Biologics Consulting Group
Description
Address: 1555 King St Suite 300, Alexandria, VA 22314 Hours: Closed ⋅ Opens 9AM Mon Friday9AM–5PMSaturdayClosedSundayClosedMonday9AM–5PMTuesday9AM–5PMWednesday9AM–5PMThursday9AM–5PMSuggest an edit Unable to add this file. Please check that it is a valid photo. Phone: (703) 739-5695: : : : : Website: Place name: : Category: Website: http://www.biologicsconsulting.com/ Category: Business management consultant Suggest an editUnable to add this file. Please check that it is a valid photo. Unable to add this file. Please check that it is a valid photo. Add a photoThanks for sharing!Your photo will be posted publicly on Google.Contribute MoreDoneUpload public photos of Biologics Consulting Posting publicly on the Web Write a review Reviews 2 Google reviews
Biologics Consulting Group List of Employees There's an exhaustive list of past and present employees! Get comprehensive information on the number of employees at Biologics Consulting Group. You can filter them based on skills, years of employment, job, education, department, and prior employment.
Biologics Consulting Group Salaries. You can even request information on how much does Biologics Consulting Group pay if you want to. Learn about salaries, pros and cons of working for Biologics Consulting Group directly from the past employees.
Find People by Employers You can rekindle an old relationship, reconnect with a long-lost friend, former boss, business acquaintance who might be useful in your new line of work. With our employee database, the possibilities are endless. All you have to do is type in a couple of keywords and we'll bring you the exact information you wanted!
38 Biologics Consulting Group employees in database. Find out everything there's to know about Biologics Consulting Group employees. We offer you a great deal of unbiased information from the internal database, personal records, and many other details that might be of interest to you.
Biologics Consulting Group Employees
Employee
Years
Job
Industry
Rajesh K. Gupta Rajesh K. Gupta's Biologics Consulting Group Experience April 2004 - August 2006
Job Visionary Scientific & Compliance Consultant
Industry Pharmaceuticals
Experience
Biologics Quality & Regulatory Consultants, LLC May 2013 - Present
FDA September 2006 - February 2013
Biologics Consulting Group April 2004 - August 2006
Wyeth Research 2001 - April 2004
Wyeth-Lederle Vaccines & Pediatrics September 1997 - 2001
Chiron Corporation September 1996 - August 1997
Massachusetts Public Health Biologics Laboratories September 1991 - July 1996
National Institutes of Health July 1989 - August 1991
NII - National Institute of Immunology March 1989 - March 1991
Central Research Institute, Japanese Encephalitis Vaccine Division September 1984 - March 1989
Skills
FDA, Vaccines, Regulatory Affairs, GLP, GMP, IND, Validation, Assay Development, Biopharmaceuticals, Technology Transfer, Infectious Diseases, Microbiology, Analytical Methods..., Clinical Trials, Sop, Biotechnology, Analytical Chemistry, Drug Development, Change Control, Combination Vaccines, Adjuvants and Delivery..., Biologics Quality, Protein Chemistry, Biologics Compliance, ELISA, V&V, Quality System, Pharmaceutical Industry, Laboratory, Quality Control, Cell Culture, Cell, PCR, Biologics Compliance..., Molecular Biology, In Vitro, Formulation, Chemistry, Protein Purification, Lifesciences, LIMS, Monoclonal Antibodies, SOP, Life Sciences
Education
Himachal Pradesh University 1985 — 1988
Doctor of Philosophy (Ph.D.), Microbiology and Immunology
