Sudeep Sen

Experience

• 

  Dr. Reddy's Laboratories

  Apr 2008 - May 2011

  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.

  • Junior Manager

    May 2009 - May 2011

  • Technical Trainee

    Apr 2008 - May 2009
• 

  Dr. Reddy's Laboratories

  Jul 2011 - May 2014

  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. Show less

  • Assistant Manager

    Jul 2013 - May 2014

  • Assistant Manager

    Jul 2011 - Jul 2013
• 

  Dr. Reddy's Laboratories

  Jul 2014 - Jan 2022

  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. Show less 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. Show less 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. Show less 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. Show less

  • Plant Manager (MSAT - Clinical Material Manufacturing)

    Jan 2020 - Jan 2022

  • Manager Team Lead Upstream

    Oct 2018 - Dec 2019

  • Manager - (Product Operations - Manufacturing Science & Systems)

    Oct 2016 - Sept 2018

  • Manager

    Jul 2014 - Sept 2016
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  Thermo Fisher Scientific

  Dec 2021 - now

  Field Application Scientist