Project Manager Years Experience
Resume:
Pier Hannah
Senior Microbiologist in Quality Control - Dendreon Corp
Mableton, GA
**********@*****.*** - 404-***-****
WORK EXPERIENCE
Senior Microbiologist in Quality Control
Dendreon Corp - May 2011 to Present
Perform microbiological testing on the innovative prostate cancer vaccine
Supervise laboratory technicians
Contractor
Georgia Perimeter College - Perimeter, Georgia, US - May 2010 to May 2012
Adjunct Professor
Teach Cell Biology and Genetics (teach molecular biology methods: FISH, PCR, etc.)
Teach microbiology
Consultant
ViaDiem Inc - April 2010 to April 2011
Scientific Expert (CMC requirements for FDA Submissions - IND and NDA)
Write scientific reports for FDA submissions
CMC Scientist. Dr. Hannah
Solvay Pharmaceuticals Inc - June 2007 to October 2009
works to ensure the quality of the influenza vaccine produced by
Solvay Pharmaceuticals, Inc.
Project lead: Seasonal and Pandemic Influenza Extraneous Agents Testing for FDA and
EMEA (European regulatory authorities).
Designed and implemented molecular (tissue culture) cytotoxicity studies (bio- comparability) influenza
vaccine
Designed in vivo bio-comparability (host immune response) studies to ensure
compliance with FDA CBER guidelines
(21 CFR) and the European Pharmacopeia 2.6.16 for manufacturing of biologicals and vaccines.
Interrupted data and generated reports used for FDA licensure.
Project Manager:
Developed product risk assessment for FDA
Developed molecular/immunological protocols to ensure compliance with federal/international
guidelines
Developed methods to determine residual DNA content in final vaccine bulk
Sterility testing of raw materials (i.e. trypsin and culture media)
Developed genetic methods to detect viral/bacterial sequences in final vaccine bulk
Wrote Basic Analytical Instructions for testing requirements and formulating the scaling up monvalent and
trivalent influenza vaccine bulk
Managed budgets $2 million for extraneous agents testing projects
Updated: 2/1/05
Senior Bio-containment Specialist. Dr. Hannah
Constella Group, LLC - February 2005 to June 2006
worked as a senior bio-containment specialist for Constella Group, LLC and hold clearances from CJIS and
CDC. This position was apart of the bio-terrorism rapid response preparedness plan. The capacity of my current
position ranges from ensuring that federal guidelines set forth by department of Homeland security and Health
and human services are met by U.S. lab working with select agents and toxins (microorganisms
that can be weaponized and the government regulates the possession, use, and transfer of such organisms)
to inspections of U.S. labs that conduct scientific work with potential biological
weapons (select agents and toxins) but also, assessing public health laboratories for the capacity to handle a
biological/chemical terrorist attack (state of California level A public health
labs). Planned and designed the technical and research approach for the NIH recombinant DNA
project.
Project lead: California Project trained public health workers (state of
California) on federal regulations (CFR 42) Ensured
compliance of CFR 42. Trained public health workers (state of California) on clinical testing and sterility testing
of select
agents and viral/bacterial sexually transmitted diseases (HIV,
Herpes, gonorrhea, etc.)
Project Manager: NIH recombinant DNA gene therapy project. To ensure
compliance to the NIH Guidelines for the use of recombinant DNA.
Ensured compliance to the use of human subjects during pre- clinical gene therapy trials. Ensure compliance
to the use of genetic
material in treatments with human subjects. Wrote the checklist
and/or computer algorhythm (tool use to score the compliance of each facility to the regulations). Planned
budget and personnel
requirements for project.
Post doctoral fellow
Emory University - 2004 to 2005
As a post doctoral fellow Dr. Hannah was responsible for the laboratory
budgets, protocols, and data analysis. In managing a lab, my responsibilities ranged from ensuring that the
forecasted budget was abided by and all supplies, salaries, and out-sourcing
cost were accounted and paid in a timely fashion. Formulating concentrations scale up formulations of anti-
inflammatory mediator drugs (COX-2 inhibitors and NOS inhibitors) Duties
also included ensuring that all staff and students worked together on projects and all data were
analyzed properly. Weekly meetings were the setting for project planning, open discussion of issues, and
conference planning.
Research Biologist
Centers for Disease Control and Prevention - May 2003 to November 2003
In this position, this work was conducted in collaboration with the EPA and the FBI to monitor air sample filters,
placed throughout the Atlanta metropolitan area, for positive identification of select agents (microorganisms
that have the potential to cause mass
destruction or to be used as biological weapons 42 CFR Part 73).
For this position, comprehension and compliance with the regulations set forth by
Homeland security, EPA, and the CDC were essential.
Updated: 2/1/05
Post doctoral fellow
Morehouse School of Medicine - 2002 to 2003
2002-2003)
Designed and implemented laboratory protocols and procedures for the detection of health disparities found
in several chemotherapy treatments for ovarian cancer found in
African-American women.
