Barbara Blue has over 25 years of experience in analytical biochemistry research, regulatory compliance management, instrument validation, instructional design, project management, and personnel management. She has extensive experience in analytical method development, assay validation, technology transfer, writing SOPs, and applying regulatory guidance. She is skilled in developing training programs, managing learning management systems, and migrating records to electronic databases.

1. Barbara A. Blue
409 S. 10th Street
North Wales, PA 19454
(H) 215-661-8522
barbblue2002@comcast.net
SUMMARY
Over 25 years experience working in the areas of analytical biochemistry research, regulatory
compliance management, instrument validation, instructional designer, project management and
personnel management.
- Extensive Bio-analytical laboratory experience with immunology, proteins, nucleic acids,
carbohydrates, and lipids
- Analytical method development, Assay Validation and Technology Transfer
- Wrote departmental SOP’s for Equipment Maintenance, Training and Equipment Validation
- Experience applying regulatory guidance in various laboratory situations
- Prepare and deliver regulatory compliance training (traditional, e-Learning and WebX)
- Develop web-based instruction curriculum for departmental SOPs, regulatory and policy training
- System Course Administrator for Learning Management System (LMS)
- Experience with pharmaceutical document management; SOPs, Analytical Methods, PM Plans,
Validation Documents, Change Control, RIARs and MCMs
- Develop and implement a departmental master validation strategy & prepare SDLC validation
template plans for analytical instruments
- Ability to work independently and collaboratively on multidisciplinary and multifunctional teams
- Manage migration of hardcopy training records into electronic database within LMS
- Manage project for departmental website design and management
- Exceptional leadership skills; managing collaborative team projects and direct personnel supervision
- Successful with strategic planning and determining resource requirements
- Excellent at problem solving skills, employing various alternative means of resolution
EDUCATION
LaSalle University, Philadelphia, PA
BA Degree in Biology; LaSalle University, 1983.
Masters Degree Teaching Program (1993 - 1995)
Teaching Certification - Secondary Biology, 1994
Lehigh University, Lehigh, PA
Masters Degree Molecular Biology (June 4, 2000)
George Washington University, Washington D.C.,
Masters Level – Educational Leadership & Technology
- Developing WWW Materials for Education

2. OTHER SKILLS, QUALITIES, ACCOMPLISHMENTS
Personnel Development Skills; Supervisory Experience, Instructional Experience, Development of
Cooperative Team Management, Secondary Teaching Certification in Biology in PA & NJ, and
Elementary Teaching Certification in NJ
Computer Skills;
Authoring Tools - Trainersoft, MS Powerpoint, Articulate Presenter, Articulate Quizmaster,
Photoshop, Paintshop Pro, Captivate, Gameshow Pro, Dreamweaver, Flash, Visio, Flow Chart, WebX
Desktop applications – MS Word, MS Excel, MS Access, MS Publisher, MS Project, Crystal Reports,
CAD, LIMS, Databases, Statistical Analysis
Operating systems - UNIX, Oracle, VAX, MacIntosh and DOS & Windows
Hardware - Component Installation, IQ, OQ, PQ, instrument decommission, radiological survey
Regulatory Compliance Experience; GMP, GCP & GLP
Quantitative Biochemical Analysis; ELISA, Spectrophotometer Analysis, RIA, TLC, HPLC,
Radioactive Isotope Handling and Analysis
Molecular Biology Techniques; Northern Blot Analysis, Southern Blot Analysis, Western Blot
Analysis, RFLP Analysis, Mobility Shift Assay, Digital Image Analysis and Quantification, and
Photographic Documentation
Cytological Techniques; Tissue Culture, Cytogenetics, Cellular Separation, Immuno-Histological
Techniques, Histological Techniques for Light and Electron Microscopy
Medical Diagnostic Procedures; Blood Banking and Histo-compatibility, Urinalysis, Microbiology,
Hematology, Venipuncture, Serology, Small Animal Surgery
PROFESSIONAL EXPERIENCE
Deviation Management Investigator; Merck & Co.; MMD; West Point, PA (May – July 2009)
Document and investigate deviations to the manufacturing process, quality standards and testing of
biological products. Investigation includes determination of Root Cause, Product Impact and deviation
trending.
Clinical Validation Specialist; Catalent Pharma Solutions; Philadelphia, PA (January 2008 –
November 2008)
Responsible for the development and implementation of procedures for the validation of equipment
and systems. Develop and implement Master Validation Plan. Ensure equipment compliance with
regulatory and internal quality system requirements as well as current industry practice.
Maintain equipment calibration schedules and database. Develop equipment and maintenance SOPs
and PM plans. Evaluate incoming clinical products for cleaning validations and prepare appropriate
documentation.

