Ramesh Aachariar M.Tech., Email & Phone Number

United States

Framing Quality System for Cell and Gene Therapy Products in-line with the Global standards especially USFDA and European Medical Agency.

Bangalore

• Framing and implementing the quality management system for advanced therapy medicinal products (CAR-T) / gene therapy products as per the Indian and global standards to ensure the regulatory compliance of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP) activities. • Handling and release of raw material (apheresis material), ancillary materials, and final batch release for transfusion. • Prepare the apex documents which include quality policy, site master file, and quality manual also prepares the quality SOPs/documents to support R&D, manufacturing, quality control, and other functions.• Putting the internal quality standards for the process development, method development, method qualification/validation, method transfer, technology transfer, and technical/scientific report preparation for ATMP products as per Indian and global standards.• Management of equipment lifecycle includes the URS, risk-based impact assessment, DQ, IQ, OQ and PQ, requalification, and discontinuation/scrapping of equipment/instruments.• Active role in creating the digital platform for the quality management system which includes SOP management, change management, non-conformance, CAPA, incident, vendor management, self-inspection, product complaints-recall, and clinical sample management.• Management of document control includes the versions controlled, change control, issuance, retrieval, and archival.• Provide the necessary training on the GCT (gene and cell therapy) quality system to the scientific communities and manage the training tracker/documents.

Ahmedabad, Gujarat, India

• Establishing the quality system for gene therapy activities. • Responsibilities include implementation and maintaining the quality system and compliance for gene therapy product developmental (R&D) activities.• Established the necessary quality system for R&D activities which includes but not limited to program coding/nomenclature, SOP preparation, training procedure, good documentation practices, writing practices / raw data recording procedure for lab notebook, logbooks, equipment qualification, change management, batch numbering, data review, and compliance procedures. • Created and maintained the internal standard for analytical method development, qualification, activities, also for the process, product development activities, and scientific reports. • Review and approve all R&D scientific SOPs, equipment/instrument SOPs, and reports which are pertaining to process and analytical by ensuring the documents are as per the defined internal quality system. • Review and approval of equipment and instrument URS, Impact assessment, equipment qualification protocols/reports (DQ, IQ, OQ, PQ). Training on quality systems/QA SOPs to the scientific teams.• Document management includes the issuance, archival, retrieval, and management of archives.

Bangalore

• Documentation review, Audits compliance, Review of all biologicals Protocols/Reports belongs to Method Development, Method Qualification, Method Validation, Development Reports, Technical Reports.• Data and document review which are generated by the clone development team, upstream, downstream, formulation, characterization, analytical, bioanalytical, and bioassays labs for the analytical similarity of the biosimilars.• Review of data to ensure the data integrity in the technical reports, comparability study, characterization study, process scale up and scale down study, analytical study, assays, development study, non-clinical study, justification of specifications (JOS), outsourced sample study, data compilations, fit for the purpose for any compendial methods.• Review of audit trails for all instruments and equipment which are used for generation of biosimilars data which includes but not limited to cell analyzer, Akta chromatography system, HPLC/UPLC for IEX, SEC data generation, LCMS, isoelectric focussing, glycan data, FT-IR, spectrophotometer, biacore, spectramax data.• Review of bio-similarity and analytical similarity data for the FDA and EMA regulatory submissions. SPOC from QA for the top priority molecules for the bio-similarity data review.

Chennai

Handling of Bacterial cultures, Revival, sub-culture,scale-up, Milling and Harvesting of Mycobacterium bovis.Preparation/Reviewing of SOP,s and Handling of Deviations, Change control, OOS, OOT.

Tiruchirappalli, Tamil Nadu, India

Involved in the Advanced Drug Delivery System.

Chennai Area, India

Master Of Technology (M.Tech.), Biopharmaceutical Technology, 8.5 Cgpa

Activities and Societies: Attended national seminar/workshop/symposium presented by various biotech experts from various universities.

Bachelor Of Technology (B.Tech.), Biotechnology, 78 %

Activities and Societies: Attended national seminar/workshop/symposium conducted by biotech experts from various universities on various.