Lead Research Scientist - Liquid Dose

Job Description

Job Summary

To plan and execute the product developmental activities and to ensure proper documentation, follow  procedures as per the requirements of Apotex Research Pvt. Ltd.

Job Responsibilities

1. Prepare site specific plan for the CMO requirements during batch documentation and ensure the timely execution of projects
2. Conduct literature survey and compile the scientific findings
3. Plan and perform the Pre-formulation studies, and innovator product characterization
4. Planning and execution of product development activities of assigned dosage forms
5. Preparation of study protocols and reports, product development report, MFR, SOP, etc.
6. Provide necessary inputs and extend support to procure API, raw materials, and packing materials for development batches
7. Provide necessary inputs and support for execution of any studies planned in external lab
8. Manufacturing of lab scale batches and support to CFT for evaluation of in-process, finished and stability samples
9. Issuance, maintenance, writing, review of raw data, completeness check and archival of laboratory notebook
10. Conduct formula and process optimization studies per regulatory standards
11. Prepare stability protocols as per regulatory guidelines, execute the studies and compile the results
12. Routine calibration of laboratory instruments
13. Execution of tech-transfer and monitoring of scale-up/exhibit/process validation batches at plant
14. Coordination with vendor and internal service engineer for installation, calibration, maintenance and trouble shooting.
15. Responsible for tech-transfer of injectable and ophthalmic formulations from R&D to commercial scale
16. To ensure smooth technology transfer of products developed at Apotex to CMO
17. Gap analysis - To evaluate the product feasibility, technology feasibility at manufacturing site along with gap analysis with available technology for site readiness
18. Documentation – Onsite documentation, and timely execution of scaleup, exhibit and validation batches
19. Risk assessment – To carry out the risk assessment to identify the impact of critical process parameters and critical material attributes
20. To design and review the sampling plan for scaleup, process optimization and submission batches
21. To study and verify the parameters established during development are still with in the determined design space in scaleup and exhibit batches
22. Report to next level manager regarding day to day activities.
23. Follow departmental SOPs to carryout the product development activities
24. Take up any other work as allotted per Department requirements

Job Requirements

• Education
  • M Pharma or MS in Pharmaceutics./  Pharma/ B Tech in Pharmacy
• Knowledge, Skills and Abilities
  • Experience in handling of Liquid, Injectable, ophthalmic dosage forms is a must.
  • Effective command over verbal and written communication with good interpersonnel skills.
  • Proficient in MS office tools.
  • Knowledge on preparation of various documents like SOPs, formats, protocols, reports etc.
  • Having well versed knowledge on regulatory guidelines
  • Experience in handling of Liquid, Injectable, ophthalmic dosage forms is a must.
  • Able to priortise the task, best in effective planning of work activities to meet the timelines.
  • Must have knowledge on handling of machinery/equipment related to parenteral dosage form
• Experience
  • Minimum 5 to 9  years of experience in Injectable, Liquid and Ophthalmic formulation development.
  • About 2 to 3 years of manufacturing experience of submission, commercial batches at CMO