1. Michael E Gable
581 Boysenberry Lane
Frederick, MD 21703
Telephone: (240)446-1943 email:edgable68@gmail.com
Related Work Experience
MedImmune, Inc. Frederick, MD
Lead Tech 2015 to present
Formulation - downstream
• Qualified in Prod Tech III duties
• Assigning daily tasks to production technicians pertaining to manufacture of
biological based products
• Complete manufacturing documentation per approved procedures Includes reviewing
documentation for completeness and accuracy per established timelines
• Act as qualified trainer of those with less experience.
• In-direct supervision of production technicians.
• Provides input into annual performance evaluations of production technicians as
applicable.
• Investigate and resolve problems. Clear and concise communication to
Supervision/Management
• Coordination of production tasks to meet assigned schedule
• Other duties as assigned or identified
Production Technician III 2003 to 2015
Cell Culture – Purification
• cGMP production of a commercially available monoclonal antibody.
• Purification techniques: Chromatography (ion exchange, affinity), Nanofiltration, and
Tangential Flow Filtration/Ultrafiltration, Bulk Freeze Operations, Column Packing.
• CIP, SIP of process vessels and transfer lines.
• Managing logbooks/SOP’s and database
• Purification safety committee representative.
• Bulk Freeze Operations for the clinical operations Included revising generic MPR’s
for freeze opertions, getting 636 up and operational
• Interaction between departments to meet the work schedule goals.
• Start up of a new Facility 633. I was part of the CIP Team and assisted with recipe
development. Worked with Validation on the SIP Team to get tanks, viral skids, etc
commissioned for processing.
• SAP, LIMS, Aegis, Track Wise trained

2. Production Technician II 2001 - 2003
Plasma Production
• Fractionated plasma into various components using a large-scale centrifuge.
• Maintained freezer chart recorders.
• Performed as area supervisor when needed.
Life Technologies, Inc
Frederick, MD
Inventory Control Specialist 1998 –
2001
• Responsible for ordering, organizing, and maintaining office and lab supply inventory
for department utilizing outside vendors and internal warehouse.
Assigned product inventories to pending work orders.
• Performed cycle counts to assure inventory accuracy.
• Received and inspected incoming products and placed them in the proper storage
areas and maintained an electronic database.
• Communicated supply issues to both Purchasing and Manufacturing departments.
Laboratory Technician 1993 –
1998
• Responsible for filling, labeling and packaging products according to established
SOPs and cGMPs.
• Used computerized automated product packaging and labeling system.
• Responsible for clean room product control.
• Responsible for resolution of Hazardous Waste and Safety issues.
Education 1987 - 1988
Allegheny Community College
General Studies
Relevant training / courses
- Seminars attended : GM Healthcare ”LEAN” webinar , Managing Multiple.
Projects and Deadlines, Microsoft Excel Course, Confined Space Training.
- Career Development Training: Career Architect Training, Self Situational
Leadership Training