Job ResponsibilityJob Description:
1. Lead product improvement and line extension projects by providing product reformulation or process change proposal and oversee implementation of the improvement initiative until its successful conclusion.
2. Prepare Chemistry, Manufacturing and Controls (CMC) documentation for product improvement and line extension projects and address all regulatory queries.
3. Key technical liaison with Contract Manufacturers by coordinating preparation of CMC documents, providing support for in-house analytical method development and validation, monitoring stability data and provide technical inputs if necessary, institute post-approval changes until its successful conclusion.
4. Responsible for functional evaluation of alternative/new material source and coordinate benchtop trial batch manufacturing if deemed necessary
5. Reports to R & D Manager on matters pertaining to technical support needed for plant operation.
Requirements:
o Degree or Master in pharmaceutical science
o 3 - 5 years experience in formulation development
o Knowledge / skill in Formulation and process development, QbD
Job RequirementsJob Benifits
