Job Description:

This role will be responsible for the formulation development and optimization of oral solid and liquid dosage forms for the US market, ensuring successful product development from concept through technology transfer in compliance with regulatory and quality requirements.
Position / Job Title - AGM
Department - Formulation Development
Reporting To - Vice President
Location - Thane
Years of Experience - 15 to 20 years
Dosage Form - Solid and Liquid Orals
Job Responsibilities / Deliverables -
To understand project scope, define the activities and timelines and to ensure periodic monitoring and timely completion of the same.
To lead on the execution/development of recent formulations by investigating characteristics of API and its viability, safety and compatibility with other ingredients, defining the material characteristics, performing required testing, and conducting scale up studies.
To identify the resource requirement for the projects such as materials, manpower,



machine change parts as well as to assimilate all the literature information collected by project teams and ensure appropriate usage throughout development.
Develop R&D; plans and experimental designs by applying QBD principles for all new product development projects and processes: Analyze data to provide a relevant interpretation, draw valid conclusions and make appropriate recommendations for further advancement in the product development.
To effectively plan & coordinate execution of lab scale up/ optimization and pilot BE batches by ensuring strict adherence to lab GMP system and practices.
Timely review of Lab experiment notebooks as well as preparation and review of technology transfer documents.
To liaison and coordinate with technology transfer team / production team of respective manufacturing site to ensure seamless technology transfer by executing plant scale-up and exhibit batches as well as to review batch manufacturing and process validation documents.
Program for the optimi

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