11 Msat Jobs

Responsible to ensure Technology Transfer activities (From R&D to site, From Site to site). Manage the Scale-up, Process Optimization, submission batches, Process Validation, Process Improvements & Troubleshooting activities. Ensure timely execution of Feasibility, Assessment, Registration, New product launches and AVD projects by continuous co- ordination with unit Production, QC, ADL, RA and Project Management Team. Monitoring the progress of product status during stability study, responding the queries from various regulatory bodies. Review of Process Optimization reports. Review of gap analysis and define the action plan. To provide technical inputs for closure of OOS/OOT. Identification...

Role & responsibilities Coordinate and execute technology transfer activities for OSD and oral liquid projects from R&D to manufacturing. Prepare technology transfer protocols, risk assessment, and related documentation. Collaborate with cross-functional teams including R&D, QA, QC, and production for smooth transfer. Troubleshoot and resolve process-related issues during scale-up, exhibit, and commercial batches. Ensure compliance with regulatory and quality standards during tech transfer. Prepare and present reports related to technology transfer activities. Participate in investigations and root cause analysis pertaining to tech transfer failures or deviations. Preferred candidate profile...

Job Overview: The PDL Scientist - Injectable will be responsible for the development, optimization, and scale-up of sterile injectable formulations and manufacturing processes. The role demands expertise in injectable formulation science, process engineering, and compliance with regulatory and quality standards. Role & responsibilities Formulation Development: Design and optimize sterile injectable formulations, including solutions, emulsions, and suspensions. Perform compatibility and stability studies of active pharmaceutical ingredients (APIs) with excipients. Process Optimization: Develop robust, scalable manufacturing processes for injectable formulations. Define and optimize critical p...

Responsible for Technology Transfer activities (From R&D to site, From Site to site). Responsible for Execution of Placebo, Scale Up & Trail Batches. Review of validation protocol/report, responsible for manufacturing of validation batches. Preparation of scale up and trail batch summary to support the commercialization of products. Coordination with quality control department & quality assurance department for getting analytical data with respect to process optimization batches & validation batches

Greetings from Kashiv Biosciences!!! We are looking for Upstream Process Development Specialist( MSAT) for our Biosimilar manufacturing facility( R&D Center) based out of Ahmedabad. Following are the Roles and Responsibilities Roles & Responsibilities Responsible for Upstream Process Development for Mammalian Cell culture. Responsible for Scale Up from Pilot study to Bulk Manufacturing. Technology Transfer from R & D to Manufacturing . Qualification and validation of equipment. Exposure to Perfusion process and technique is must. CHO clone development, Clone screening, Shake flask studies, media optimization and bioreactor process development. Candidate Details The Candidate should be a Ph.D...

Summary Job Functions: Handling, supporting and executing all activities including training to subordinates for manufacturing process support and any late stage developmental work for process improvement related to Downstream process in MSAT. Key Responsibilities: - Execution of process scale up experiments, documentation and process improvements to support manufacturing. - Process transfer and execution of tech. transfer with help of BBM. - Planning and executing experiments of DSP for process improvement, demonstrating and recording the same in proper format / report. - Designing and execution of scale down experiments to support manufacturing for scale up. (Bag evaluation/Filter sizing/Al...

Qualification : B Tech/M Tech - Chemical Engineering Ability to independently conduct/execute the following: Participate in process optimization and generating what if data related to plant. Process safety studies like TSU/DSC, RC1e generation wherever applicable. Technical calculations during lab experiments for cooling load and vent size. HAZOP studies and execute the batches following the recommendations given in HAZOP. Executing trial batches and submission of trial report. Troubleshooting and monitoring of the plant operations during the execution of new products. Calculating the manufacturing cost of new products. Scale-up of new products from R & D scale to plant scale. Preparation of...

Role & responsibilities Job Title: MSAT - Technology Transfer Specialist (Injectables) Job Summary: The MSAT Technology Transfer Specialist for Injectables will be responsible for overseeing the transfer of injectable drug products from development to commercial manufacturing. This role requires close collaboration with cross-functional teams, including R&D, Quality, Manufacturing, and Engineering, to ensure a seamless transfer process, operational excellence, and compliance with cGMP regulations. Key Responsibilities: Technology Transfer Oversight: Lead and coordinate the transfer of injectable drug products from development to commercial production facilities. Ensure that all documentation...

Job Overview: The PDL Scientist - Injectable will be responsible for the development, optimization, and scale-up of sterile injectable formulations and manufacturing processes. The role demands expertise in injectable formulation science, process engineering, and compliance with regulatory and quality standards. Role & responsibilities Formulation Development: Design and optimize sterile injectable formulations, including solutions, emulsions, and suspensions. Perform compatibility and stability studies of active pharmaceutical ingredients (APIs) with excipients. Process Optimization: Develop robust, scalable manufacturing processes for injectable formulations. Define and optimize critical p...

Execute and manage technology transfer of OSD products from R&D to manufacturing. Coordinate and monitor scale-up and exhibit batches in line with regulatory requirements. Ensure USFDA and other regulatory compliance throughout product development and scale-up. Prepare and review tech transfer documents , protocols, and reports (BMRs, MFRs, PVPs, etc.). Support investigation and troubleshooting of manufacturing issues, and suggest process optimization. Collaborate with cross-functional teams: R&D, QA, RA, Manufacturing, and SCM. Participate in audits and provide technical support during regulatory inspections. Drive continuous improvement initiatives to enhance productivity, cost efficiency,...

Key Responsibilities: - An executive with extensive expertise in Biologics Manufacturing: Product Technical Life Cycle Management. - Lead MSAT cell culture upstream projects and technical investigator. - Planning and designing using DOE approach for process development and characterization of upstream operations. - Working as team with other cross functional teams and contributing the domain expertise for advancing the pipeline molecules as required. - Identify opportunities for improving the product quality and quantity as per current and future market demand. - Hold time study of all process intermediate, reagent, media & Feed. - Perform all functions associated with process transfer and s...