Post doctoral fellow, In this position, Dr. Hannah wrote two grants a NIH P50 supplemental
($250,000) and a Department of Defense ($150,000) minority award. She was responsible for the budget of
both grants and for the staff who worked on both projects. The NIH P50 project
involved defining the role of a mutant allele (CCR9) in African-American women and resistance to ovarian
chemotherapy treatment. There were two staff members Dr. Hannah had to manage and 20% of each staff
person's salary came from this grant. The DoD award was involved
determining whether the breast cancer genes BRCA1 and BRCA2 were in higher frequency in
African-American women. There was one student on this grant that I managed.
Research Assistant, As a research assistant
Morehouse School of Medicine - 1998 to 2003
1998-2003)
Designed and implemented laboratory protocols and procedures for the detection of HIV in the central nervous
system. This work was used in conjunction with other educational
requirements to publish my doctoral dissertation.
Research Assistant, As a research assistant, duties included writing all the protocols for my
experiments and for the lab staff as well as maintain the budget for the Qiagen Cabinet. The lab in which I
worked had a Qiagen Cabinet that house molecular biological products for purchase.
The monthly gross for the cabinet was $4,500. Dr. Hannah also wrote an NIH NRSA grant to supplement my
dissertation cost.
Designed adjuvant formulation for vaccine study for anti-HIV in the central nervous
system PhD dissertation
Research Assistant
Georgia State University - 1997 to 2002
5 year. Taught anatomy and physiology to nursing students.
Prepared and conducted lectures for the general biology and cell physiology classes.
Biology/Chemistry Tutor
Emporia State University - 1996 to 1997
1 year. Tutored university students in the areas of biology and chemistry.
Microbiology Research Assistant
Emporia State University - 1993 to 1997
4 year. Prepared identification media (agar plates,
slants, broth) for the biology classes at Emporia State University.
Microbiology Research Assistant
Emporia State University - 1990 to 1994
4 year. Used molecular and biochemical techniques to detect enteric bacteria from samples obtain from both
human and animal sources.
Sterility analysis of media and other raw materials.
Updated: 2/1/05
KEY QUALIFICATIONS
SKILLS/EXPERTISE
REGULATORY/COMPLIANCE AND LABORATORY SAFETY MONITOR (8 YEARS EXPERIENCE)
• CJIS and CDC security clearances
• ASME compliance to directional airflow (negative pressured labs) public health labs level
A
• ISO 17025 Compliance for laboratory testing of clinical samples labs conducting
biological/chemical weapons testing
• ISO 10993 Compliance for medical device for immune response; in vivo/in vitro
cytotoxicity Work to determined the bio-comparability (immune response) of both pandemic and seasonal
influenza vaccine products. Solvay Pharmaceuticals Inc.
• ISO 14000/14001 Compliance for Environmental Testing EPA Testing of air filters for biological and/or
chemical weapons
• ISO 17799 Compliance enforcement of information security 42 CFR Parts 72 and 73
• Worked to ensure compliance to the possession and used of Select Agents and Toxins as stated in the 42
Code of Federal Regulations. Ensure sterility testing compliance in level A
Labs Constella Health Sciences Health and Human Services Regulations and Food and
Drug Administration Regulations
• GMP and GLP: Work to ensure compliance to the NIH Guidelines Involving the Use of
Recombinant DNA. Sterility testing. Local and chronic immune response Constella Health
Sciences Solvay Pharmaceuticals Inc.
• Ensure compliance to all OSHA regulations for laboratory/occupational safety
• Conducted on-site safety inspections ASME Standards for directional airflow (Negative
pressured biological safety cabinets) of governmental and academic BSL-2 and BSL-3 labs
• Monitored Select Agent sites (labs that work with biological and/or chemical weapons)
Protocol Design ( 14 years experience)
• Designed immuno-histochemistry assays; included but NOT limited to;
monoclonal antibody usage, FACS Scan, and immuno-florescence
• Flow Cytometry
• Confocal Microscopy
• FISH
• Inflammatory mediator induction (bio-comparability)
• Inflammatory regulation (bio-comparability)
• Antibody titration response (bio-comparability)
• Real-time and Traditional Polymerase Chain Reaction (PCR)
• Transfection of gene products into an expression vector
Updated: 2/1/05
• Protein Kinetics - immunological reactions
• Drug formulations of anti-inflammatory mediators
• Central Nervous System (human, simian, mouse, and rat) immune response
assays
Molecular Biological Assay/Testing (14 years experience)
• Nucleic Acid hybridization (Northern and Southern Blotting)
• HPLC
• Chemical engineer of immune by-products
• Radio-isotope detection systems
• Flow Cytometry
• Antibody Titration Analysis (in vivo)
• Protein Kinetics
• Light and florescent microscopy
• Confocal Microscopy
