Clinical Material Manufacturing.• Leading the project from equipment selection to commissioning and qualification.• Post plant qualification, responsible for assisting in scale-up and technology transfer activities related to material manufacturing. Planning, executing, monitoring and control of clinical material manufacturing operations.• Preparation and review of cGMP documents like URS, SOP, batch manufacturing records, protocol and technical reports.• Investigating the deviation/nonconformities to identify the root-cause and Implementing CAPA’s to avoid recurrence.• Coordinating with other departments for clinical manufacturing activities.• Working on continuous improvement programs for operational efficiency and better compliance.• Evaluation and implementation of new technology like ATF.• Training and developments of team leads and team members for upstream and downstream.• Ensuring cGMP and EHS compliance in respective areas.

Biosimilar Manufacturing Upstream.• Lead a team to carry out commercial campaigns for cell culture products in Cell Culture Manufacturing Facility (Single Use Bioreactor 4X1000L scale).• Ensure fermentation batches are carried out as per SOP’s and to ensure proper documentation in order to maintain cGMP.• Validation of equipments related to fermentation process.• Ensure documentation such as completion of BPR, equipment log books, record sheets etc. is carried out properly.• Ensure proper maintenance of fermentation area and related facilities.• Initiating Cost Improvement Project.• Reducing COPE by systemic approach (CAPA).• Coordinating for tech transfer feasibility at commercial scale.

1. Upstream technical expert to carry out commissioning and qualification of upcoming single use Cell Culture Manufacturing Facility 4 (Flex Factory).2. Flex factory equipment assessment and qualification.3. Single use technology implementation in current product for commercial manufacturing.4. Alternating Tangential Flow (ATF) evaluation & implementation in current products for commercial manufacturing. 5. Ensure fermentation batches are carried out as per SOP’s and to ensure proper documentation in order to maintain cGMP.6. Validation of equipments related to fermentation process for upcoming facility.7. Initiating Cost Improvement Project.8. Reducing COPE by systemic approach (CAPA).9. Coordinating for tech transfer feasibility at commercial scale for upcoming products.10. Technology Transfer PD to commercial for products.

1. Lead a team to carry out commercial campaigns for cell culture products in Cell Culture Manufacturing Facility 2.2. Ensure fermentation batches are carried out as per SOP’s and to ensure proper documentation in order to maintain cGMP.3. Validation of equipments related to fermentation process.4. Ensure documentation such as completion of BPR, equipment log books, record sheets etc. is carried out properly.5. Ensure proper maintenance of fermentation area and related facilities.

1. To carry out commissioning and qualification of Bio-reactors and related fermentation equipment's in Cell culture Manufacturing Facility 2.2. Lead a team to ensure fermentation batches are carried out as per SOP’s and to ensure proper documentation in order to maintain cGMP.3. Validation of equipment's related to fermentation process.4. Ensure documentation such as completion of BPR, equipment log books, record sheets etc. is carried out properly.5. Ensure proper maintenance of fermentation area and related facilities.

1. To carry out commercial campaigns for cell culture products in Cell culture Manufacturing Facility 1.2. To ensure fermentation batches are carried out as per SOP’s and to ensure proper documentation in order to maintain cGMP.3. Validation of equipments related to fermentation process.4. To ensure documentation such as completion of BPR, equipment log books, record sheets etc. is carried out properly.5. To ensure proper maintenance of fermentation area and related facilities.

1. To carry out commercial campaigns for cell culture products.2. To ensure fermentation batches are carried out as per SOP’s and to ensure proper documentation in order to maintain cGMP.3. Validation of equipments related to fermentation process.4. To ensure documentation such as completion of BPR, equipment log books, record sheets etc. is carried out properly.5. To ensure proper maintenance of fermentation area and related facilities.

1. To carry out commercial campaigns for cell culture products in Cell Culture Manufacturing Facility 1.2. To ensure fermentation batches are carried out as per SOP’s and to ensure proper documentation in order to maintain cGMP.3. Validation of equipments related to fermentation process.4. To ensure documentation such as completion of BPR, equipment log books, record sheets etc. is carried out properly.5. To ensure proper maintenance of fermentation area and related facilities.