Himachal Pradesh University 1983 — 1985
Master of Philosophy (M.Phil.), Microbiology and Immunology
Himachal Pradesh University 1980 — 1982
Master of Science (M.Sc.), Microbiology and Immunology, Gold Medal
Himachal Pradesh University 1978 — 1980
Bachelor of Science (B.Sc.), Microbiology and Immunology, Gold Medal
Government College, Hoshiarpur, Punjab, Panjab University 1974 — 1977
Bachelor of Science (B.Sc.), Chemistry, Botany, Zoology, First Division
Biologics Quality & Regulatory Consultants, LLC May 2013 - Present
FDA September 2006 - February 2013
Biologics Consulting Group April 2004 - August 2006
Wyeth Research 2001 - April 2004
Wyeth-Lederle Vaccines & Pediatrics September 1997 - 2001
Chiron Corporation September 1996 - August 1997
Massachusetts Public Health Biologics Laboratories September 1991 - July 1996
National Institutes of Health July 1989 - August 1991
NII - National Institute of Immunology March 1989 - March 1991
Central Research Institute, Japanese Encephalitis Vaccine Division September 1984 - March 1989
Skills
FDA, Vaccines, Regulatory Affairs, GLP, GMP, IND, Validation, Assay Development, Biopharmaceuticals, Technology Transfer, Infectious Diseases, Microbiology, Analytical Methods..., Clinical Trials, Sop, Biotechnology, Analytical Chemistry, Drug Development, Change Control, Combination Vaccines, Adjuvants and Delivery..., Biologics Quality, Protein Chemistry, Biologics Compliance, ELISA, V&V, Quality System, Pharmaceutical Industry, Laboratory, Quality Control, Cell Culture, Cell, PCR, Biologics Compliance..., Molecular Biology, In Vitro, Formulation, Chemistry, Protein Purification, Lifesciences, LIMS, Monoclonal Antibodies, SOP, Life Sciences
Education
Himachal Pradesh University 1985 — 1988
Doctor of Philosophy (Ph.D.), Microbiology and Immunology
Himachal Pradesh University 1983 — 1985
Master of Philosophy (M.Phil.), Microbiology and Immunology
Himachal Pradesh University 1980 — 1982
Master of Science (M.Sc.), Microbiology and Immunology, Gold Medal
Himachal Pradesh University 1978 — 1980
Bachelor of Science (B.Sc.), Microbiology and Immunology, Gold Medal
Government College, Hoshiarpur, Punjab, Panjab University 1974 — 1977
Bachelor of Science (B.Sc.), Chemistry, Botany, Zoology, First Division
Ruth Ellis Ruth Ellis's Biologics Consulting Group Experience February 2015 - Present
Job Senior Consultant at Biologics Consulting Group
Industry Biotechnology
Experience
Biologics Consulting Group February 2015 - Present
Aeras May 2012 - February 2015
National Institutes of Health 2005 - June 2012
Armed Forces Research Institute of Medical Science 2003 - 2005
Skills
GMP, Clinical Study Design, Clinical Research, Vaccines, Clinical Development, Clinical Trials, Immunology, Bioinformatics, Pharmacodynamics, Validation, Epidemiology, Medicine, GCP, Infectious Diseases, Protocol, Life Sciences, FDA, Biotechnology, Assay Development
Education
University of Colorado Anschutz Medical Campus
MPH
University of Illinois College of Medicine
MD
Biologics Consulting Group February 2015 - Present
Aeras May 2012 - February 2015
National Institutes of Health 2005 - June 2012
Armed Forces Research Institute of Medical Science 2003 - 2005
Skills
GMP, Clinical Study Design, Clinical Research, Vaccines, Clinical Development, Clinical Trials, Immunology, Bioinformatics, Pharmacodynamics, Validation, Epidemiology, Medicine, GCP, Infectious Diseases, Protocol, Life Sciences, FDA, Biotechnology, Assay Development
Education
University of Colorado Anschutz Medical Campus
MPH
University of Illinois College of Medicine
MD
