Jonathan M. Ley

***** ****** ****** **********, ** 90706 610-***-**** acci0n@r.postjobfree.com

PROFILE

• Strong research, planning, and organization skills

• Excellent written and oral communicating skills

• Over four years of experience working in a cGMP environment

• A self-motivated professional with a versatile skill set in both the Bio-Pharmaceutical Industry and the Information Technology

Industry

EXPERIENCE

Auxilium Pharmaceuticals, Inc. Horsham, PA

Manufacturing Associate II - Support June 2009 – September 2013

• Perform production support activities for the manufacturing and validation of Xiaflex drug substance

• Provide schedules for buffer preparation, autoclave operations, clean equipment and parts

• Create/revise/review/approve SOPs, Validation Protocols, IOPQs, logbooks, and GMP forms

• Prepare buffers and media for purification and fermentation production steps as per manufacturing schedules

• Assemble, clean, and sterilize production equipment using autoclaves, CIP, SIP and/or glassware washer technology

• Trend production data associated with buffer/media for each processing batch

• Experienced working in a cGMP environment

• Support and complete routine validation on equipment, processes, and utilities

• Assist in the resolution of manufacturing deviations/non-conformances, troubleshooting processes, and equipment/computer

related issues.

• Experience working in ISO 5, 7, 8

• Trained associates in aseptic techniques and yearly aseptic qualifications.

• Ensure manufacturing operations are maintained in compliance with all applicable regulations, guidelines and safety policies

and procedures

• Review of batch records and verify SAP transactions for materials received and used during process

• Cross-trained with the Fermentation and Purification group to better understand their processes

Market Research Partners Philadelphia, PA

Data Analyst July 2008 – Jun 2009

• Prioritize work for the Data Management team, analyzing business needs and priorities for upcoming campaigns

• Used programs such as SSIS and Management Studio to help generate lists to be used by account executives

• Analyze database to identify possible organizations for upcoming marketing campaigns

• Perform SQL queries and integration services jobs to extract and normalize lists and databases

• Assisted help desk support team with new software implementations

LaFrance Corporation Concordville, PA

Help Desk Technician (Temporary) April 2008- June 2008

• Supported users in both hardware and software related issues

• Managed and maintained companies inventory of desktop, laptops, and devices

• Train new hires on software used within the company

EDUCATION

Drexel University Philadelphia, PA

Bachelor of Science in Information Systems 2005-2008

Minor: Business Administration GPA 3.14

COMPUTER SKILLS

Operating Systems: Microsoft Windows 98-Windows 7, OS X

Software: Microsoft Office, Microsoft Visual Studio, Oracle, SQL Navigator, SQL Server Reporting, Livelink eCMS, TrackWise, SAP

Netweaver

CERTIFICATE

Technical Writing Springhouse Education & Consulting Services, PA April 2013

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