Quality Assurance Sales

* ******* ******, *****, ** *****

Phone: 603-***-**** email: ***********@*****.***

DALE E. ZAJAC

Education: Associates of Science: Biotechnology, 2012 Great Bay

Community College

Biomedical Science, Laboratory Science University

of New Hampshire

Work

Experience: Pfizer April 2013- Present

Clinical- Scientific Process Development Technician - Purification

. cGMP manufacture of clinical and commercial drug substance.

. Troubleshooting of process disturbances and mechanical

equipment, identifying resolution and implementing corrective

and preventative measures as required.

. Perform clear and concise documentation following relevant SOPs

and electronic instructions.

. Interpreting chromatograms to trend and analyze protein

concentration and retention.

. Inventory tracking and consumption through SAP and AMPS

. Set up, operation, troubleshooting, and cleaning of

chromatography columns and skids, DF/UF, CIP skids and virus

filtration systems.

. Medical Response team trained and certified.

Moderna Messenger Therapeutics

Research Associate January 2013-April

2013

. Protein extraction and purification of in vitro and in vivo

samples.

. Quantification of proteins through biochemical assays.

. Protein detection through Western Blots and ELISA.

. Cell culture and transfection of mammalian cells.

. Quality assurance of transfection and assay improvement.

. Maintaining cell lines. Amplification of DNA through qPCR

Lindt and Sprungli, Stratham, NH June 2012- April

2013

Business to Business Material Specialist, Manufacturing/

Warehouse

. Fulfilling and prioritizing specialty business orders.

. Packaging products per cGMP guidelines. Shipping orders per federal

guidelines

. Following SOP's and filling out batch records.

. Generating an inventory list, picking stock from appropriate location

and lot number.

. Verifying stock was received and moving product to appropriate

department.

NH INBRE with Dartmouth College January 2012-

September 2012

Research Assistant

Process development of upstream processing of recombinant

yeast cells in a bioreactor

. Synthesizing patented human lysozyme for the treatment of cystic

fibrosis under cGMP guidelines.

. Growing, Monitoring and trending various species of yeast cells

for optimal outcome of proteins.

. Testing quality and quantity of protein using SDS PAGE and

ELISA.

. Development of assays, SOPs and batch records.

. Downstream processing of synthesized protein with use of UF/DF and

GE Unicorn FPLC

UNH Project

. Upstream processing of E coli for the production of v-src to

induce tumors in chickens

. Plasmid prep to isolate v-src

RadioShack Corporation, Somersworth, NH November 2007-

June 2012

Assistant Manager

. Maintaining store function, profitability and quarterly

goals

. Trouble shooting electronics

. Following dedicated sales path to maintain profitability

and strict sales goals

. Addressing customers concerns and needs in a

professional manner.

Additional Proficient in Microsoft Office, Visual Basic and Networking,

Hardware troubleshooting Training: and basic repair of motherboards.

First aid, klCPR. Archery and COPE director of BSA

Extracurricular Treasurer-Class of 2010, Habitat for Humanity, Dover

men's lacrosse,

Skills: cGMP, GLP, OSHA

. Reading and following SOPs, completing batch and training records

. Media and Buffer Preparation

. Proper clean room conduct and gowning.

. Aseptic Technique

. Upstream processing of recombinant bacterial, mammalian, and

yeast cells in shake,flasks, spinners flasks and a bioreactor.

Generation of growth curves using optical density, and viable

cell counts

. DNA isolation, gene mapping,DNA fingerprinting, gene cloning,

gene expression regulation, AGE (with/without Ethidium Bromide),

Southern Blotting RFLP, Northern Blotting, Western blotting cDNA

synthesis from RNA, PCR, mRNA isolation, gene library production

and gene sequencing

. Downstream processing including tangential flow filtration (TFF),

and chromatography: hydrophobic interaction (HIC), ion exchange

chromatography and affinity chromatography.

. QC: ELISA, SDS PAGE, Activity Assays, Gram staining, LAL and

mycoplasma detection assays

. Knowledge of microbiology media; including selective, growth and

differential.

. Various Laboratory equipment use: Including Level II Bio-safety

cabinet, Autoclave, CO2 Incubator, balances, centrifuges, plate

reader, hybridization ovens, pH meters, spectrophotometer, HPLC,

FPLC.

Lab

Experience:

. Producing a batch culture of recombinant mammalian, yeast and

bacterial host cells. Growing batch, fed batch, and continuous

cell cultures. Tracking and analyzing growth with chromatograms.

. Gowning for entry in a bio manufacturing suite.

. Testing of membrane integrity of various filters

. Using a variety of bioreactors to grow, monitor and trend cell

cultures.

. Monitoring cell viability with the use of Trypan Blue.

. Transfection of mammalian cells.

. Mammalian cell culture

. Concentration and buffer exchange of protein products using

tangential flow and diafiltration processes.

. Use of affinity, hydrophobic interaction and ion exchange column

chromatography in an HPLC and FPLC.

. Using four step gram stains, selective and differential media as

well as chemical test to identify microorganisms.

. LAL assays to determine the endotoxin concentration.

. Testing of media and cultures for the presence of mycoplasma.

. Determining the concentration of a protein by use of ELISA and

competitive ELISA.

. Extracting, spooling, and quantifying DNA from tissues.

. DNA fingerprinting of DNA using southern blotting and probe

hybridization

. Using PCR to amplify DNA.

. Using PCR to amplify a short nucleotide sequence from human

chromosomes to create a personal DNA fingerprint

and observe single nucleotide polymorphisms.

. Gene silencing of organisms by induction of RNA.

. Preparation of extracts from various organisms to discover an

antimicrobial agent. Isolating and amplifying the gene

responsible antimicrobial activity and using an activity assays

to measure the strength.

. Building a genomic library for various organisms.

. Isolating plasmid DNA from various bacteria. Cutting the DNA to

verify that the plasmid contains an insert from the genomic DNA

preparation. Sequencing the DNA and using a blast search to

determine the gene that was cloned.

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