Development Design

Mary Belfast

Assay Development, Validation and Transfer

*****@**********.***

Summary

Biotech-savvy senior research biochemist with 15+ years research and development (R&D) experience in

pre-clinical and process development. SME for assay development, validation and transfer of immunoassays,

biochemical and in vivo methods supporting vaccines and biologics in a wide range of laboratory settings.

Championed experimental design for assay/process troubleshooting and validation. Results-driven leader, with

cross-departmental R&D project integration. Adept in CRO outsourcing, hiring, and management.

CORE COMPETENCIES:

Pre-Clinical & Process Development Projects

Streamlining and Automating Systems

Project Management

cGMP / GLP Regulatory Compliance

Regulatory Support (Nonclinical)

SPECIALTIES:

In vitro and In vivo assay development, troubleshooting, validation and transfer

Experimental Design (DOE)

HPLC (HPAEC-PAD, HPSEC, rpHPLC) Methods and Technology

EIA/ELISA Immunological Methods and Technology

Robotic Systems (Hamilton, Tecan, Beckman-Coulter)

Antibody Production

Experience

Scientist at Merck and Company

April 1997 - December 2013 (16 years 9 months)

Hired from temp-to-perm position to perform established testing for pre-clinical release and stability of

pediatric vaccines. Advanced to manger of a microCT core technology area supporting phase III/NDA of late

stage molecules. Experience in planning and supervising complex research, regulatory, administrative, and

technical activities in cGMP environment. Provided cross-functional support to research and manufacturing

areas in addition to external projects. Supervisor experience includes contingency workers, interns and a 30

member auxiliary staff.

Associate Principal Scientist, Bone Biology, Basic Research (2010 to 2013)

Page1

Transferred post-reorganization and tasked with management of microCT core technology group for

evaluation of microarchtecture in the bone established testing priorities, developed electronic storage of

imaging files, supervision of summer intern and writing SOPs, training manuals, and technical reports.

Senior Research Biochemist, Reagent Generation Group, Basic Research (2008 to 2010)

Transferred post-reorganization and charged with leading therapeutic polyclonal antibody development for

internal customers’ use in anti-drug antibody (ADA) assays to support therapeutic proteins development

encompassing monoclonal antibodies, protein and peptide targets.

Research Chemist, Combination Vaccine Development Group, Bioprocess R&D, (2000 to 2005)

Promoted to plan and supervise complex research, regulatory, administrative, and technical activities in

cGMP environment. Expedited development, validation, and transfer of assays measuring antigen levels in

vaccines. Established in vivo and in vitro models to support impact of process changes on immunogenicity of

critical commercial antigens. Contributed to 5-7 projects annually.

Staff Chemist, Combination Vaccine Development Group, Bioprocess R&D, (1997 to 2000)

Hired from temp-to-perm position to support clinical release and stability studies for pediatric combination

vaccine development.

4 recommendations available upon request

US Navy, Yeoman Second Class (E-5), Honorable Discharge at Military Experience

1986 - 1990 (4 years)

Commendations: Overseas Service Ribbon (2 awards), Meritorious Unit Commendation, Sea Service

Deployment Ribbon, Navy “E” Ribbon (2 awards), Letters of Commendation, Good Conduct Award

Education

Michigan State University

Bachelor of Science (BS), Medical Technology

Publications

Inhibition of Cathepsin K Increases Modeling-based Bone Formation, Improves Cortical Dimension and

Strength in Adult Ovariectomized Monkeys

Submitted JBMR 05 Nov 2013

Authors: Mary Belfast

Relationship between Tightness of Binding and Immunogenicity in an Aluminum-containing

Adjuvant-Adsorbed Hepatitis B Vaccine

Page2

Vaccine 27 (2009) 3175–3180 2009

Authors: Mary Belfast

Effect of the strength of adsorption of hepatitis B surface antigen to aluminum hydroxide adjuvant on the

immune response

Vaccine 27 (2009) 888 - 892

Authors: Mary Belfast

A Practical Approach to Optimization and Validation of a HPLC Assay for Analysis of

Polyribosyl-Ribitol Phosphate in Complex Combination Vaccines

J Chrom 832 (2006) 208-***-****

Authors: Mary Belfast

Optimization of Ultracentrifugation Conditions Used to Separate Unconjugated Polyribosyl-Ribitol

Phosphate (PRP) from Conjugated PRP in Hexavac, a Hexavalent Vaccine

Journal of BioProcess R&D, Vol. 3, Issue 1, August 2002

Authors: Mary Belfast

Etodolac Selectively Inhibits Human Prostaglandin G/H Synthase 2 (PGHS-2) Versus Human PGHS-1

