Manager Project
Resume:
Joseph A. Buettner
Lighthouse Point, FL 33064
abhwf1@r.postjobfree.com
Summary of Qualifications
Results oriented professional with over 25 years experience with proven
accomplishments in:
. QC laboratory Management
. Project Management in exploratory, development, manufacturing and
clinical biologicals
. Special Investigation Teams for OOS Team processes; BioAnalytics Lead
Scientist
. Coordinating contract and internal analytical/manufacturing resources
. Seven Patents for compounds and processes, diagnostics
. Biologicals Analytics: GMP/GLP development, qualification and
validation as per ICH/FDA requirements
. Group Leader of lab units and multidiscipline teams
Education
M.S. Microbiology, University of Wyoming 1981-1983; GPA=3.65/4.0; Gamma
Sigma Delta Scholastic Excellence Award. Thesis: Characterization of
resistance plasmids in clinical isolates of Serratia marcescens. Research
Advisor: Professor Phyllis D. Bear, Ph.D.
B.S. Zoology, University of Wyoming 1977-1981; Cellular and sub-cellular
biology; Research Advisor: Robert Jenkins, Ph.D.
Project Leadership Training
Summer 2003 Project Management Campbell University, Prof. Douglas Call,
Ph.D.
April 2001 Personal Leadership Effectiveness Continuous Learning Group,
Inc. Optimizing leadership style: insights to enhance positive behaviors
and limit detrimental behaviors.
June 2000 Project Leadership Strategic Management Group (SMG) Technical,
Behavioral and Change Management in Team Settings.
June 1996 Supervisory Development Blanchard Situational Leadership II,
Thomas-Kilman Conflict Mode Instrument, Principles for a Collaborative
Workplace.
Experience/Accomplishments
Independent Consultant - Analytics April
2010 to present.
. Provide guidance for Assay development, qualification and validation
of chemical, biochemical and biological assays for the Pharmaceutical
and Veterinary manufacturing industry.
. Help assess contract testing labs and results.
. Train staff in assay development and qualification to ICH
requirements.
Adjunct Professor - Microbiology Keiser University
June 2010 to present.
. Teach General Microbiology (lecture and lab) to undergraduate nursing
students.
Quality Control Manager, Goodwin Biotechnology, Inc. September
2009- January 2010
. Responsible for supervision of the Analytical Testing Laboratory and the
Microbiology Laboratory. Develop end Qualify assays to ICH Guidelines
(supervise Analytical Development Group). Create, review and revise SOPs
dealing with testing and sampling. Organize and schedule QC activities,
supervise QC Lab. Ensure competent performance of analytical and
microbiological personnel
. Represent QC in production meetings and other meetings as required.
Participate in audits.
. Responsible for the release of all testing reports.
. Coordinate testing to be performed in-house and by outside laboratories;
responsible for assuring proper documentation is received for all
incoming and outside testing.
. Investigate all out-of-control results.
. Write, review and/or edit test reports and enter data on release
specification sheets for products and stability control charts.
Senior Scientist/Group Leader, Commonwealth Biotechnologies, Inc.
November 2004-August 2009
. Principle Investigator, Forensic Toxin Identification: procurement,
storage, Chain of Custody, identification and quantitation assays (Tier
1, 2 and 3) of all protein and small molecule toxins for forensic
identification/quantitation of field samples. Oversee security of toxin
repository and controlled access laboratory for toxin analyses. Federal
Government/FBI/CDC security clearances (Intelligence Community and Dept
of Defense ISA/Secret). Responsible for creation and maintenance of
protein toxin fingerprints for identification of ricin, abrin, marine and
bacterial/fungal toxins by mass spectrometry methods (MALDI and LCMS).
. Direct supervision/mentor of 2 to 5 analytical biochemist technicians for
toxin identification; one PhD post-doc synthetic chemist and transient
temp technicians. Apportion manpower to sponsor projects. Maintain
technical training for each direct report. Responsible for direct
report(s)' work schedules to ensure timely results turn around.
