Shrinivas Katkam

Experience

• 

  North Carolina State University

  Aug 2021 - Dec 2022

  Fermentation of recombinant Microorganisms-Set lab with 2L fermentors, prepared culture, and buffers, set parameters, and made inoculations-Assisted in conducting lab with more than 35 students, solving doubts, and maintaining record of data -Assessed and provided constructive feedback for assignments, problem sets, lab reports, and exams Global Regulatory Affairs for Medical Products-Assisted 90 students in understanding Global regulatory affairs concepts related to Medical products-Guided in conducting mock audits of a GMP manufacturing facility and documenting FDA non-compliance.- Assessed and provided constructive feedback for deviation reports, CAPA reports, non-compliance reports.

  • Graduate Teaching Assistant

    Aug 2022 - Dec 2022

  • Graduate Teaching Assistant

    Aug 2021 - Aug 2022
• 

  Biogen

  Jun 2022 - Aug 2022

  Poduct and Technical Development Intern

  -Assisted process development of AAV production for upstream and downstream processes -Screened multiple parameters using Ambr 15 bioreactor systems and AKTA chromatography -Proficiently communicated with teams from upstream and downstream-Followed regulatory affairs, cGMP, SOPs, and safety regulations and documentation practices

• 

  KBI Biopharma

  Apr 2023 - now

  Manufacturing Sciences Engineer

  Responsible for:-Provided Hyper care technical support for training, Engineering, and GMP manufacturing runs, offering hands-on troubleshooting and on-call support for successful and optimised production.-Collaborating as an SME with Manufacturing, Quality Assurance, and cross-functional teams to resolve deviations, investigations, and implement CAPAs.-Led change controls and conducted impact assessments in coordination with upper management to ensure seamless operations.-Authoring technical documents to conduct facility fit, control strategy, Continuous process verification, PFDs, etc.-Utilizing ASCtra, OSI PI vision, and MODA for effective data management such as BOMs, elogs, etc.- Downstream risk assessment and control strategy (FMEA) in collaboration with Process development, clients and Quality control.- Routine and non-routine sample plan- New process SOPs, Functional specifications, Technical documents.- International client and internal site-to-site collaboration. Show less