European Journal of Pharmacology, Vol. 4, 1995, 107-111

Authors: Mary Belfast

Inhibition of Endotoxin-Induced Hypothermia and Serum TNF Alpha Levels in CD-1 Mice by Various

Pharmacological Agents

Agents Action, 39, Special Conference Issue (1993): C52-C54

Authors: Mary Belfast

A Comparison of Rapid Detection Tests

Advance for Medical Laboratory Professionals, Vol. 4, number 6, Feb. 10 1992, 6-7

Authors: Mary Belfast

ABSTRACT - The Effects of Anti-Inflammatory and Anti-Allergic Drugs on the Release of IL-1 Beta and

TNF Alpha in Human Whole Blood

FASEBJ., 7(3) A 160, 1993

Authors: Mary Belfast

PRESENTATION - A Strategy Employing Design of Experiment for Optimization and Validation of a

Stability Indicating Assay for Complex Combination Vaccines

SMi Group 3rd Annual Conference on Pharmaceutical Stability Testing, London, UK, 21-22, Sep 2005

Authors: Mary Belfast

PRESENTATION - A Strategy Employing Design of Experiment for Optimization and Validation of a

Stability Indicating Assay for Complex Combination Vaccines

Barnett Intl. Conference on Chromatography – Validation and Methods Development Conference, Philadelphia,

PA, 23-24, June 2005

Authors: Mary Belfast

Page3

PRESENTATION - A Practical Approach to Optimization and Validation of a Stability Indicating Assay

for Complex Combination Vaccines

Institution of Validation Technologies Conference on Stability Testing, Dublin, Ireland, Nov 29-Dec 2, 2004

Authors: Mary Belfast

PRESENTATION - A Practical Approach to Optimization and Validation of a Stability Indicating Assay

for Complex Combination Vaccines

Barnett Intl. Conference on Stability Testing, Philadelphia, PA, June 24 2004

Authors: Mary Belfast

PRESENTATION - Analytical Chromatographic Principles and Specific Examples of Applications

within Merck’s Research and Production Areas

Merck Biologics Licensing Department, August 2000

Authors: Mary Belfast

PRESENTATION - Optimization of Ultracentrifugation for Use in Separating Depolymerized

Polyribosyl-Ribitol Phosphate (PRP) in Hexavac™

Merck DOE Symposium, April 2000

Authors: Mary Belfast

PRESENTATION - Development of a Depolymerized Hib Assay for Use in Combination Vaccines

Bioprocess and Bioanalytical Department Annual Meeting, July 1999

Authors: Mary Belfast

PRESENTATION - Induced Desorption of Polyribosyl-Ribitol Phosphate (PRP) as a Function of

Phosphate and Carbonate

Merck DOE Symposium, March 1999

Authors: Mary Belfast

Skills & Expertise

Assay Development

Drug Development

Automation

Analytics

CRO

GLP

HPLC

Laboratory Robotics

Validation

In Vitro

Chromatography

Lifesciences

Biotechnology

Analytical Chemistry

Drug Design

Technology Transfer

Page4

Biomarkers

Vaccines

In Vivo

Immunology

Bioanalysis

Antibodies

Laboratory

Method Development

Immunoassays

Certifications

Medical Technologist (MT)

American Society of Clinical Pathologist

Page5

Mary Belfast

Assay Development, Validation and Transfer

*****@**********.***

4 people have recommended Mary

"Mary learns new areas, technology and methods quickly. I was particularly impressed when she picked up

the JMP programming language (JSL) so that she could automate statistical analyses of assay output. She is

also well versed in multifactor design of experiments (DOE) methodology and likewise has served as a

valuable intermediary between statisticians and scientists at our company."

Seth Clark, Biostatistician, Merck, worked with Mary at Merck and Company

"Mary is a dedicated, hard-working and motivated scientist. She is easy to work with and a great team

member. When handling any assignment, she makes sure she understands every detail and then gets it done

with perfection."

Richa Jayakar, Senior Scientist, Merck, worked with Mary at Merck and Company

"Mary has an extensive knowledge of analytical assays and GMP practices as applied to the vaccine method

development and validation. Great leadership skills. Excellent manager."

Irina Tumanova, Senior Scientist, Merck, reported to Mary at Merck and Company

"Mary is a very knowledgeable and experienced scientist. She has a broad understanding of bioanalytical

science starting from assay design and creation all the way through statistical validation. She has been a

trusted colleague and ‘go to’ person in our inter-departmental analytical collaborations."

Peter Szczerba, Sr. Research Biochemist, Merck, worked with Mary at Merck and Company

Contact Mary on LinkedIn

Page6

Contact this candidate