks for equipment/instruments.
• Coordinate internal department audits and sponsor or client audits.
• Coordinate with purchase for material procurement and vendor management.
• Assist in qualification of equipment and instrument pertaining to the department.
• Compile, interpret and review analytical results and stability data.
• Submit documents and coordinate with liaison personnel to procure licenses for development work.
• Initiate projects and assign product identification codes.
• Prepare Master Formulation Card, scale-up documents, stability and dissolution reports.
• Drive documentation from formulation development to exhibit batches and commercialization in the document management system.
• Prepare specifications for raw materials, in-process, and finished product.
• Prepare product development reports and summary reports for batches.
• Initiate change controls and revision/withdrawal controls as required.
• Coordinate departmental trainings and calibration of instruments.
• Prepare SOPs/Guidelines/Operating instructions for the department.
• Ensure ongoing compliance and traceability across development activities.
• Support exhibit/storage and process evaluation batches with proper documentation.
• Assist in coordination with QA and regulatory to maintain project timelines.
• Maintain collaboration with cross-functional teams to meet milestones.
• Assist in final handing over to manufacturing and QA teams.

Skills

Formulation development

Pre-formulation

Analytical data interpretation

Documentation practices

Regulatory compliance

Job description

Dear All,

We are seeking a highly motivated and talented Formulation R&D Scientists to join our innovative team. The ideal candidate will have a strong foundation in formulation development and you will play a crucial role in developing new and improved formulations, ensuring product quality, and meeting regulatory requirements.

Location: Hyderabad(Dulapally)

Required Experience: 6-8 Years

Job Responsibilities:

• 1. Plan and execute Pre-formulation and formulation activities and ensure the timely execution of project related tasks in coordination with team members.
• 2. Actively participate in the literature search and preparation of formulation development strategy.
• 3. Coordinate with QA department for getting forms and logbooks
• 4. Follow good laboratory practices, good documentation practices (online LNB writing) and maintain the logbooks and forms for equipment/instruments
• 5. Coordination and participation of internal department audits / sponsor or client audits
• 6. Coordination with purchase/sourcing department for procurement of materials
• 7. Participation in qualification of equipments/instrument pertaining to the department
• 8. Compilation, interpretation and review of analytical results and stability data
• 9. Submission of documents and coordination with liaison personnel for procuring required licenses for carrying out the development work
• 10. To initiate the project and allot the product identification codes
• 11. Preparation of Master formula card (MFC), scale up BMR, process evaluation plan, exhibit batch protocols, stability protocol, Dissolution profiling report, Assessment report, Tablet sub division study summary report and all documents related to Formulation development.
• 12. To drive all concerned documents from formulation development to exhibit batches and then to commercialization through document management system.
• 13. Coordinate to prepare the specifications for raw materials, in-process and finished product.
• 14. Preparation of product development reports (PDR)
• 15. Preparation of summary reports for exhibit and process evaluation batches.
• 16. Initiation of Change controls.
• 17. Initiation of document/ mandatory revision/withdrawal control form.18. Initiation of departmental incidents.
• 19. Conducting departmental trainings.
• 20. Calibration of instrument/equipment pertaining to the department.
• 21. Preparation and processing of department SOPs/Guidelines/Operating instructions.
• 22. Preparation of summary reports for exhibit and process evaluation batches