• WAVE Analysis (a HPLC with the addition of sequencing)
• Infrared Microscopy
• Traditional and Real-time Polymerase Chain Reaction
• Radioisotope labeling
Microbiological Assay/Testing (15 years experience)
• Sera analysis for viral detection
• ELISA detection
• Bio-comparability analysis (sterility, humoral, cell mediate, and inflammation)
• Antibody Susceptibility
• Culture Isolation
• Bacteria fermentation
• Bioremediation
• Raw material testing
• Microscopy slide preparation
• Media preparation
Cell culture maintenance (8 years experience)
• Created an in vitro blood brain barrier (endothelial cells, astrocytes, and pericytes)
Updated: 2/1/05
• Maintained and propagated, primary human endothelial cells, human epithelial
cells, primary human ovarian epithelial cells, HUVEC's, macrophages,
neutropils, VERO, astrocytoma cells, and GHOS cells
• Isolation of cells from human tissues
Grant Writing/ Contract Proposal (6 years experience)
• P50 Minority Supplement NIH
• NRSA Pre-doctoral Award NIH
• SBIR/STTR NIH
• Department of Defense
• Contract Proposal
TEACHING EXPERIENCE
• Taught anatomy & physiology, microbiology, and cell biology
Updated: 2/1/05
EDUCATION
Ph.D. in molecular genetics and biochemistry
Georgia State University
2004
ADDITIONAL INFORMATION
KEY QUALIFICATIONS
SKILLS/EXPERTISE
REGULATORY/COMPLIANCE AND LABORATORY SAFETY MONITOR (8 YEARS EXPERIENCE)
• CJIS and CDC security clearances
• ASME compliance to directional airflow (negative pressured labs) public health labs level
A
• ISO 17025 Compliance for laboratory testing of clinical samples labs conducting
biological/chemical weapons testing
• ISO 10993 Compliance for medical device for immune response; in vivo/in vitro
cytotoxicity Work to determined the bio-comparability (immune response) of both
pandemic and seasonal influenza vaccine products. Solvay Pharmaceuticals Inc.
• ISO 14000/14001 Compliance for Environmental Testing EPA Testing of air filters for
biological and/or chemical weapons
• ISO 17799 Compliance enforcement of information security 42 CFR Parts 72 and 73
• Worked to ensure compliance to the possession and used of Select Agents and Toxins as
stated in the 42 Code of Federal Regulations. Ensure sterility testing compliance in level A
Labs Constella Health Sciences Health and Human Services Regulations and Food and
Drug Administration Regulations
• GMP and GLP: Work to ensure compliance to the NIH Guidelines Involving the Use of
Recombinant DNA. Sterility testing. Local and chronic immune response Constella Health
Sciences Solvay Pharmaceuticals Inc.
• Ensure compliance to all OSHA regulations for laboratory/occupational safety
• Conducted on-site safety inspections ASME Standards for directional airflow (Negative
pressured biological safety cabinets) of governmental and academic BSL-2 and BSL-3 labs
• Monitored Select Agent sites (labs that work with biological and/or chemical weapons)
Protocol Design ( 14 years experience)
• Designed immuno-histochemistry assays; included but NOT limited to;
monoclonal antibody usage, FACS Scan, and immuno-florescence
• Flow Cytometry
• Confocal Microscopy
• FISH
• Inflammatory mediator induction (bio-comparability)
• Inflammatory regulation (bio-comparability)
• Antibody titration response (bio-comparability)
• Real-time and Traditional Polymerase Chain Reaction (PCR)
• Transfection of gene products into an expression vector
Updated: 2/1/05
• Protein Kinetics - immunological reactions
• Drug formulations of anti-inflammatory mediators
• Central Nervous System (human, simian, mouse, and rat) immune response
assays
Molecular Biological Assay/Testing (14 years experience)
• Nucleic Acid hybridization (Northern and Southern Blotting)
• HPLC
• Chemical engineer of immune by-products
• Radio-isotope detection systems
• Flow Cytometry
• Antibody Titration Analysis (in vivo)
• Protein Kinetics
• Light and florescent microscopy
• Confocal Microscopy
• WAVE Analysis (a HPLC with the addition of sequencing)
• Infrared Microscopy
• Traditional and Real-time Polymerase Chain Reaction
• Radioisotope labeling
Microbiological Assay/Testing (15 years experience)
• Sera analysis for viral detection
• ELISA detection
• Bio-comparability analysis (sterility, humoral, cell mediate, and inflammation)
• Antibody Susceptibility
• Culture Isolation
• Bacteria fermentation
• Bioremediation
• Raw material testing
• Microscopy slide preparation
• Media preparation
Cell culture maintenance (8 years experience)
• Created an in vitro blood brain barrier (endothelial cells, astrocytes, and
pericytes)
Updated: 2/1/05
• Maintained and propagated, primary human endothelial cells, human epithelial
cells, primary human ovarian epithelial cells, HUVEC's, macrophages,
neutropils, VERO, astrocytoma cells, and GHOS cells
• Isolation of cells from human tissues
Grant Writing/ Contract Proposal (6 years experience)
• P50 Minority Supplement NIH
• NRSA Pre-doctoral Award NIH
• SBIR/STTR NIH
• Department of Defense
• Contract Proposal
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