Senior Manager R&D API Pharma

Role & responsibilities

1. ROS Finalization with respect to non-infringement.

2. RMC and over head costing evaluation.

3. DOE on basis of QbD

4. Technical Support during Project development

5. Analytical Data Evaluation

6.PDR Review

7. Technology Transfer

Detailed JD:

1. Responsible for below R&D activities and reporting to Sr. Manager or Corporate head R&D
2. Responsible in engage in new product & research and development, existing product optimization, quality

Checks /updates and conducting extensive research study.

1. Responsible for effective implementation of department standard operating procedure
2. Develop and manage project scope, strategies, budget, timelines and project status report.
3. Responsible for planning and coordinating the team members in the execution of experiments during development.
4. Responsible in developing products to regulatory requirements and resolution of technical issues in existing products.
5. Maintain accurate project information and ensuring product meets specification.
6. Responsible for monitoring to comply with GMP.GLP requirements and assist to team in following necessary

Good documentation practices.

1. Responsible to part of investigation carried related to process failures during execution in R&D and plant level.
2. Responsible for assessing appropriate safety measures to be followed during handling of dangerous reactions.
3. Responsible for the selection of route for process optimization and validations.
4. Work in collaboration with marketing. Analytical development, Development quality assurance departments and other related departments.
5. Collaborate with analytical development to create and review specifications for raw materials,

Intermediates, In process, recovery and finished products.

1. Work with operations to trouble shoot technical issues during pilot batches execution.
2. Review of PDR, Optimization reports validation protocols &other necessary documents related to process development.
3. Participating as a team member during the tech transfers, coordinate plant trials and new product startups.
4. Responsible for delivering explanation /solutions for regulatory queries related to the process with coordination of other departments & supporting to RA department in DMF submission.
5. Responsible for supporting in IPR evaluation for the process identified.
6. Responsible for conducting & coordinating on the job and technical trainings on need basis
7. Any other job assigned by superior