Formulation And Development Research Associate

Alkem Laboratories; Navi Mumbai; On-site; INR 600,000 - 800,000; Full time

Job summary

Alkem Laboratories is seeking a dedicated professional to support literature study, pre-formulation and development activities in a GMP/Regulatory environment. You will assist in formulation development, stability studies, analytical data compilation, and technology transfer from R&D to manufacturing, contributing to BE study preparations and documentation.

Additional responsibilities include the manufacture of a pilot BE batch in a GMP facility, submission of samples for in-vivo BE studies, and

Qualifications

Responsibilities

• Literature Study/Review and support in licensing documents preparation
• Pre-formulation Studies.
• Prototype formulation development and stability studies.
• Analytical data compilation and discussions
• Formulation and Process optimization at lab scale
• Manufacturing of pilot BE batch in GMP facility and sample submission for in-vivo BE study
• Documentation support and execution of scale-up and exhibit batches
• Specifications and Protocols requests and data
• Execution support and technology transfer of product from R&D to manufacturing location
• eLNB writing for given trialsAuthorized to sign (as Done/Prepared by):
• MFR, PDR, PER, Protocols etc. if applicable
• Study reports, Development reports, Lab note books etc.

Job description

Literature Study/Review and support in licensing documents preparation

Pre-formulation Studies.

Prototype formulation development and stability studies.

Analytical data compilation and discussions

Formulation and Process optimization at lab scale

Manufacturing of pilot BE batch in GMP facility and sample submission for in-vivo BE study

Documentation support and execution of scale-up and exhibit batches

Specifications and Protocols requests and data

Execution support and technology transfer of product from R&D to manufacturing location

eLNB writing for given trialsAuthorized to sign (as Done/Prepared by):

MFR, PDR, PER, Protocols etc. if applicable

Study reports, Development reports, Lab note books etc.