Literature search, preparation of protocols & technical reports

• Responsible for Analytical Method Development for finished products (experience in analytical method. Development for stability indicating assay, related substance, content uniformity and dissolution etc.
• Responsible for Stability Analysis (Stability study for regulated market such as USA & EU Etc. for different type of dosage form
• Responsible for development sample analysis as per the formulation requirement.
• Responsible for Technology transfer at plant location (Designing protocol for technology transfer to Q.C. and execution through collaborative study and troubleshooting if any).

Job Specification (What type of Person do you require)

Qualification: MSc / M Pharm / PhD

Years of Relevant Experience: 1 – 7 years

Job Description (What this Person is supposed to do)

• Literature search, preparation of protocols & technical reports
• Responsible for Planning of daily work by maintaining GLP, cGMP’s as per company procedures
• Responsible for interpretation of analytical data and communicating the same to concern groups & individuals.
• Development of analytical methods for testing & characterization of sterile drug products (Peptide injectable, Liposomes, Microspheres, Nanosuspension, Nano-emulsion etc.)
• Method development for assay, related substances, Dissolution, Residual solvents, reverse engineering etc. with different analytical instruments like HPLC, UPLC, GC, CAD detector, ELSD detector, USP Type-I,II,IV & non-conventional dissolution apparatus etc.
• Understanding of applicability of QbD principles in analytical development & validation is mandatory
• Characterization techniques like molecular weight, particle sizing, viscosity, surface tension, zeta potential, thermal methods (TGA, DSC etc.), surface properties, microscopic techniques will be highly desirable

Job Specification (What type of Person do you require)

Qualification: M Pharm / PhD

Years of Relevant Experience: 1 – 5 years

Job Description (What this Person is supposed to do)

Literature search, preparation of protocols & technical reports

• Experience in handling of complex Injectables like Peptides, Liposomes, microspheres, emulsions, and Suspensions etc.
• Analytical method development for assay, related substances, Residual solvents, Dissolution, reverse engineering etc.
• Characterization techniques like molecular weight, particle size (DLS), viscosity, surface tension, zeta potential, microscopic techniques will be highly desirable
• Analytical method validation exposure will be of additional value.
• Understanding of analytical method transfer requirements will be desirable.
• Responsible for interpretation of complex analytical data which includes statistical evaluation and communicating the same to concern groups & individuals.
• Multi-tasking capability along with ability to think-out-of-the-box will be highly desirable.
• Require good interpersonal skills, effective verbal & written communication skills.