Sanjaykumar Shinde.

Experience

• 

  Reliance Life Sciences Pvt. Ltd.

  Jul 2007 - Aug 2011

  Mammalian Cell Culture(CHO cells)Successful contribution in Scale up, optimization of upstream protocols (Fermentation, harvesting, Clarification) and commercial manufacturing batches of therapeutic proteins and Monoclonal antibodies,Contributed efficiently to develop systems to counter contamination in large scale bioreactors.Microbial cell culture (E. coli):Actively involved in scale up, optimization of upstream protocols (Fermentation 100 liter scale), primary recovery (harvesting, solubilization and refolding of protein), purification (Concentration of proteins using TFF) & commercial manufacturing of therapeutic proteins.successful contribution in technology transfer of upstream processes and clinical/commercial manufacturing of all products. Weniger anzeigen Successful technology transfer and scale up of cell culture process.Successful technology transfer and scale up of fermentation,primary recovery(harvest),cell Lysis,IB solubilization and refolding protocols for therapeutic proteins. Successfully completed SAT, IQ, OQ, CTP of Fermenter(100 L), Bioreactor (10- 2500L), Continues Centrifuge and Homogenizer. Successfully performed Performance Qualification (PQ), Cleaning (CIP) Validation, and Sterlization (SIP) validation of Bioreactors, Continous Centrifuge and Homogenizer Weniger anzeigen

  • Senior Executive Manufacturing

    Apr 2011 - Aug 2011

  • Executive Manufacturing

    Jul 2007 - Jan 2011
• 

  Dr. Reddy's Laboratories

  Jul 2011 - Jan 2012

  Assistant Manager (Manufacturing)

  Commercial GMP manufacturing(Upstream processing: seed development,fermentation and harvest) of Rituximab at 200 Liter scale.Involved in technology transfer of cell culture process for Monoclonal antibodies(MAbs).Equipment commissioning and qualification.

• 

  Lonza

  Jan 2013 - Jan 2024

  • Downstream process equipment package owner of upcoming 6x20 KL mammalian manufacturing facility. • Work along with process engineering design team and MSAT through concept, basic and detailed design of all downstream process equipment’s for 6x20KL bioreactor scale. (Chromatography skid, columns, TFF skid, process vessels, VRF/DF skids, final fill systems). • Define, review and approval of design documents like URS, FS and TS. • Review and approval of C&Q documents like FMEA, DQ, P&IDs, IV,IQ and OQ protocols. • Supporting MSAT team through facility fit analysis of different customer products for downstream process.• Evaluate and identify fit to plant (customer process) requirements and implementation through CAPEX projects.• Active member of cross functional tech transfer project team (representing DSP operations) for customer process to the facility. • Defining the detailed operational workflows (Process Visio and Equipment Picasso layers) for all downstream operations and translating it to process automation in the form of Delta V and MES (Syncade) recipes. Review and approval of DeltaV/MES FS, sFAT etc. • Training, Coaching of operations team members and effective delegation of tasks. • Defined operational SOP landscape. SOP authoring, review, and approval. • Maintaining effective communication with cross functional teams like Equipment vendor (Project manager), Process Engineering, C&Q, automation, Quality Engineering, and quality assurance through different stages of the project. • Acting as a deputy to Head of DSP operations. • Actively involved in PQ studies planning and execution – Mixing studies, column packing, microbial hold studies, inline dilution studies etc.• C&Q execution • Campaign readiness of ENG campaign of customer product.• eBR review to support lot release.• Operation team building and development - Recruitment and interview candidates, traning and coaching. Weniger anzeigen Team lead for execution of purification process(DSP) for customer biopharmaceutical products(Monoclonal Antibodies,Proteins).Training team on Downstream operations,GMP, GDP and Quality Systems.Involved in Deviation management,Change control and CAPA.Author GMP documents like SOP,Batch record,Deviation Investigation report,Customer Memo,Change request summary reports,Equipment commissioning and qualification summary report. Execution of validation protocol for biopharmaceutical downstream process equipment's.Involved in process validation of customer biopharmacetical products and Cleaning validation of downstream process equipment's.Team Management and performance appraisal.Involved in Production planning,capacity utilization,cost reduction and delivery(lot release). Weniger anzeigen

  • Senior Bioprocess Engineer

    Jan 2021 - Jan 2024

  • Senior Section Lead

    Sept 2017 - Sept 2021

  • Section Lead

    Jul 2016 - Aug 2017

  • Senior Biotechnologist

    Apr 2015 - Jun 2016

  • Biotechnologist III

    Jan 2013 - Jan 2015
• 

  Biogen

  Jun 2024 - now

  Process Expert II, MTO