3. GMP Training Specialist; AstraZeneca (Contract Scientist); Wilmington; DE (January 2007 –
June 2007)
Responsible for the development, coordination and management of activities associated with the
generation and administration of both global and local change management business processes for the
US business.
- Serve as USBC Change Control & Documentation administrator within Technical Document
Management System (TDMS) electronic document management system. Manage TDMS User
distribution lists.
- Responsible to create, track and close out RIARs and MCM’s for global manufacturing changes.
- Create Change Requests (CR) within TDMS from incoming global MCM’s proposals
- Establish and maintain US business process for MCM.
- Responsible for the GMP mandated Annual Product Review (APR) business process for outside
contractors and global manufacturing sites. Resolve discrepancies for each APR.
Quality Assurance Biochemist; GSK (contract scientist); Upper Merion-East; PA (July 2006 –
January 2007)
- Data mine clinical supply batch documentation to assess validity and evaluate compliance risk
- Review clinical production data to identify potential risks prior to regulatory filings
- Compile analytical validation documentation and technology transfer documentation in preparation
for Pre-Approval Inspection (PAI)
- Evaluate data within LIMS, notebooks and databases for apparent errors
- Tabulate and report finding throughout the Quality Organizations
Merck & Co. ;Merck Research Laboratories; West Point, PA (August 1994 – August 2005)
Research Chemist; (September 2001 – Aug. 2005)
Provide regulatory compliance support for analytical laboratories testing clinical samples from vaccine
clinical trials.
Instructional Development
- System Course Administrator for Learning Management System (LMS)
- Develop web-based instruction for departmental SOP’s using different instructional development
applications.
- Implement assessment strategy to document learner’s comprehension and evaluate the quality of
instruction.
- Implement automated tracking mechanism to document training attendance and migrate attendance
information into TIS database.
- Implement different instructional strategies as appropriate of the content objectives.
Training Records Management
- Manage project for migration of historical training records into corporate database for training
records
- Implement a filing system for departmental training required records
-Developed batch upload tool, process data for enrollment entry of department training records and
verified accuracy of the data migration.
- Write departmental Training SOP
- Supervise employee hired to manually enter individual training records for the department.
Maintenance Compliance
- Manage project to bring department’s equipment maintenance programs into state of current
compliance.
- Write departmental PM and Unscheduled Maintenance SOP
- Develop an equipment inventory for the department
- Update Merck’s maintenance databases

