Quality Control Manufacturing

Stuart John Yates, BS in Chemistry

*** * **** **, *******, CO 80305

847-***-**** ***.*****@*****.***

Summary

Versatile chemist with 3 years experience in Quality Control and R&D. I believe my

background in API manufacturing, both in Quality and Process Development, as

well as my background in Nucleotide Synthesis, would make me an outstanding

candidate for a position supporting manufacturing in a fast-paced oligonucleotide

API facility.

Core Competencies

• Experienced in Manufacturing Process Development in Biopharmaceuticals

• Extensive experience working with Nucleotide Chemistry, having developed

assays and impurity tests using techniques such as EL ISA, staining/blotting,

and SEC

• H ighly skilled in HPLC, GC, ICP, MS, UV/VIS, FT-IR in GMP environment

• Strong wri t ten and verbal skills; highly skilled in Excel, Word, Powerpoint

Work Experience

Analytical Chemist October 2012 – present

Hospira, Inc.

Boulder, CO

As a member of the Quality Control team, my chief responsibili ty is

ensuring testing of in-process samples is completed in a timely manner

to support 24/7 API manufacturing. My background and interest in

manufacturing process development also helped me greatly to

u nderstand the challenges of API manufacturing to achieve site goals.

• QC Analyst

Consistently set department-leading tu rnaround t imes for sample

analysis

Demonstrated strong ability to set up, run, and t roubleshoot HPLC

methods, and resourcefulness when identifying and fixing method

issues

Created and implemented systems to improve communication between

manufacturing and QC and within QC, while also providing a platform

to t rack and t rend sample tu rnaround times and map QC workflows

Graduate Research Assistant M ay 2011 – June 2012

Center for Innovation in Engineering & Science Education (CIESE)

Stevens Institu te of Technology, Hoboken, NJ

As a graduate researcher, I co-designed and ran a graduate-level

p rofessional development course on energy production & consumption for

44 elementary and middle school teachers across New Jersey over the

Summer of 2011. I then evaluated and analyzed all assessments and

other course materials for research purposes, and collaborated on

conference papers to present findings.

R&D Chemist August 2009 – January 2011

Hemispherx Biopharma, Inc.

New Brunswick, NJ

As an R&D chemist, I designed 2 release assays to meet FDA

requirements in a cost-effective way, drawing upon current li terature

and working entirely self-directed. As R&D support for manufacturing, I

worked with a team to design and optimize of a novel, scaleable

b ioreactor process for manufacture of human leukocyte-derived IFN- α

d rug product. Each week, I planned, facilitated, coordinated, and

carried out experiments, then gathered, analyzed, and presented data

and compiled the development report for the project.

• R&D – Assay Method Development

Developed assays for quantification of abasic sites in dsRNA drug

A mpligen using an EL ISA-like assay, and qualification of RNase

d igestion of Ampligen using agarose gel electrophoresis and acridine

orange f luorescent staining

Wrote full pre-validation reports for both assays

Developed bioassay for binding of Ampligen to TLR-3 receptor using

SEC

• R&D – Manufacturing Process Development

Worked with a team comprised of QC, QA, R&D and manufacturing to

develop a novel, scalable bioreactor process for manufacture of human

leukocyte-derived in terferon drug Alferon

Responsible for planning, execution, analysis, presentation, and

w ri ting of development report for benchtop-scale bioreactor

experiments, as well as researching and ordering of new hardware

• Quali ty Control

Assisted QC with method validation and analysis of stability samples

Troubleshooting of instrumentation and analytical methods

Education

BSc in Chemistry September 2004 – December 2008

University of Bath, United Kingdom

MS in Chemistry January 2011 – present

Stevens Institute of Technology, Hoboken, NJ

Publications

Bonne, M. J., Reynolds, C., Yates, S., Shul, G., Niedziolka, J., Opallo, M. and Marken,

F., 2006. The electrochemical ion-t ransfer reactivity of porphyrinato metal complexes in

4-(3-phenylpropyl)pyridine vertical bar water systems. New Journal of Chemistry, 30 (3),

pp. 327-334.

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