Annie Zurbay Annie Zurbay's Biologics Consulting Group Experience December 2004 - Present
Job Senior Consultant and Manager of Medical Writing at Biologics Consulting Group
Industry Pharmaceuticals
Experience
Biologics Consulting Group December 2004 - Present
OSI Pharmaceuticals 2002 - 2004
Skills
Clinical Development, Biopharmaceuticals, Clinical Trials, Regulatory Affairs, Oncology, Biotechnology, Sop, Pharmaceutical Industry, Lifesciences, Drug Discovery, FDA, Regulatory Submissions, Regulatory Requirements, CRO, GCP, IND, Drug Development, Technology Transfer, Vaccines, GLP, Life Sciences
Education
University of Colorado Anschutz Medical Campus 1999 — 2000
MSN (Family Nurse Practitioner Program)
University of Colorado Health Sciences Center 1995 — 1999
ND (Doctor of Nursing)
Biologics Consulting Group December 2004 - Present
OSI Pharmaceuticals 2002 - 2004
Skills
Clinical Development, Biopharmaceuticals, Clinical Trials, Regulatory Affairs, Oncology, Biotechnology, Sop, Pharmaceutical Industry, Lifesciences, Drug Discovery, FDA, Regulatory Submissions, Regulatory Requirements, CRO, GCP, IND, Drug Development, Technology Transfer, Vaccines, GLP, Life Sciences
Education
University of Colorado Anschutz Medical Campus 1999 — 2000
MSN (Family Nurse Practitioner Program)
University of Colorado Health Sciences Center 1995 — 1999
ND (Doctor of Nursing)
Vince Narbut Vince Narbut's Biologics Consulting Group Experience February 2011 - Present
Job Senior Consultant at Biologics Consulting Group
Industry Biotechnology
Experience
Biologics Consulting Group February 2011 - Present
Biogen Idec 2007 - January 2011
Biogen Idec 2005 - 2007
Biogen Idec 2001 - 2005
Biogen Idec 2000 - 2001
Biogen Idec March 1996 - February 2000
Biogen 1985 - 1996
Skills
GMP, Validation, FDA, Technology Transfer, Biopharmaceuticals, Biotechnology, Quality System, 21 CFR Part 11, Change Control, Pharmaceutical Industry, Quality Assurance, Cross-functional Team..., Quality Management, GAMP, Process Simulation, Process Engineering, Purification, Medical Devices, Cell Culture, Lifesciences, Quality Auditing, Aseptic Processing, Fermentation, Drug Discovery, R&D, LIMS, CAPA, GLP, V&V, People Skills, GxP, Life Sciences
Education
Babson College - Franklin W. Olin Graduate School of Business
MBA
Cornell University
BA, Biochemistry
Biologics Consulting Group February 2011 - Present
Biogen Idec 2007 - January 2011
Biogen Idec 2005 - 2007
Biogen Idec 2001 - 2005
Biogen Idec 2000 - 2001
Biogen Idec March 1996 - February 2000
Biogen 1985 - 1996
Skills
GMP, Validation, FDA, Technology Transfer, Biopharmaceuticals, Biotechnology, Quality System, 21 CFR Part 11, Change Control, Pharmaceutical Industry, Quality Assurance, Cross-functional Team..., Quality Management, GAMP, Process Simulation, Process Engineering, Purification, Medical Devices, Cell Culture, Lifesciences, Quality Auditing, Aseptic Processing, Fermentation, Drug Discovery, R&D, LIMS, CAPA, GLP, V&V, People Skills, GxP, Life Sciences
Education
Babson College - Franklin W. Olin Graduate School of Business
MBA
Cornell University
BA, Biochemistry
Craig Halverson Craig Halverson's Biologics Consulting Group Experience May 2010 - April 2012
Job
Industry Biotechnology
Experience
Halverson Biopharmaceutical Consulting LLC May 2014 - Present
Coherus BioSciences May 2014 - April 2015
Coherus BioSciences May 2012 - April 2014
Biologics Consulting Group May 2010 - April 2012
Halverson Biopharmaceutical Consulting LLC November 2009 - May 2010
SciClone Pharmaceuticals January 2008 - October 2009
ZymoGenetics 2004 - 2007
Introgen Therapeutics, Inc. 2004 - 2004
