Business Development Operational Excellence

ROSANNA PECIREP

Cleveland, OH ***** 440-***-**** *******@***.*** linkedin.com/in/rosanna-pecirep-lanza-5120309 PHARMACEUTICAL PROCESS SPECIALIST

Reliable Pharmaceutical Specialist with a rich history of propelling startups to success through operational excellence. Cultivates effective cross-functional relationships to enable seamless collaboration and easy dissemination of information. Excellent regulatory compliance experience with a history of passing critical FDA inspections. AREAS OF EXPERTISE

Marketing/Sales Startup Founder Event Management Business Development Process Improvement Operational Excellence Project Coordination Data Analysis Root Cause Analysis FDA Regulations PROFESSIONAL EXPERIENCE

Xellia Pharmaceuticals, Cleveland, OH December 2019 – October 2024 Aseptic Operations Specialist III

First of hire of sterile manufacturing of injectable drugs. Ensured protocols were carried out in controlled environments.

• Played instrumental role in developing and defining manufacturing start-up tasks from project mode to commercial success.

• Pioneered development all drug manufacturing processes, wrote standard operating procedures (SOPs), logbooks, and work instructions.

• Monitored product contact equipment in sterile processing areas, parts washing, autoclaving, filter testing, compounding, filling, and training.

• Developed team members for contributions and achievements, leading to improved morale and successful market deliverables.

• Educated and partnered with Marketing, Sales, and Packaging teams to create pharmaceutical trade show materials, allowing for a unique, accurate connection with potential buyers and the drug creators. Collaborated on videos and photography for training and marketing purposes.

• Acted as incoming MQA for the sterile IV bag line, secured all raw materials, containers, closures, and packaging materials to ensure sterility, from incoming quality assurance to decommissioning.

• Subject Matter Expert on aseptic techniques and working in a clean room environment.

• Established best practices, SOPs and current good manufacturing practices (cGMPs), leading to FDA pre- approval.

Gipsco Investment Group/Lee Silsby Compounding November 2006 - November 2019 Sterile Compounding IV Specialist

Responsible for overall functions of sterile preparation, compounding in a clean room, and isolator filling activities.

• Analyzed data and research to formulate investigational and clinical trial drugs.

• Worked mostly independently in an extremely busy environment, ensuring accurate, safe products.

• Played crucial role in intense FDA inspections during and after moving to a new facility with new pharmacy reclassification. Resulted in being upgraded to a premier 503A Compounding Pharmacy. ADDITIONAL RELEVANT EXPERIENCE

Mobile Medical Corporation, Rocky River, OH May 2005- November 2006 Lead Mobile Technician

Responsible for traveling to sites to obtain samples in a clinical manner, demonstrating chain of custody and documentation.

• Acquired and completed laboratory testing of samples and documented confirmation of results.

• Trained and utilized Root Cause Analysis, Medical Assisting, and HIPAA to ensure patient safety. Wright Consulting, Inc, Beachwood, Ohio February 2002-May 2003 Regional Program Manager

Responsible for audit, compliance, training and logistics of local and nationwide Fortune 500 marketing assignments. Started as a brand ambassador and spokesmodel, interactions were a key to successful promotions. Relentless Merchandise, LLC November 2000- present Owner/Founder/Artist

Thriving art and multimedia small business, started after apprenticeships with local print and digital artists. Continues to be a successful side hustle. Responsible for design, labor, content creation, event planning, and marketing for curated fine arts festivals.

EDUCATION

Bachelor of Applied Science, BASc, Environmental Biology Summa Cum Laude President’s List NSLS Honors Society University of Phoenix

IV and Clinical Technology Certificate Certificate, Medical Assisting, Aseptic Technique, and Laboratory Processing CERTIFICATIONS

Certified Pharmacy Technician (CPhT) Six Sigma 5S Certified Gold-Certified Travel Agent, Specialty Wellness Travel Project Management (PMP)/Scrum Project Delivery

Certified and registered in Ohio and Texas for IV and Sterile Processing

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