Ayyappan Rathakrishnan

FAQ About Ayyappan Rathakrishnan

• What is Ayyappan Rathakrishnan's address?

  Ayyappan Rathakrishnan is located at
  Frederick, Maryland, United States

• What is Ayyappan Rathakrishnan's job title?

  Ayyappan Rathakrishnan is a
  •Trained and experienced in cGMP, GLP, and sustainable compliance. •Expertise in regulatory guidelines and industry practices. Strong product quality review experience. •Extensive experience with FDA Regulations, EMEA Regulations, ISO guidelines, and ICH guidelines. •Extensive experience in USP General Chapters. •Exceptional experience in Quality Control and Quality Assurance. •12-plus years of laboratory and people management experience in a commercial. •Extensive experience in sterile injectables, Cell, and gene therapy products, and CAR T. •Extensive experience with LIMS database, Track wise, MODA, and Veeva. •Extensive experience in managing projects and developing project plans. •Extensive experience monitoring and reporting the actual status of all activities. •Exceptional experience resolving scientific conflicts or problems. •Extensive experience in managing the review of all types of quality data. •Extensive experience in Environmental and utilities monitoring and product testing programs. •Ensure Site wide cGMP compliance in accordance with 21 CFR Parts 210 and 211. •Develop and Maintain quality systems. Initiation and approval of quality investigations, assessments, and reviews or evaluations of quality events such as deviations, CAPA, and change records, and recommend corrective actions/CAPAs related to cGMP and GLP issues. •Prepare and review batch analysis, stability tables, trend charts, and internal reports for Regulatory Affairs department. •Extensive experience in monitoring, reviewing, and assessment of ongoing stability test results. Research and Technical Expertise •Experience in Large Scale Bacterial Vaccines manufacturing with Quality Aspects, Fermentation (Upstream & Downstream Processes). • Large-scale fermentor operation 500 L (Bio-engineering) 1000 L (Shangai- rittai), vessel sterilization, media sterilization, seed inoculation, sampling, harvest, decontamination. •Clarification of fermentation broth Tangential flow filtration method (TFF), conventional method, salting, dialysis, centrifugation, the concentration of toxoid using pellicon TFF system, vaccine purification, •DNA/RNA extraction, PCR technology: RT-PCR, Gel documentation and densitometry, western blotting, protein assay (lowry method) ELIZA, animal cell culture, histology, Immunohistochemistry. •Formulation and development of TT vaccine, •Aseptic technique, GMP, GLP, Sterility assurance, Microbiology, and Biosafety test( Endotoxin, Bioburden, Mycoplasma, and Virology assay) •Animal testing for tetanus vaccine (MLD, MTV, specific toxicity study, irreversibility). Astrazeneca

• What industry does Ayyappan Rathakrishnan currently work in?

  Ayyappan Rathakrishnan currently works in the
  Astrazeneca

• What is Ayyappan Rathakrishnan's area of expertise?

  Ayyappan Rathakrishnan specializes in
  •Trained and experienced in cGMP, GLP, and sustainable compliance. •Expertise in regulatory guidelines and industry practices. Strong product quality review experience. •Extensive experience with FDA Regulations, EMEA Regulations, ISO guidelines, and ICH guidelines. •Extensive experience in USP General Chapters. •Exceptional experience in Quality Control and Quality Assurance. •12-plus years of laboratory and people management experience in a commercial. •Extensive experience in sterile injectables, Cell, and gene therapy products, and CAR T. •Extensive experience with LIMS database, Track wise, MODA, and Veeva. •Extensive experience in managing projects and developing project plans. •Extensive experience monitoring and reporting the actual status of all activities. •Exceptional experience resolving scientific conflicts or problems. •Extensive experience in managing the review of all types of quality data. •Extensive experience in Environmental and utilities monitoring and product testing programs. •Ensure Site wide cGMP compliance in accordance with 21 CFR Parts 210 and 211. •Develop and Maintain quality systems. Initiation and approval of quality investigations, assessments, and reviews or evaluations of quality events such as deviations, CAPA, and change records, and recommend corrective actions/CAPAs related to cGMP and GLP issues. •Prepare and review batch analysis, stability tables, trend charts, and internal reports for Regulatory Affairs department. •Extensive experience in monitoring, reviewing, and assessment of ongoing stability test results. Research and Technical Expertise •Experience in Large Scale Bacterial Vaccines manufacturing with Quality Aspects, Fermentation (Upstream & Downstream Processes). • Large-scale fermentor operation 500 L (Bio-engineering) 1000 L (Shangai- rittai), vessel sterilization, media sterilization, seed inoculation, sampling, harvest, decontamination. •Clarification of fermentation broth Tangential flow filtration method (TFF), conventional method, salting, dialysis, centrifugation, the concentration of toxoid using pellicon TFF system, vaccine purification, •DNA/RNA extraction, PCR technology: RT-PCR, Gel documentation and densitometry, western blotting, protein assay (lowry method) ELIZA, animal cell culture, histology, Immunohistochemistry. •Formulation and development of TT vaccine, •Aseptic technique, GMP, GLP, Sterility assurance, Microbiology, and Biosafety test( Endotoxin, Bioburden, Mycoplasma, and Virology assay) •Animal testing for tetanus vaccine (MLD, MTV, specific toxicity study, irreversibility).

• Which languages does Ayyappan Rathakrishnan speak? 

  Ayyappan Rathakrishnan speaks the following languages:
  No languages available.

• Which industries has Ayyappan Rathakrishnan previously worked in?   

  Ayyappan Rathakrishnan has prior experience in the following industries:
  Astrazeneca , Sanaria , Sanaria , Sanaria , Idt Biologika , Lonza , Pii , Chantilly Biopharma , Moving Academy Of Medicine And Biomedicine Pune , Clinical Microbiology Techniques Sathyabama University General Hospital , Sathyabama University Dental College And Hospital , Indian Council Of Medical Research New Delhi , Pasteur Institute Of India Coonoor Government Of India Ministry Of Health , Government Of India Newdelhi , Oceanic Shrimping Limited Marakkanam And Pondicherry

• What is Ayyappan Rathakrishnan’s work experience?  

  Ayyappan Rathakrishnan has the following professional experience:
  Astrazeneca , Sanaria , Sanaria , Sanaria , Idt Biologika , Lonza , Pii , Chantilly Biopharma , Moving Academy Of Medicine And Biomedicine Pune , Clinical Microbiology Techniques Sathyabama University General Hospital , Sathyabama University Dental College And Hospital , Indian Council Of Medical Research New Delhi , Pasteur Institute Of India Coonoor Government Of India Ministry Of Health , Government Of India Newdelhi , Oceanic Shrimping Limited Marakkanam And Pondicherry .

• How can I find Ayyappan Rathakrishnan on LinkedIn?  

  You can view Ayyappan Rathakrishnan’s
  LinkedIn profile at LinkedIn URL.

• What are Ayyappan Rathakrishnan’s work email addresses?  

  Ayyappan Rathakrishnan’s work email addresses are
  [email protected] .

• What company does Ayyappan Rathakrishnan work for?  

  Ayyappan Rathakrishnan works at
  Astrazeneca