CancerVax Corporation 2001 - 2004
Gen-Probe Incorporated 1998 - 2001
Skills
Biopharmaceuticals, Oncology, FDA, Regulatory Affairs, GMP, Infectious Diseases, Regulatory Submissions, Vaccines, Medical Devices, IND, Cell, Protein Chemistry, Quality System, Monoclonal Antibodies, Therapeutic Areas, Commercialization, Biotechnology, Quality Assurance, Biologics, Pharmaceutical Industry, EU Scientific Advice, Biosimilars, CTA, ANDA, NDA, National Scientific..., Central Scientific..., BPD Type 1-4 Meetings, GxP, Drug Development, Technology Transfer, Clinical Development, Pharmaceutics, Sop, Clinical Trials, Validation, GLP, SOP, 21 CFR Part 11
Education
University of Southern California 1977 — 1980
MS, Experimental Pathology
Halverson Biopharmaceutical Consulting LLC May 2014 - Present
Coherus BioSciences May 2014 - April 2015
Coherus BioSciences May 2012 - April 2014
Biologics Consulting Group May 2010 - April 2012
Halverson Biopharmaceutical Consulting LLC November 2009 - May 2010
SciClone Pharmaceuticals January 2008 - October 2009
ZymoGenetics 2004 - 2007
Introgen Therapeutics, Inc. 2004 - 2004
CancerVax Corporation 2001 - 2004
Gen-Probe Incorporated 1998 - 2001
Skills
Biopharmaceuticals, Oncology, FDA, Regulatory Affairs, GMP, Infectious Diseases, Regulatory Submissions, Vaccines, Medical Devices, IND, Cell, Protein Chemistry, Quality System, Monoclonal Antibodies, Therapeutic Areas, Commercialization, Biotechnology, Quality Assurance, Biologics, Pharmaceutical Industry, EU Scientific Advice, Biosimilars, CTA, ANDA, NDA, National Scientific..., Central Scientific..., BPD Type 1-4 Meetings, GxP, Drug Development, Technology Transfer, Clinical Development, Pharmaceutics, Sop, Clinical Trials, Validation, GLP, SOP, 21 CFR Part 11
Education
University of Southern California 1977 — 1980
MS, Experimental Pathology
Stuart Portnoy, MD Stuart Portnoy, MD's Biologics Consulting Group Experience August 2007 - Present
Job Senior Consultant, Medical Devices at Biologics Consulting Group / Professional Email = sportnoy at bcgusa dot com
Industry Medical Devices
Experience
Biologics Consulting Group August 2007 - Present
PharmaNet July 2002 - July 2007
FDA - Medical Devices 1994 - 2002
Skills
Medical Devices, FDA, Clinical Trials, Regulatory Submissions, Regulatory Analysis, Regulatory Requirements, Cardiac Rhythm..., Cardiac..., Cardiac Cath, Heart Failure, Heart Disease, Drug Delivery, Biologics
Education
George Washington University Medical School 1986 — 1991
MD, Internal Medicine
University of Pennsylvania 1987 — 1988
MS, Bioengineering
Tufts University 1981 — 1985
BS, Chemical Engineering
Biologics Consulting Group August 2007 - Present
PharmaNet July 2002 - July 2007
FDA - Medical Devices 1994 - 2002
Skills
Medical Devices, FDA, Clinical Trials, Regulatory Submissions, Regulatory Analysis, Regulatory Requirements, Cardiac Rhythm..., Cardiac..., Cardiac Cath, Heart Failure, Heart Disease, Drug Delivery, Biologics
Education
George Washington University Medical School 1986 — 1991
MD, Internal Medicine
University of Pennsylvania 1987 — 1988
MS, Bioengineering
Tufts University 1981 — 1985
BS, Chemical Engineering
Lew Barker Lew Barker's Biologics Consulting Group Experience 2015 - Present
Job Senior Clinical Consultant at Biologics Consulting Group
Industry Biotechnology
Experience
Biologics Consulting Group, Inc. January 2015 - Present
Biologics Consulting Group 2015 - Present
Skills
Clinical Trials, Clinical Development, Lifesciences, Vaccines, Infectious Diseases, Regulatory Submissions, Clinical Research, Immunology, Research, Biotechnology, Cell, GCP, Drug Development
