Research And Development-Chennai

Role & responsibilities

Analytical Research & Development (ARD) [API & FORMULATIONS]

• Experience in method validation, Method development and method transfer of new analytical methods by HPLC.
• Develop, optimize and validate new analytical methods for key starting materials, Intermediates and Active Pharmaceutical Ingredient products.
• Preparation of analytical method validation protocol, raw data and analytical method validation report as per ICH requirements.
• Manage and execute transfer of analytical methods from AR&D to internal QC.
• Analytical regular support for Process development team.
• Analytical regular support for Alternative vendor development projects.
• Perform hands on Residual solvents Unknown peak identification and quantification by GC troubleshooting.
• Maintenance of lab compliance such as calibration schedules etc.
• Performing a Qualitative and Quantitative tests which include analysis of raw materials, APIs and in process samples.
• Adequate Knowledge in Wet Lab Analysis.

Formulations Research & Development [FRD]

• Entrusted with the task of conducting research and support activity In Formulation Department and handling various projects like Oral Solid Dosage forms (Tablets, Capsules), Liquid Dosage forms etc.
• Proactively involved in formulation of Robust, Stable. Cost effective, Time effective various enzyme preparations s/a Solid Oral Dosage Forms like Tablets (Dispersible, Film coated, and IR) & Capsules. Preparation of Product Development Report, Master Formula Card, various SOPs etc.
• Actively involved in planning, review of analysis related activities, Installation and calibration of various analytical instruments.
• Scale-up and technology transfer of Softgel capsules, Spray drying and Beadlets technology.
• Product improvement and cost reduction of existing products.
• Coordination with marketing and analytical team or successful completion of projects
• Trouble shooting and quality improvement of existing products
• Preparation and review of Master manufacturing document (MMD), NPD documents, batch manufacturing record (BMR), product development report (PDR) , HACCP plan and Technology Transfer documents.

Process Research & Development (PRD) [API]

• Monitoring and planning of experiments with team.
• Recording the daily lab experiments as per cGMP and preparing weekly planning report.
• Preparation, identification, characterization and control of process related impurities and GTIs.
• Ability to complete the project with in stipulated time lines.
• Developing chemical processes for APIs and intermediates.
• Optimizing and validating the process at the lab,pilot and plant scale.
• Adequate response to the queries raised by competent regulatory bodies.
• Preparation of process development report(PDR) and technical packages.
• Co-ordinating with cross functional teams, collecting the data and supporting in the preparation of product development report.
• Identify & solve the plant related queries such as OOS OOT, CAPA.
• Obey & follow the safety norms.

If interested, please share your resumes to jayakishore.gollapalli@srikrishnapharma.com