Principal Scientist

Job Description

Literature search and patent review of products

Responsible for formulation development of DPI, SMI & pMDIs formulations for US, EU, ROW, CSI and IRF markets.

Responsible for planning and execution of development- Pilot / Scale-up and Exhibit activities for pulmonary formulations.

Responsible for preparation of timelines, costings for ongoing projects.

Responsible for preparation and compilation of project related documents in compliance with quality and regulatory requirements.

Responsible for lab maintenance and upkeep of the laboratory and equipment’s

Responsible for analytical data and interpretation for way forward

Responsible for procurement and control of innovators samples and maintaining their records.

Responsible for Coordination with planning, engineering department and purchase department for product related activities

Responsible for Preparation of department SOPs, guidelines, product related protocols and tech transfer documents along with DQA, CQA and regulatory team.

To provide timely support for cross functional activities like regulatory queries, clinical development, technical support to manufacturing plants and intellectual property related inputs and feedback.

To provide support for launching and troubleshooting of approved products.

Work Experience

12 years + 

Education

Competencies