Education
The Johns Hopkins University Schools of Medicine and Public Health 1959 — 1991
MD and MPH, Infectious diseases and preventive medicine
Princeton University 1951 — 1955
Bachelor of Arts (B.A.), History
Biologics Consulting Group, Inc. January 2015 - Present
Biologics Consulting Group 2015 - Present
Skills
Clinical Trials, Clinical Development, Lifesciences, Vaccines, Infectious Diseases, Regulatory Submissions, Clinical Research, Immunology, Research, Biotechnology, Cell, GCP, Drug Development
Education
The Johns Hopkins University Schools of Medicine and Public Health 1959 — 1991
MD and MPH, Infectious diseases and preventive medicine
Princeton University 1951 — 1955
Bachelor of Arts (B.A.), History
Orest Hurko, M.D. Orest Hurko, M.D.'s Biologics Consulting Group Experience June 2010 - December 2012
Job Medical Director, EMD Serono
Industry Pharmaceuticals
Experience
Tufts University January 2015 - Present
EMD Serono June 2013 - Present
ADNI Data and Publications Committee 2007 - Present
Clinical Translational Medicine January 2013 - June 2013
Biologics Consulting Group June 2010 - December 2012
University of Dundee 2008 - September 2011
Pfizer Pharmaceuticals October 2009 - June 2010
Wyeth Pharmaceuticals 2003 - October 2009
Translational Medicine Research Collaboration July 2006 - May 2009
GlaxoSmithKline January 2002 - January 2003
Skills
Clinical Trials, Neuroscience, Research, Medicine, Lifesciences, Clinical Development, Pharmaceutical Industry, Clinical Research, Oncology, Biotechnology, Translational Medicine, Drug Discovery, Biomarkers, Medical Devices, FDA, Healthcare, Pharmacology, Infectious Diseases, Product Development, Regulatory Affairs, In Vitro, Cell, Drug Development, Biochemistry, Genetics, Assay Development, Protein Chemistry, GCP, Molecular Genetics, Pediatric Neurology, Neurology, Biopharmaceuticals, Molecular Biology, Medical Affairs, Immunology, Vaccines, DNA, Cancer, Medical Writing, Psychiatry, Clinical Study Design, Laboratory, CRO, In Vivo, Regulatory Submissions, Biomarker Discovery, Translational Research, Toxicology, Genomics, Technology Transfer
Education
Harvard Medical School 1969 — 1974
M.D., Medicine
Massachusetts Institute of Technology 1971 — 1972
Nutrition and Food Science
Harvard University 1966 — 1969
B.A., Biochemical Sciences
St Xavier
Tufts University January 2015 - Present
EMD Serono June 2013 - Present
ADNI Data and Publications Committee 2007 - Present
Clinical Translational Medicine January 2013 - June 2013
Biologics Consulting Group June 2010 - December 2012
University of Dundee 2008 - September 2011
Pfizer Pharmaceuticals October 2009 - June 2010
Wyeth Pharmaceuticals 2003 - October 2009
Translational Medicine Research Collaboration July 2006 - May 2009
GlaxoSmithKline January 2002 - January 2003
Skills
Clinical Trials, Neuroscience, Research, Medicine, Lifesciences, Clinical Development, Pharmaceutical Industry, Clinical Research, Oncology, Biotechnology, Translational Medicine, Drug Discovery, Biomarkers, Medical Devices, FDA, Healthcare, Pharmacology, Infectious Diseases, Product Development, Regulatory Affairs, In Vitro, Cell, Drug Development, Biochemistry, Genetics, Assay Development, Protein Chemistry, GCP, Molecular Genetics, Pediatric Neurology, Neurology, Biopharmaceuticals, Molecular Biology, Medical Affairs, Immunology, Vaccines, DNA, Cancer, Medical Writing, Psychiatry, Clinical Study Design, Laboratory, CRO, In Vivo, Regulatory Submissions, Biomarker Discovery, Translational Research, Toxicology, Genomics, Technology Transfer
