Job Description
The candidate shall have the role of Analyst in Preformulation Sciences lab to support formulation development of NCEs, Specialty Projects, New modalities. Hands-on experience on HPLC/UPLC and high-end techniques like LCMS/MS, XRD, DSC TGA, FTIR , Raman Spectroscopy is a must. Ability to Interpret data from these techniques is a must. Additionally, he/she shall be responsible for co-ordination with formulation development team members and prepare Development reports.
Job title - Executive
Department - Preformulation Sciences
Reporting to - Manager
Location - Thane
Experience - 4 to 6 years
Dosage Form - Solid/Liquid Oral, Injectables, Nasal sprays, New modalities
Job Responsibilities / Deliverables -
Conduct Preformulation studies in function of pH solubility, pH stability profiling
Support formulation development and early phase projects including Advanced drug delivery systems
Design and execute Excipient compatibility studies in support of formulation development/screening
Perform preliminary Stress stability studies on API and provide inputs to Formulation team during formulation development/screening studies
Trace and track Impurity profile during formulation development/screening and support final formulation selection.
Evaluate Salts and Polymorph from a Physico-chemical characterization perspective and provide ranking on stability aspect in support of API development and flag issues/risks related to same
Excipient Screening for Advanced Systems: Lipids, Surfactants, Co-solvents
Maintain accurate documentation and prepare technical reports
Should have hands-on experience in performing HPLC/UPLC, LCMS/MS, DSC, TGA, XRD, Raman and FTIR. Ability to Interpret data from these techniques is a must.
To perform the calibration of instruments like HPLC/UPLC/GC etc
Follow the System / Operational SOP's.
Ensure data integrity and accuracy of data generated.
Should have knowledge of ICH and regulatory guidelines.
Collaborate with different departments as per the requirements.
Qualifications & Pre-Requisites -
M. Pharm Pharmaceutical Sciences /M. Sc. Analytical Chemistry
Knowledge of handling HPLC/UPLC etc
Exposure to Injectables, Nasal sprays, Solid, Liquid Oral dosage forms
Exposure to New modalities will be added advantage.
Additional notes
The candidate is expected to work in any of the shifts based on the requirements.
The candidate is expected to visit external sites as per the project requirements
