Abdulkhadar N

Experience

• 

  Biocon

  Jul 2016 - Feb 2017

  Research Trainee

  Research and Development (Upstream Process Development)

• 

  Stelis Biopharma

  Mar 2017 - Jun 2022

  Research and development of Biosimilars/VaccineUpstream Process Development:• Process Optimization: Refining and improving the efficiency of biopharmaceutical processes for biosimilars and vaccines at the lab scale.• Process Characterization: Detailed analysis of the production processes for biosimilars and vaccines in the lab.Laboratory Scale Operations:• Shake Flask Optimization: Utilizing Design of Experiments (DOE) approaches to optimize shake flask cultures for mammalian and microbial platforms.• Lab Scale Fermenters: Managing fermenters from 2 liters to 20 liters for initial process development and testing.Scale-Up and Technology Transfer:• Scale-Up: Expanding production processes from lab scale to larger bioreactors.• Technology Transfer: Transitioning processes to pilot scale, ensuring effective scaling and smooth handover.• Scale Support: Providing technical assistance during scale-up to maintain consistency and resolve issues.• Bioreactor Scaling: Managing the scaling of upstream processes in bioreactors ranging from 50 liters to 2.0 kiloliters (KL).Quality Management System (QMS) Coordination:• Trackwise and EDMS Handling: Overseeing change management and deviation handling using Trackwise, and managing protocol preparation and report approval through EDMS.• Team Training: Providing training on Standard Operating Procedures (SOPs) to ensure compliance and efficiency.Audit Coordination:• Audit Management: Coordinating audits to maintain and ensure adherence to current Good Laboratory Practice (cGLP) standards. Show less

  • Senior Research Associate

    Apr 2020 - Jun 2022

  • Research Associate

    Mar 2017 - Mar 2020
• 

  ShasunMed Life-Sciences Private Limited

  Jun 2022 - Aug 2023

  Deputy Manager

  Research and Development of Biosimilars/Vaccine/Biotransformation.Upstream Process Development:• Process Optimization: Enhancing the efficiency of biopharmaceutical production at the laboratory scale.• Process Characterization: Analyzing and understanding production processes for biopharmaceutical products at the lab scale.Laboratory Scale Operations:• Shake Flask Cultures: Cultivating microorganisms in shake flasks for preliminary development.• Lab Scale Fermenters: Operating fermenters ranging from 2 liters to 20 liters for small-scale production.Scale-Up:• Process Scaling: Expanding the production process from lab-scale to larger reactors.• Technology Transfer: Transitioning processes from laboratory to pilot scale, ensuring effective transfer and scalability.• Scale Support: Providing technical assistance during the scaling process to maintain consistency and address challenges.Large-Scale Production:• Scaled-Up Operations: Managing the production process in reactors ranging from 50 liters to 1.0 (KL).Facility Setup and Management:• R&D Facility Setup: Establishing and equipping facilities for upstream, downstream, and analytical processes.• Equipment Procurement and Lab Management: Acquiring necessary equipment, managing laboratory operations, and overseeing vendor interactions.• Client Interaction and Project Management: Engaging with clients, managing projects, and ensuring successful delivery of research and development goals. Show less

• 

  Hetero Biopharma

  Aug 2023 - now

  Assistant Manager

  CMC regulatory Science/ Biologics/mAbs• Monoclonal antibodies commercial manufacturing of drug substance & drug product regulatory filing.• Preparing and reviewing documents to get approvals from higher authorities. • Daily, weekly & monthly reporting to the higher authorities regarding the regulatory tasks. • Reviewing QMS elements like Change controls, OOS, OOT, and CAPA in the cGMP facility support. • Review of PDR, TTD, MFR, BMR, validation protocols, validation reports, stability protocols, stability reports, gap assessments, Analytical characterization, process characterization, SDM, Biosimilar assessment, JOS, PRS, SRS, IRS, AMV, Cleaning Validations and all commercial manufacturing documents of both drug substance and drug product. • Reviewing of all kind of ADL and QC methods, methods transfer and qualifications activity. • Training the people and developing team with new joiners and team skills development. Show less