Drew Millette

**** *. ***** **** *** ***

Durham, NC 27703

336-***-**** acf5x8@r.postjobfree.com

OBJECTIVE

To combine significant scientific and GLP knowledge base with pharmaceutical industry leading Quality

Assurance experience to ensure compliance at Park Hudson International Raleigh site

QUALIFICATIONS

1.5+ years of pharmaceutical experience performing Quality Assurance in cGMP pharmaceutical

manufacturing facility

3.5+ years of GLP experience working with bioanalytical methods such as Quantitative Real-

Time PCR, ELISA immunoassays, Western blotting, RNA extractions, protein extractions,

reverse transcription protocols for cDNA synthesis, mouse colony management, tissue harvest,

mammalian cell culture maintenance, viral proliferation experimentation (HSV-1, Adenovirus,

influenza, coxsackie virus), among others

Full working knowledge of FDA, EU, and international regulations

EDUCATION

University of North Carolina at Chapel Hill

M.S., Nutrition (Nutritional Biochemistry), 2012

Master’s thesis: “Short-term Feeding Effects of High-Fat Diet on Hippocampal Neuroinflammation:

Differences among C57BL/6J, C3H/HeN, and C3H/HeJ mice.”

University of North Carolina at Chapel Hill

B.S., Biology, 2009

Minor in Chemistry and Music

RELEVANT EXPERIENCE

Merck Manufacturing Division – Durham Feb 2013 – Present

Durham, NC

The Maurice R. Hilleman Center for Vaccine Manufacturing

Quality Assurance Associate Specialist (Contract) that reviews vaccine manufacturing orders in

accordance to FDA regulations, analyze Electronic Batch Record (EBR) for documentation errors

ensuring proper current good manufacturing practices (cGMPs) and safety of vaccines prior to release,

and Subject Matter Expert in Quality batch record review for several shop floor orders

Ensure efficient production control of Varivax, Zostavax, Measles, Mumps and Rubella (MMR)

vaccines, and Harvest Viral Fluid (Concentrated 2X Bulk Varicella)

Review and approve integrated batch data from automated systems (DeltaV, RtReports, PAS-X –

MES EBR, LIMS, SAP, and MIDAS)

Support Operations to resolve errors and issues pertaining to documentation and batch execution

Improve communications between Operations and Quality units through Kaizen events

Train fellow employees to complete tasks according to Merck Quality guidelines and site SOP’s

Author investigation memos/Quality Notifications that drove CAPAs for process improvement

Revise Quality department SOPs for conducting Quality batch record review and integrate error

trending as part of performance metric tracking

Thorough understanding of FDA regulations including CFR 21 part 11

Drew Millette

5480 S. Miami Blvd Apt 204

Durham, NC 27703

336-***-**** acf5x8@r.postjobfree.com

UNC Gillings School of Global Public Health Chapel Hill, NC 2010-2012

Graduate Research Lab Technician

Conducted original research under the supervision of Dr. Patricia Sheridan in the Department of Nutrition

regarding the role of Toll-like Receptor 4 (TLR-4) in high fat diet-induced neuroinflammation.

Perform Quantitative Real-Time PCR, ELISA assays, RNA and protein extractions

Manage mouse colonies, mammalian cell cultures, and tissue harvests

Developed laboratory protocols decreasing experimental costs as well as increasing the reliability

and efficiency of data

Experienced in BSL-2 immunology/virology environment involving H1N1 influenza, Coxsackie

virus, Adenovirus, and HSV-1 as part of Melinda Beck lab (UNC-CH)

Conducted thorough literature reviews in experimental design development

Lead departmental talks on ongoing research within Sheridan/Beck lab

2008 – 2009

UNC Lineberger Comprehensive Cancer Center Chapel Hill, NC

Research Lab Technician

Researched the effect of re-expression of the SNF5 tumor suppressor gene, part of SWI/SNF chromatin

remodeling complex, on malignant rhabdoid tumor cell growth. Worked under Dr. Bernard Weissman in

the Department of Pathology and Laboratory Medicine.

Skilled in quantitative real-time PCR, Western blots, RNA extractions, protein extractions

Maintain cancer cell cultures and performed adenoviral infections for SNF5 re-expression

HONORS

Dean’s List (4 terms)

ZBT Academic Excellence and Leadership (2007)

LEADERSHIP EXPERIENCE

Founding Father of Zeta Beta Tau Chapter (UNC Alpha Pi)

Residence Hall Association Community Government (OCLQ) 2006-2007

Stacy Hall President 2005-2006

Olde Campus Lower Quad Activities Coordinator

Tae Kwan Do instructor (3rd degree Black Belt)

SKILLS

Proficient in French (intermediate level)

Experienced in current Good Manufacturing Practices (cGMPs), Good Documentation Practices

(GDP), and Good Laboratory Practices (GLPs)

Train the Trainer Certified (DTCC)

Microsoft Office applications (Word, Excel, PowerPoint, Outlook, Access)

Proficient in utilizing MES PAS –X, SAP, RtReports, LIMS, MIDAS (documentation

repository), and GSS spreadsheets

Experienced with JMP statistical software and GraphPad Prism (data publishing software)

Contact this candidate