Ronnie Royal CV

Ronnie D. Royal

919-***-****

acvpcf@r.postjobfree.com

Summary of Qualification

Approximately 14 years of biotechnology industry experience, 8.5 years of which are hands-o n

experience in SOLID DOSE Manufacturing (Dispensing, Mixing, Compaction,

Granulation, and Compression). Over 2 years PLASMA FRACTIONATION processing.

Knowledge of batch manufacturing record (BMR), standard operating procedures (SOP’s) and cGMP. Also, over 3.5 years of PARENTERAL PILOT MANUFACTURING: Aseptic technique and processing.

Employment History

Associate III, Manufacturing 2015Present

Novartis (Sequirus), Holly Springs

Function as a key shop floor team member manufacturing high quality biologicals and sterile injectable.

• Clean, prepare and sterilize production equipment

• Clean and disinfect production rooms

• Assemble, set-up, and disassembly of production equipment

• Support qualification and validation activities

• Recognize and effectively troubleshooting atypical process issues

• Provide informal guidance and support to more junior team members to assist with problem solving and teamwork

Lead, Aseptic Technician 2014-2015

Eisai, Inc., Research Triangle Park

Acted as the Subject Matter Expert (SME) for the Designated Process Areas, was responsible for the functional integrity of assigned area Standard Operating Procedures (SOPs) and Master Batch Records (MBRs). Overall responsible for providing and directing operational and equipment problem(s) resolution during routine manufacturing operations.

• Established and maintained the functional integrity of Area SOPs and MBRs.

• Provided oversight and coaching to Aseptic Technicians (levels I, II, and Senior) during manufacturing operations to ensure adherence to SOPs and MBRs

• Provided first-line support and coordination for the resolution of equipment/process problems during routine production activities.

• Conducted Detailed Technical Reviews and coordinated the timely processing of MBRs and associated Reports and Documents

• Assisted in the acquisition and technical review of area and equipment performance trending and equipment alarms

• Coordinated lead activities that supported Technology Transfer, engineering, equipment validation and process improvements

• Provided training to Aseptic Technicians (Level I, II, and Senior) to help them achieve proficiency / certifications in area operations.

• Provided real-time, ongoing training and coaching for area production technicians regarding the implementation of these procedures and current Good Manufacturing Practices (cGMPs) and Techniques.

Sr. Aseptic Technician 2013-2014

Eisai, Inc., Research Triangle Park

Responsible maintaining an advanced level of knowledge/understanding of the current Good Manufacturing Practices (cGMP) and Parenteral Manufacturing / Operations and Practices. Trained junior Aseptic Technicians, and provided field leadership and guidance for all assigned production activities.

• Demonstrated independent operational proficiency on at least 3 Area Operations (e.g., Component Preparation, Portable Vessel(s) Preparation, Compounding, Filling, etc.).

• Provided general area support for assigned process operations; (e.g., Filling, Compounding, Filtration, Capping, etc.).

• Learned & demonstrated advanced understanding of cGMP, parenteral manufacturing, parenteral facility operations, and operating practices:

• Annual Proficiency Test Score was above 90%

• Developed and implemented Energy Isolation / Lock-Out Tag-Out (LOTO) Plans in support of maintenance activities.

• Initiated MAXIMO Work Orders for Maintenance Service Requests.

• Conducted first-line troubleshooting by obtaining and analyzing ParCS Trends.

• Provided operations support for Engineering, Technology Transfer, and Validation Activities.

• Participated in the management/execution of daily PF logistics activities, assigned on a periodic/rotational basis.

• Assisted in the scheduling and coordination of System/Area Production Operations.

• Acted as the S.M.E. / Owner of assigned Standard Operating Procedures (SOPs) and Area Operations (e.g., Component Preparation, Portable Vessel(s) Preparation, Compounding, Filling, Lyophilization, etc.), and be capable of providing field training to junior Aseptic Technicians.

• Provided Operations S.M.E. support for Deviation Investigations.

• Followed written instructions for all cGMP activities and be able to annotate instructions (under Line Management supervision) if procedural instructions require enhancements or improvements.

• Recognized when expected procedural outcomes were not achieved, or if equipment malfunctions or process anomalies have occurred, and notified area management of the relevant circumstances.

Aseptic Technician (Parenteral Pilot Plant) 2009-2013

Eisai, Inc., Research Triangle Park

• Participated in manufacturing process development and manufacture of experimental drug products under aseptic conditions and in accordance with US, EU and JP cGMPs.

• Cleaned, set-up, performed AP handling, decontamination activities and operated all equipment used in the Parenteral Pilot Plant for preparation of equipment/components used in Parenteral manufacturing (e.g., autoclaves, dry heat ovens, vial washers, cappers, filling machines, and semi-automated visual inspection equipment).

• Participated in all unit operations associated with Parenteral Manufacturing including dispensing, compounding, filtration, filling, lyophilization, capping and visual inspection.

• Assisted with documentation of all product and maintenance activities on the master batch record in compliance with GMP requirements. Also, assisted with CAPA actions and deviation analysis.

• Assisted in the development of operating procedures, forms, and specification.

• Presented a working knowledge of aseptic technique and processes

Manufacturing Technician 2001-2009

Eisai, Inc., Research Triangle Park

• Dispensed active and non-active raw materials, performed the following solid dose operations: Sifting, Granulation, Tablet compression, Blending, Mixing, Filling, Coating, and Packaging.

• Worked with in-process checking, line clearance and follow cGMP regulation in various stages in production.

• Assisted with daily SAP transactions, equipment cleaning, set-up, disassembly, and troubleshooting of equipment malfunctions.

• Operated equipment in accordance with cGMPs, batch documents, sops, OSHA standards and safety policies.

• Assisted Lead Technician in the planning and scheduling daily project activities and resources

• Mentored and trained less experience employees and temporary staff on processes.

• Worked with department on the development, implementation, and monitoring of adherence to CGMP and departmental standard operating procedures.

United States National Guard 1982-1985

Clayton High School, Diploma 1982

Continuing Education/Training

Wake Technical Community College

Completed training in:

• Welding: Practical Certification, March 2009

• Bioworks Mechanics Training Certification, January 2008

• Elements of Aseptic Manufacturing Level 1 Certification, December 2007

• Elements of Aseptic Manufacturing Level 2 Certification July 2008

• Computer Keyboarding Certification July 2008

• Microsoft Word Certification June 2008

• Introduction to Excel Certification September 2008

• Work Keys Mechanical Testing

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