Education
Harvard Medical School 1969 — 1974
M.D., Medicine
Massachusetts Institute of Technology 1971 — 1972
Nutrition and Food Science
Harvard University 1966 — 1969
B.A., Biochemical Sciences
St Xavier
Timothy Schofield's Biologics Consulting Group Experience 2008 - 2009
Job Senior Fellow at MedImmune
Industry Pharmaceuticals
Experience
MedImmune November 2012 - Present
USP June 2010 - Present
Arlenda Inc. November 2011 - November 2012
GlaxoSmithKline Biologicals July 2009 - November 2011
United States Pharmacopeia 2006 - 2010
Biologics Consulting Group 2008 - 2009
Merck May 2005 - December 2008
Merck July 1999 - April 2005
Merck October 1993 - June 1999
Merck December 1987 - September 1993
Skills
Validation, Statistics, Regulatory Affairs, Vaccines, Stability, Specifications, Bioassay, Lifesciences, Pharmaceutical Industry, Biotechnology, Design of Experiments, Clinical Development, Pharmaceutics, Analytical Chemistry, Biologics, Biopharmaceuticals, Formulation, Clinical Trials, Assay Development, Technology Transfer, GMP, Quality Control, FDA
Education
University of Pennsylvania - The Wharton School 1974 — 1976
MA, Statistics & Operations Research
Lafayette College 1969 — 1973
BS, Mathematics
MedImmune November 2012 - Present
USP June 2010 - Present
Arlenda Inc. November 2011 - November 2012
GlaxoSmithKline Biologicals July 2009 - November 2011
United States Pharmacopeia 2006 - 2010
Biologics Consulting Group 2008 - 2009
Merck May 2005 - December 2008
Merck July 1999 - April 2005
Merck October 1993 - June 1999
Merck December 1987 - September 1993
Skills
Validation, Statistics, Regulatory Affairs, Vaccines, Stability, Specifications, Bioassay, Lifesciences, Pharmaceutical Industry, Biotechnology, Design of Experiments, Clinical Development, Pharmaceutics, Analytical Chemistry, Biologics, Biopharmaceuticals, Formulation, Clinical Trials, Assay Development, Technology Transfer, GMP, Quality Control, FDA
Education
University of Pennsylvania - The Wharton School 1974 — 1976
MA, Statistics & Operations Research
Lafayette College 1969 — 1973
BS, Mathematics
Louise Johnson Louise Johnson's Biologics Consulting Group Experience March 2007 - January 2011
Job Executive Director, Regulatory Affairs at Nektar Therapeutics
Industry Pharmaceuticals
Experience
Nektar Therapeutics June 2011 - Present
Neuraltus Pharmaceuticals February 2011 - July 2011
Biologics Consulting Group March 2007 - January 2011
Renovis April 2004 - January 2007
Pain Therapeutics September 2003 - April 2004
Elan April 1997 - May 2002
Elan Pharmaceuticals 1996 - 2002
Athena Neurosciences October 1995 - March 1997
Cygnus August 1994 - October 1995
DuPont Merck Pharmaceutical Co. 1991 - 1994
Skills
GLP, Regulatory Affairs, Biotechnology, Clinical Trials, FDA, GMP
Education
Villanova University 1985 — 1992
M.S., Applied Statistics
University of California, Santa Barbara 1976 — 1978
B.A., Physiological Psychology
Harvey Mudd College 1973 — 1976
none, Individual Program of Studies
Nektar Therapeutics June 2011 - Present
Neuraltus Pharmaceuticals February 2011 - July 2011
Biologics Consulting Group March 2007 - January 2011
Renovis April 2004 - January 2007
Pain Therapeutics September 2003 - April 2004
Elan April 1997 - May 2002
Elan Pharmaceuticals 1996 - 2002
Athena Neurosciences October 1995 - March 1997
Cygnus August 1994 - October 1995
DuPont Merck Pharmaceutical Co. 1991 - 1994
Skills
GLP, Regulatory Affairs, Biotechnology, Clinical Trials, FDA, GMP
Education
Villanova University 1985 — 1992
M.S., Applied Statistics