4. - Supervise staff engineers on projects to develop and revise PM plans and schedules as necessary
Instrument Validation (21CFR Part 11 Compliance)
- Prepare a departmental master validation strategy with CVQA and WGMPQA.
- Develop and implement departmental SLC validation template set for analytical instruments
- Write departmental SOP for operational policies to comply with cGMP regulations.
- Train laboratory staff in the preparation and implementation of equipment validation documents.
Staff Chemist; (August 1994 – September 2001)
- Provided analytical support for characterization and clinical development of vaccine products
- Develop and validate analytical methods to quantify and characterize proteins, lipids, carbohydrates,
and ELISAs.
- Determine HIV neutralizing antibody titers on human serum samples.
- HPSEC, disc centrifugation, and agarose gel electrophoresis analysis of HPV vaccine product to
characterize particle size distribution and aggregation stability.
- Protein quantification using BCA analysis.
- Lipid characterization of vaccine product intermediates by TLC and HPLC using evaporative light
scattering detector.
- Technical resource for REES environmental monitoring system
- Investigations into O-Acetate instability of polysaccharides using EIA immunoassays.
- Immunoassay development and optimization to quantify antigenicity, potency and completeness of
adsorption in polysaccharide vaccine products.
- Instructional and technical support for colleagues with computer hardware and software.
- Maintain stability protocols of vaccine clinical supply in GMP compliant laboratory.
- Documentation of compliance with GMP regulations and data analysis.
Teaching Certification Internship – (February - April 1994)
Northeast High School – Philadelphia, PA
- Curriculum taught: Biology and Anatomy & Physiology at the 9th, 10th, 11th and 12th grade level
- Prepared and executed lesson plans, prepared assessments, and implemented
- Effectively utilized classroom management strategies as needed
- Developed computer-designed instructional materials
Pulmonary Research Associate: Albert Einstein Medical Center (Aug. 1992 – Dec. 1992)
- Total lipid characterization and analysis
- Cytological techniques, Tissue Culture, ELISA
Oncology Research Scientist: Janssen Research Foundation (March 1991 - January 1992)
- Tissue culture, Drug screening, H3 Thymidine incorporation, ELISA
- Total RNA extraction, m- RNA purification, Northern Blot Analysis
- Western Blot analysis and Mobility Shift Assay for SP-1
- Optimization of Chemiluminescent Detection system with digital CCD camera system
Molecular Biologist (Contract): DuPont Company ( August 1989 - March 1991)
- Automation of Southern Blot Analysis; optimization electrophoresis and hybridization techniques
and reagents.
- Analytical development using chemiluminescent detection systems and novel immuno-detection
schemes.
- Software development interfacing Macintosh PC's to CCD camera hardware
- Quantitative analysis using luminometer, flurometer, spectrophotometer, X-ray film and CCD
camera.
- Instructed new members on project standard operating procedures with some supervisory
responsibilities.

5. - Member of the Team Leadership Committee - charged with promoting a positive team spirit amongst
project members.
Research Technician: Albert Einstein Medical Center (July 1984 - August 1989)
Dept. of Obstetrics and Gynecology/Oncology (October 1988 - August 1989)
- Assay development and writing SOPs.
- Instructed Ob/Gyn surgical residents in standard laboratory operating procedures.
- Tissue culture (primary cultures from tumors).
- Cytogenetic techniques, Biochemistry, RIA & ELISA.
- Molecular Biology ; DNA extraction, Southern Blot Analysis.
- Techniques in immunohistochemistry; sterile surgery and tumor generation in athymic mice.
Dept. of Gastroenterology (July 1984 - October 1988)
- Managed G.I. research lab; daily operations, budget, statistical evaluation and interpretation of data.
- Supervisory experience and instruction of personnel.
- Small animal surgery, Maintained small animals on Total Parenteral Nutrition
- Biochemical & histological radio-labeled analytical techniques
- Cellular separation and identification, ELISA
ACADEMIC AND PROFESSIONAL HONORS
Merck Award of Excellence; February 13, 1998 and December 1998
PUBLICATIONS
Abstracts
1. (1985). "Regulation of Jejunal Amino Acid Absorption of Metabolic and Luminal Factors."
Gastroenterology 88: 1325.
2. (1986). "Effects of Long and Medium Chain Triglycerides on Intestinal Adaptation."
Gastroenterology 90: 1686.
3. (1987). "Effects of Long and Medium Chain Triglycerides on Ileal Adaptation." Gastroenterology
92: 1584.
4. Blue, B. A. (1996). Validation of Molecular Size, Polydispersity, & Concentration Determination
for Bacterial Polysaccharides using High Performance Size Exclusion Chromatography. Eastern
Analytical Symposium.
Papers
1. R.K. Kobos1, B.A. Blue., C.W. Robertson, and L.A Kielhorn (1995). "Enhancement of Enzyme-
Activated 1,2-Dioxetane Chemiluminescence in Membrane- Based Assays." Analytical
Biochemistry(224): 128-133.
Masters Thesis
1. Blue, B. A. (2000). "p53 Induced Apoptosis; Understanding Its Mechanism As a Therapeutic Means
for Disease Intervention". Biology. Bethlehem, Lehigh University: 80.