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Validation Expert

Kennesaw, Georgia, 30144, United States
January 12, 2011

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ANA MELÉNDEZ 770.***.****

**** ******** ***** **, ********, GA 30144


Dynamic Validation Scientist with extensive pharmaceutical experience researching and developing ways to manufacture products and monitor existing processes and products for quality and efficiency with standardized protocols. Collaborates with research scientists, process engineers and quality control technicians in achieving corporate objectives. Skilled in writing validation and qualification reports, packaging and cleaning protocols, standard operating procedures for processes and equipment, and investigation and troubleshooting reports. An analytical and creative professional who employs project methodologies that improve timeline adherence while ensuring regulatory compliance.

Computer skills: MS Office Suite, VISIO



Manager, Global External Clinical Trial Supply Manufacturing, 2009 – Present

Oversee all external manufacturing of clinical supplies in the US and Europe.

• Identify global external vendors and cross-functional support teams for the manufacture of different types of dosage forms, establishing clear timelines for goal attainment.

• Lead team members in the support of objectives setting, performance evaluations and development

planning discussions.

• Evaluate technologies and equipment and provide cost-savings, efficiency-improving recommendations to Formulation and Process Development Groups.

• Perform ongoing reviews of GMP documentation for operational and technical accuracy.

Scientist II, Formulation Development, 2005 – 2009

Designed, planned, performed, interpreted and reported results of scientific experiments for the preparation and timely delivery of drug substances (DS), drug products (DP), processes and procedures.

• Designed a systematic testing approach that enabled the completion of experiments and gathering of data in timely and logical order.

• Developed a stable formulation for a difficult-to-formulate active in a direct compression tablet dosage form, directly resulting from pre-formulation testing, compatibility studies, and innovative study design.

• Improved a high-volume gel formulation for an existing product, successfully scaling up and transferring equipment and achieving multi-million dollar cost savings.

• Lead the validation projects required to transfer or manufacture clinical supplies.

Scientist II, Marketed Product Development and Support, 2002 – 2004

Conducted research in the area of process improvement in support of innovative product development for the life-cycle management of marketed products.

• Managed scale up and scale down development projects involving product line extensions and reformulations.

• Prepared work plans and facilitated scientist teams to implement recommendations.

ANA MELÉNDEZ 770.***.**** ~ PAGE TWO



Validation Expert, Technical Operations, 2002 – 2002

Process Excellence Certified Black Belt, 2000 – 2002

Senior Scientist, Technical Operations, 1994 – 2001

Served as multi-functional Project Manager for Process Excellence projects in the Solids and Semi-Solids business units. Functioned as main point of contact for Plant Management executives.

• Led multidisciplinary validation teams using DMAIC tools for the evaluation of processes, packaging, cleaning, and equipment qualifications.

• Performed extensive process support work for the development of tablets (direct compression and wet granulation with solvents), emulsions, suspensions and gels.

• Managed work flow of scale up and scale down projects, and performed troubleshooting projects for both marketed and experimental products.

• Completed regular audits of operations, process, packaging and suppliers, gathering and reviewing data and ensuring that studies maintain operational compliance.

• Coordinated product transfers between sites, ensuring proper handling and timely departures and arrivals.

• Directed a process excellence project to improve the yield of a wet granulation product, saving the company approximately $250k annually.

BRISTOL-MYERS SQUIBB COMPANY, Barceloneta, PR 1993 – 1994

Validation Specialist

Developed and led teams in the execution of validation protocols for process support, troubleshooting, and reformulation projects for currently marketed or transferred products. Completed summary reports.

• Collaborated with cross-functional teams on project completion for solid dosage forms and APIs.

• Specialized in reconstitution projects involving and penicillin and cephalosporin products in tablet, capsule and powder form

• Managed validation schedules and activities by partnering with ERP / Production Department.


Master Degree, Industrial Pharmacy, Graduate School of Pharmacy, University of Puerto Rico,

Río Piedras, PR

Bachelor Degree, Pharmaceutical Sciences, School of Pharmacy, University of Puerto Rico

Río Piedras, PR

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