Technician Quality Control

Stephen K Atencio

*** **** ***** *****

Apex, NC 27539

Cell: 978-***-****

Email: **************@*****.***

OBJECTIVE

To obtain a senior position in the Pharmaceutical or Medical Device

field offering a challenging, personal growth, and responsibility.

QUALIFICATIONS

. Extensive knowledge in Biotechnology working as a Senior Process

Technician in protein purification for over 20 years

. Successfully led the launch of manufacturing of three commercial

drug campaigns:

o rhBMP

o r AHF

o r FIX

. Experienced in clean room environment - aseptic techniques and

cGMP's

. Lead site start up operations at several organizations

. Excellent interpersonal and communication skills

. Yellow Belt certified in Lean Manufacturing 6 Sigma, 5 S, and

Operational Excellence

COMPUTER SKILLS

Microsoft Word & Excel, LIMS, SAP, Track Wise, Delta V, Atlas EDMS

EXPERIENCE

03/14 to 09/14 Biogen Idec (Kelly Scientific Contractor)

RTP, North Carolina

Manufacturing Associate

. Training in the 2K Cell Culture area

. Media Preparation and Filtration

. Aseptic Operations in BSC or Fume Hood

. Operating Delta-V controlled Bioreactors and Process Vessels

. Operate Clean-in-Place (CIP) and Steam-in-place (SIP) Systems

08/11 to 03/2014 Novartis Vaccines & Diagnostics Holly

Springs, NC

Sr. Manufacturing Technician III

. Trained staff on various pieces of equipment from Columns,

UF/DF systems, bench top equipment, etc

. Redlined production documentation and incorporated changes to

SOPs and BPRs

. Participated in Cleaning Validation and aligned area Clean In

Place procedures

. Experience using process and business management software

including Delta V (HMI), SAP, LIMS, Maximo, Sentry, Track

Wise, Atlas EDMS, Share-Point, and Microsoft Office Suite

. Served as a Downstream Purification Qualified Trainer,

coaching new employees on production processes and cGMPs

. Recognized for Outstanding Contributions during Process

Engineering and Process Validation, and commercial cGMP Runs

11/10 to 8/11 Sanofi Pasteur Canton,

MA

Manufacturing Associate III

. Perform Upstream and Downstream processing using one or more

of the following unit-processing steps:

. Bioreactor Operations

. Tangential Flow Filtration

. Depth Filtration

. Media Preparation and filtration

. Operate Clean-in-Place (CIP) and Steam-in-place (SIP) Systems

. Perform Mammalian cell culture and sampling operations using

aseptic technique

. Operate general production equipment such as Autoclaves,

Incubators, pH/Conductivity meters

. Document and maintain production activity records according

to cGMP regulations

. Perform other duties as assigned

2/09 to 11/10 Lonza

Hopkinton, MA

Lead Manufacturing Technician

. Contributed to facility start-up

. Experienced in DELTA-V operating system

. Operation of large and small scale UF skids

. Maintain inventory control of processing supplies

. Perform Aseptic sampling

. Write and revise Standard Operating Procedures (SOP)

. Assist in validation (IQ, OQ, PQ)

12/06 to 2/09 Shire Hgt Inc

Cambridge, MA

Sr. Manufacturing Technician II

. Responsible for the Ultra-filtration Drug Processing

applications for the Cell Culture Manufacturing group

. Operation of the UF-1604 and UF-4300 skids

. Maintain inventory control of processing supplies

. Perform Aseptic sampling

. Write and revise Standard Operating Procedures (SOP)

. Assist in validation (IQ, OQ, PQ)

. Worked on multiple drug products (Replagal, Idurasulphase,

GCB)

1/06 to 11/06 Acusphere Inc

Tewksbury, MA

Manufacturing Specialist

. Responsible for the Drug Processing applications for the AI-

700 project including, but not limited to (Dispensing,

Compounding, Filtration,

Aseptic Filling, Lyophilizing, and Final Inspection)

. Wrote and revised numerous SOP's

. Assisted in validation (IQ, OQ, PQ)

4/02 to 12/05 Abbott Bioresearch Center

Worcester, MA

Sr. Process Technician II

. Responsible for the protein purification operations for the

D2E7 project

. Part of a team that lead to the FDA approval of D2E7(Humira)

project

. Trained new employees on basic cGMP requirements, CIP/SIP

vessels, product sampling, aseptic techniques

. Revised numerous SOP's contributing to process improvements

2/00 to 11/01 Pharm-Eco Labs, Inc./Upt North

Andover, MA

Sr. Production Technician

. Learned how to operate SMB (Simulated Moving Bed) technology

. Operation of analytical HPLCs and the setup and operation of

dynamic axial compression columns (DAC)

. Executing validation protocols

. SOP and Batch record writing and revising

7/99 to 2/00 Pall Filtron

Northboro, MA

Quality Control Supervisor

. Responsible for the disposition of filter membrane and

coordinating work flow for high volume manufacturing

processes

. Production planning and inventory controls as well as

overseeing day to day activities of the Quality Control

laboratory and several QC Technicians

. SOP writing and issuing of Certificates of Compliance

12/98 to 2/99 Merck-Medco Rx Services Las

Vegas, NV

Quality Assurance Technician

. Performed internal audits, Incoming Inspection on all non-

drug materials

. Conducted investigations on external non-conformance reports

. Executed protocol validations on automated equipment (IQ, OQ,

PQ)

. SOP revisions

10/92 to 11/98 Genetics Institute

Andover, MA

Process Technician

. Responsible for the manufacture of protein through liquid

chromatography systems and day to day operations of a

commercially licensed FDA facility

. Trained in aseptic techniques, cGMP's

. Wrote and revised numerous SOP's

EDUCATION

Wake Technical Community College Raleigh, NC

Biotechnology Certificate Program

. Fundamentals of Cleaning Validation

. Cell Culture Processes

. Chromatography in Theory and Practice

. Basic Concepts of Validation

Middlesex Community College (95% on Massachusetts Civil Service

Policy Exam) Criminal Justice

1985

Diploma Lowell High School (Honors - College Oriented Courses)

1983

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