Manufacturing High School

Michael Klug

*** ****** ****, *-**, Greenville, Rhode Island 02828

401-***-**** ********@***.***

Summary

Manufacturing Professional with extensive experience mainly in Bio-tech

and pharmaceutical environments. Has a broad range of experience and in

depth understanding of various functions of bio-tech manufacturing,

engineering, data management, and operational excellence. Known for a

relentless drive to complete the task at hand, keeping safety, quality, and

the production schedule as top priorities.

Professional Experience

IMMUNOGEN INC., Norwood, MA (Contract)

2014-Present

Engineer Manufacturing Science and Technology (Feb.2014-Present)

. Support data mining through data collection and compliation from

excuted records for internal and external manufacturing processes.

. Lead expirmentation for buffers and raw materials for technology

transfer.

. Assist in the execution of process validation studies.

. Responsible for general laboratory organization and maintaining the

readiness for non-GMP production activities.

LONZA BIOLOGICS, Hopkinton, MA

2008-2013

Manufacturing Science and Technology Assistant (Sep.2012-Sep.2013)

. Organized, edited and centralized manufacturing data spreadsheets for

over 15 different customers.

. Participated as a key member of a team that instituted the Global Data

Management System (a 9 month project), entering and verifying data.

. Supported manufacturing in entering and verifying real time data into

GDM.

. Piloted a project to obtain quality control data pre-LIMS, from

manufacturing batch records and solution documents and entered it into

LIMS.

. Assisted engineers in obtaining and verifying data to close

deviations, capa's and change controls.

. Systems Knowledge: SAP (Inventory control), Track Wise (deviations,

CAPAs, and Change Control), DMS (Document Management System), LIMS

(Laboratory Information Management System), Delta V (Plant operating

system), GDM and Statistica (data management and monitoring).

. In depth knowledge of Microsoft Office, Excel.

Purification Associate (Feb.2012-Sep.2012)

. Performed Purification operations, TFF, UF/DF, Column Chromatography

and Final Formulation.

. Executed and documented all activities in compliance to cGMP.

. Performed operation and minor maintenance of manufacturing equipment.

. In depth cGMP regulatory knowledge.

Senior Manufacturing / Lead Associate Central Services (Jan.2008-Feb.2012)

. Preparation of manufacturing equipment CIP's, SIP's, glass wash and

autoclave.

. Large and small scale media and buffer preparation in support of

manufacturing.

. Responsible for leading five associates in media and buffer

preparation as acting supervisor.

. Revised and maintained the solution schedules.

. Created, reviewed, and approved SOP's, Solution Documents and

Manufacturing Batch Records.

. As a qualified trainer, trained manufacturing associates using

performance measures.

. Experience in equipment, process validation and start up activities

. Proactive approach, action orientated with the ability to effectively

solve problems.

. Ability to effectively and professionally communicate with all

departments and all levels of personnel within the site.

. Flexibility to adapt to a fast moving environment.

AMGEN, West Greenwich, RI

2006-2008

Manufacturing Associate Buffer Preparation

. Buffer preparation in support of manufacturing.

. In cGMP clean room environment, manufactured buffers used in the

purification of bio-pharmaceutical products.

. Duties included equipment preparation, CIP's and SIP's glass wash and

autoclave.

. Knowledge of the Delta V Operating System.

. Duties included maintaining job scheduling and resource inventory, using

Werum and Enterprise Resource Planning programs.

. Hazmat, Incident Commander and National Incident Management System

trained.

RHODES TECHNOLOGY, Coventry, RI

1998-2006

Chemical Technician

. Under a cGMP and DEA environment, executed a variety of chemical

processing functions, including ordering and handling raw materials,

weighing, mixing, distilling, crystallizing, filtering, and centrifuging

of active pharmaceutical ingredients, using Delta V operating system.

. Duties included the writing and implementation of standard operating

procedures and process batch records.

. Operated reactors, centrifuges, dryers and micronizing equipment.

TRAINING/EDUCATION

. GMP normative in Pharmaceutical Industry at Lonza

. Train the Trainer at Lonza - Classroom and Performance Measures.

. Basic Skills Training at Amgen - month-long course in Bio-tech

processing and skills.

. Became certified as a first Responder, Hazmat and Incident Commander.

. Served for two years in the United States Air Force - Honorable

Discharge.

. High School Diploma, Brick High School, Brick NJ-College Prep.

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