. Customer Interaction for CRO including Mass Spectrometry services,
Organic Synthesis services, Proteomics.
. Implement, coordinate, report all aspects of BioAnalytics laboratory:
customize analyses by direct interaction with customer, accept samples
for analyses through Chain of Custody protocols, analyze by MALDI or LCMS
as per SOPs, report findings, bill hours. Coordinate resources in-house
for complex analytical procedures (biochemistry and immunology
departments).
. Responsible for all GMP/GLP Compliance (method development, SOP,
Qualification, Validation) for purity, quantitation and limit assays by
mass spectrometry. Responsible for IQ/OQ for all lab equipment.
Responsible for all direct reports' GMP/GLP training and compliance.
. Trouble-shoot everything (science, machines, personnel issues).
. Oversee sponsor timelines and milestones (both government and private
sector).
. Wrote/submitted government (HSARPA and DTRA Broad Agency Announcement)
and private sector project proposals.
Senior Research Scientist, Bayer Corporation.
May 1996 to October 2004
. Team Member: Development and Strategic Research Teams, represent
BioAnalytics on exploratory and development teams. Coordinate resources,
develop strategies and timelines, write technical documents in support of
Specified Biologicals, write sections of regulatory submissions.
. OOS Special Investigation Team(s): production trouble-shooting SWAT (IgG,
Albumin, Alpha-1-PI, rFVIII) processes and bioanalytics. Coordinate
contract analytical labs (GCP and GMP), write/review/approve internal
documentation, write/review approve sections of regulatory submissions.
. Control/Manage NCBC Grant in collaboration with NCSU Depts. of Chemistry
and Biochemistry for structural studies by FTIR, CD and Fluoresence.
. ICH Team Member: review for content/formulate new assay
strategy/write/review Validation Protocols.
. Analytical Biochemist: LCMS, HPLC and biochemistry assay development (new
assays research to development to validation); mentor technical
personnel.
. Diversity Group Leader, PELICAN Project Manager: Supervised research
group of up to 11 scientists that generated 15 patents and over 30
publications . Responsible for synthesis of compounds; on-resin assays
and cell-based assays; mimetic library development; managed diversity
group working concurrently on five projects. Identified and controlled
four academic research collaboration programs for technology development.
Responsible for financials for internal research group and external
contracts/collaborators.
Research Scientist, Miles Pharmaceutical (Bayer Corp.).
August 1993 to May 1996
. Manager of Peptide Synthesis facility.
. Supervised research group of 3 scientists.
Scientist Grade 1, Arris Pharmaceutical Inc., South San Francisco, CA.
July 1992 to July 1993
. Manager of Peptide Synthesis facility.
. Supervised research group of 2 scientists.
Senior Research Associate, Arris Pharmaceutical Inc. San Francisco, CA.
November 1990 to June 1992
. Responsible for creating the multiple peptide synthesis laboratory
(capacity of 150-250 peptides/week). Designed/fabricated an automated
multiple cleavage/precipitation/extraction/purification robot.
. Responsible for creation of analysis facility including amino acid
analyses, analytical microbore HPLC, mass spectrometry, and nitrogen
analysis. Also oversaw design/construction of facility.
Research Associate, Triton Biosciences, Alameda, CA.
September 1988 to September 1990
. Responsible for peptide synthesis, cleavage, purification and analyses
Scientist II, DNAX Research Institute, Palo Alto, CA.
Nov 1987 to Aug 1988
. Responsible for purification / biochemical characterization of
recombinant human and murine Interleukin 5.
Lab Manager/ Senior Lab Technician, Cortech, Inc., Denver, CO. September
1983 to October 1987
. Immuno-modification of immune responses via antigen presentation
involving peptide synthesis, coupling onto carriers and measuring effect
of cellular activation (mixed lymphocyte reactions).
A complete listing of 7 patents and 19 refereed journal references and
symposia talks provided in CV Addendum
Contact this candidate