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Experienced scientist dedicated to excelling in the design and development of pharmaceutical products, emphasizing the enhancement of patient well-being. Expertise in pre-formulation studies, formulation technology, and process development leverages advanced methodologies to improve bioavailability for poorly soluble compounds across diverse dosage forms, including modified release, targeted delivery, and sterile preparations. Proven leadership skills include guiding teams, managing complex projects, and achieving strategic objectives through effective planning, mentorship, and cross-functional collaboration. Recognized for a collaborative approach and unwavering commitment to excellence, offering a fresh perspective and strong dedication to quality and success while aspiring to contribute as a scientific leader and subject matter expert in comprehensive development and manufacturing strategies.

• Over 10 years of experience in Pharmaceutical/Biopharmaceutical drug Manufacturing industry as a Process Engineer, Validation/Principal scientist and Quality Assurance with sound knowledge of Biopharmaceutical process design, Technology transfer, scale up, Drug product manufacturing and operation related activities in Pharmaceutical and Biopharmaceutical drug products.
• Depth knowledge and understanding of FDA 21CFR Part 210/211, 820, 11, ICH Guidelines and validations, Quality Assurance, Change control, CAPA, Trackwise, risk assessment, Deviations, and investigation, Root cause analysis.
• Experience working in cGMP environment, Good Manufacturing Practices (GMP) with Various dosage form formulations, Good Documentation Practices (GDP), Good Laboratory Practices (GLP).
• Detailed understanding and experience working of Drug substances, Excipients, API, drug product formulation of pharmaceutical and Biopharmaceutical drug products manufacturing in GMP environment.
• Familiarity with Quality System Management (QMS chapters) in terms of Validation and compliance, Tech transfer, Facilities, and engineering.
• Have depth knowledge of using applications like Track wise, SAP, Kneat eVal.
• Depth understanding and working experience with oral solid dosage form, parenteral/injectable dosage form, suspension operation and manufacturing, process, and product improvements.
• Knowledge about Regulatory requirements and filling.
• Knowledge and working experiences about managing Equipment life cycle from procurement to decommissioning.
• Experience in leading/working on Multiple projects for Biologics drug products and process characterization study for process improvements.
• Understanding and firsthand experience working on Data Integrity remediation project for laboratory analytical instrument to meet part 21CFR 11.
• Has gained expertise in generating and reviewing Computer Systems Validations CSV Deliverables according to 21 CFR Part 11, Data integrity requirements.
• Experience in preparation and review of Validation Protocols IQ/OQ/PQ documentation, Validation Master plan, validation summary report, SOPs, Protocol Deviation, Risk Assessment, Decommission protocols, Periodic Review Report.
• Firsthand Experience in drafting, Executing, and reviewing all SDLC qualification documents (QAP, RSCS, AT, RTM, QASR, SDI) protocols, and SOPs to ensure it meet GxP and FDA regulations.

Dynamic leader and innovator with extensive experience at Sanofi-Aventis Deutschland GmbH, specializing in drug delivery/formulation development and project management. Excelled in leading cross-functional teams to pioneer oral solid dosage forms of biologics, enhancing laboratory operations through analytical technologies. Proven track record in mentoring staff, with expertise in HPLC and project software applications. Fluent in English and German.

Innovative, accomplished, results oriented pharmaceutical professional with 12+ years of progressive experience across a broad range of product development functions in the pharmaceutical industry. Proven ability, to develop the drug products with strong technical background in pre-formulation, formulation development, process development / optimization and technology transfer. Good team handling skill with result oriented time management to meet the timelines. Seeking for challenging carrier in an innovative research organization, that will utilize my skills and expertise in the field of formulations for mutual benefit of me and organizational development. Organized Team Leader builds positive rapport, inspire trust and guide teams toward achievement of organizational goals. Strong facilitator adept at working cross-departmentally with co-management and top-level leadership. Excellent trainer and mentor. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.

Buvaneswari Ramamoorthy

Summary

Overview

Work History

Office Aministrator and Marketing Manager

Quality Control Analyst

Production and Quality Control Analyst

Education

Post Graduate Diploma - Computer Application

Bachelor in Science - Pharmacy

Bachelor - Pharmacy

Post Graduate Diploma - Computer Application

Skills

CUST

Timeline

Office Aministrator and Marketing Manager

Quality Control Analyst

Production and Quality Control Analyst

Bachelor in Science - Pharmacy

Post Graduate Diploma - Computer Application

Bachelor - Pharmacy

Post Graduate Diploma - Computer Application

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