RAJENDRA SONAWANE

Played a key role in capital expenditure (CAPEX) planning for the establishment of a new facility, including equipment justification and budget allocation. Actively involved in the development of User Requirement Specifications (URS) for critical equipment such as lyophilizers and preparative HPLC systems, ensuring alignment with project goals and regulatory requirements. Successfully designed and developed cost-effective peptide synthesis routes, optimizing resource utilization and minimizing production costs. Preparation of cost sheets and find raw materials source for cost saving. Managing timelines, budgets, and resources Direct the design, optimization, and scale-up of complex peptide syntheses (utilizing SPPS, LPPS, and hybrid fragment condensation). Implement Quality by Design (QbD) principles to establish Critical Process Parameters (CPPs) early in development.Ensure rigorous process safety standards are met when handling highly reactive intermediates at commercial scales.Mentor and manage a team of bench chemists and analytical scientists, bridging the gap between scientific R&D and commercial plant operations.

Synthesis of peptide, Cleavage of peptide from Resin, Purification of crude peptide , Drying of peptide. Assist in HAZOP studies and risk assessment of new products. At the time of implementation of new project at plant coordinate with engineering and R & D for equipment mapping, process parameters, execution of scale-up & validation batches. Route design & Lab maintaining. Procurement of raw materials for product development by using SAP. Maintaining lab activity with zero accident. Assign synthesis activities to various team members based on shift planning. Trigger IQ,OQ, PQ of newly installed or modified equipment. Performed computerized system validation (CSV) of highly sophisticated instruments, equipments and facility qualification activities. Good knowledge of the preparation of cost sheets and raw materials source.

Developed process for different peptide molecules synthesis from milligram to gram scale using different chemical methods like DIC/HOBT, HBTU/DIPEA. Developed critical peptides by Linear as well as Fragments strategy. Handling process improvement for yield optimization, cost reduction and operational convenience of the project. Isolation & characterization of impurities for developed peptides. Cleavage and partial cleavage of peptide from Resin, Purification of crude peptide ,Drying of peptide, Synthesis of peptide chain using both manually as well as automatic programmable peptide synthesizer (USA Synthesis CS-936, CS Bio Co.) Purification of different peptide based molecule using preparative HPLC with high purity greater than 99% and single max impurity less than 0.5%. Calibration and column packing of Novasep preparative HPLC and Knauer Preparative HPLC. Handled Analytical HPLC, Semi preparative, Preparative HPLC with 150 mm ID, 200 mm ID,450 mm ID columns. Design recipe or cycle for Lyophilization of peptides products using auto & manual mode of Lyophilizer or freeze dryer. Scale up projects from lab scale to plant scale. Procurement of raw materials for product development by using SAP. Maintaining lab activity with zero accident.

Solid phase manufacture of Synthetic Peptides. Synthesis of peptide chain using both manually as well as automatic programmable peptide synthesizer Purification of different peptide based molecule using preparative HPLC with high purity greater than 99% and single max impurity less than 0.5%. Handled Preparative HPLC with 150 mm ID, 200 mm ID,450 mm ID columns. Calibration and column packing of Novasep preparative HPLC. Purification of different peptide based molecule using preparative HPLC with high purity greater than 99% and single max impurity less than 0.5%.

Solid phase peptide synthesis and Solution phase manufacture of Synthetic Peptides. Synthesis of peptide chain using both manually as well as automatic programmable peptide synthesizer (USA Synthesis CS-936, CS Bio Co.) Purification of different peptide based molecule using preparative HPLC with high purity greater than 99% and single max impurity less than 0.5%. Tangential flow filtration systems for micro, dia and ultra-filtration 10 X scale cGMP facility installation and has been designed for US FDA regulatory compliance.

Purification of different peptide based molecule using preparative HPLC with high purity greater than 99% and single max impurity less than 0.5%. Handled Analytical HPLC, Semi preparative, Preparative HPLC with 150 mm ID, 200 mm ID,450 mm ID columns. 10 X scale cGMP facility is under installation and has been designed for US FDA regulatory compliance. Calibration and column packing of Novasep preparative HPLC and Knauer Preparative HPLC.

Pursuing doctorate degree from Sandip university.

First class