About Us

passionate about driving success for businesses

Aurora Biotech Solutions, LLC

Aurora Biotech Solutions, LLC provides executive-led consulting services supporting cGMP manufacturing and quality operations across the pharmaceutical, biotechnology, and diagnostics industries. We partner with organizations to solve complex quality, compliance, and regulatory challenges within highly controlled manufacturing environments.

Executive Leadership & Organizational Development Mfg & QOPs
Audit readiness for FDA / CBER / CDRH / ISO / TGA Inspections
Advice on the remediation of GMP gaps
Equipment Qualification & Calibration Management
Commissioning Environmental Monitoring and Utility Control programs for GMP facility
cGMP manufacturing and technical operations supporting biologics and diagnostic products.
Investigations of deviation and non-conformances and process/product improvement
Provide technical and regulatory leadership for BLA preparation and review for technical accuracy.
Direct process, test method, cleaning validation, and stability programs

Results-oriented Leader with outstanding records, effecting change and building sustainable Departmental and Organizational capabilities in top-tier companies. Repeatedly called on to lead mission critical projects and other assignments into bringing Operational and Quality Excellence and Regulatory Compliance.

Professional Strengths:

Over 30 Years of Experience in Regulated industries Biotech/Pharma/Medical Device Industries with Quality & Operations responsibilities.
Demonstrated strategic thinker, innovative problem solver and champion for continuous improvement of Process Technology and Quality. Recipient of Roche Innovation Award in 2011.
Oversaw Quality Operations (Quality Control, Quality Assurance, Quality Compliance) from raw materials to final product QC testing and disposition. Manage service provider’s activities to insure Compliance to Company policies and Regulatory Standards.
Investigation for Root Cause Analysis and Resolution of non-conformances, deviations, excursions, BPDRs (Biological Products Deviation Reports), coordination of FDA Responses to inquiries on product approvals or audit findings, as needed.
Quarterly Assessment of Quality and Compliance status of the Organization through site Management Review of Plant Operations as required by regulations.
Established and Managed Roche Environmental Monitoring Plan for a new 300,000 Sq ft state of the art GMP facility and obtained FDA approval.
Remediation of GMP Compliance gaps and issues pertaining to training, analytical testing and overall investigations for root cause analysis, CAPA and POE.
Coordinated BLA and other documents and interface with Regulatory for FDA submission; Posses Expert Technical Writing and editing Skills by combining Science and Regulations.
Participated in numerous audits over the last 25 years by Regulatory Agencies such as, FDA CBER, CDRH Australian TGA, Canadian Blood Services and ISO Registrar audits; customer audits. Performed Supplier audits as part of the Supplier Qualification team for raw materials, testing and manufacturing services
Strong scientific expertise in product, processes, analytical development, Formulation, CGMP manufacturing, Regulatory, Quality and Technical Operation
Reputation for effective communication, developing high performing teams and building organizational relationships.

About Us

passionate about driving success for businesses

About Us

Aurora Biotech Solutions, LLC

Professional Strengths:

Karuppan Boominathan, PhD

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