Job description :
- R&D Scientist - Formulation Scientist
- Pharmaceuticals/ Biotechnology/ Clinical Research
Required Candidate profile:
Education : - Doctorate / Masters in Pharmaceutics, Pharmaceutical Chemistry, Industrial Pharmacy, Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry or Medicinal Chemistry.
Experience : 5 - 10 Years
Domain : Pharmaceuticals
Location : Haryana
- In-depth understanding of physical pharmacy, physical chemistry, thermodynamics, chemical reaction kinetics is a must.
- In-depth understanding of various pre- formulation and formulation studies including excipient compatibility, forced degradation studies and unit steps in formulation manufacture is a must.
- Experience with pilot-scale and manufacturing-scale equipment is a plus.
- Experience with process analytical technologies (PAT) is a plus.
- Conduct API, excipient, packaging or device characterization; excipient compatibility and forced degradation studies.
- Develop robust lab-scale, pilot-scale and commercial-scale manufacturing process based on Quality by Design (QbD) principles using design of experiments (DOE). Recommend stage appropriate acceptance criteria. Utilize PAT where feasible. Utilize relevant statistical tools, as required.
- Review and analyze relevant stability data from lab-scale, pilot-scale and commercial-scale, R&D and GMP stability studies by utilizing industry standard modeling and analysis tools including regression analysis for shelf-life prediction. Develop and implement strategies to control related substances, where applicable.
- Draft high-quality industry standard technical documents (protocols, reports, technical memorandums, position papers etc.).
- Independently draft and/or review standard operating procedures (SOPs).
- Maintain effective and pro-active communication and coordination of activities with multi-functional stakeholders.