University of California, Santa Barbara 1976 — 1978
B.A., Physiological Psychology
Harvey Mudd College 1973 — 1976
none, Individual Program of Studies
Larry Winberry Larry Winberry's Biologics Consulting Group Experience September 2001 - June 2015
Job President @ LKW Expert BioConsulting
Industry Biotechnology
Experience
LKW Expert BioConsulting June 2015 - Present
Biologics Consulting Group September 2001 - June 2015
BioPort Corporation, Lansing, MI. May 1999 - September 2001
Baxter Hyland-Immuno, Rochester, MI October 1993 - May 1999
Lederle-Praxis Biologics 1990 - 1992
Mass Biologics Laboratory 1986 - 1989
Michigan Public Health Biologic Labs 1983 - 1985
Case Western Reserve University 1979 - 1981
Skills
Biopharmaceuticals, GMP, Validation, FDA, Technology Transfer, Biotechnology, Change Control, Regulatory Submissions, Regulatory Affairs, Vaccines, Lifesciences, V&V, Quality System, GxP, Regulatory Requirements, CAPA, Pharmaceutics, Quality Auditing, Drug Discovery, LIMS, Oncology, Quality Assurance, Sop, IND, Aseptic Processing, Medical Devices, R&D, Process Simulation, Quality Control, Pharmaceutical Industry, GLP, Drug Development, ISO 13485, Clinical Development, Laboratory, Biochemistry, GAMP, Clinical Trials, Cleaning Validation, Commercialization, 21 CFR Part 11, GCP, Immunology, CRO, Infectious Diseases, Microbiology, Analytical Chemistry, Computer System..., Molecular Biology, Assay Development
Education
University of California, Riverside 1968 — 1976
B.S and Ph.D., Biochemistry
Chaffey High School 1965 — 1968
HIgh School
LKW Expert BioConsulting June 2015 - Present
Biologics Consulting Group September 2001 - June 2015
BioPort Corporation, Lansing, MI. May 1999 - September 2001
Baxter Hyland-Immuno, Rochester, MI October 1993 - May 1999
Lederle-Praxis Biologics 1990 - 1992
Mass Biologics Laboratory 1986 - 1989
Michigan Public Health Biologic Labs 1983 - 1985
Case Western Reserve University 1979 - 1981
Skills
Biopharmaceuticals, GMP, Validation, FDA, Technology Transfer, Biotechnology, Change Control, Regulatory Submissions, Regulatory Affairs, Vaccines, Lifesciences, V&V, Quality System, GxP, Regulatory Requirements, CAPA, Pharmaceutics, Quality Auditing, Drug Discovery, LIMS, Oncology, Quality Assurance, Sop, IND, Aseptic Processing, Medical Devices, R&D, Process Simulation, Quality Control, Pharmaceutical Industry, GLP, Drug Development, ISO 13485, Clinical Development, Laboratory, Biochemistry, GAMP, Clinical Trials, Cleaning Validation, Commercialization, 21 CFR Part 11, GCP, Immunology, CRO, Infectious Diseases, Microbiology, Analytical Chemistry, Computer System..., Molecular Biology, Assay Development
Education
University of California, Riverside 1968 — 1976
B.S and Ph.D., Biochemistry
Chaffey High School 1965 — 1968
HIgh School
Kelly Reich Kelly Reich's Biologics Consulting Group Experience July 2001 - Present
Job Regulatory Project Manager at Biologics Consulting Group, Inc.
Industry Biotechnology
Experience
Biologics Consulting Group July 2001 - Present
Skills
Biotechnology, Licensing, Pharmaceutical Industry, Microsoft Excel, Project Management, Microsoft Office, FDA, IND
Education
The Johns Hopkins University 2004 — 2007
Master of Science (MS), Biotechnology
James Madison University 1997 — 2001
Bachelor of Science (B.S.), Biotechnology
Biologics Consulting Group July 2001 - Present
Skills
Biotechnology, Licensing, Pharmaceutical Industry, Microsoft Excel, Project Management, Microsoft Office, FDA, IND
Education
The Johns Hopkins University 2004 — 2007
Master of Science (MS), Biotechnology
James Madison University 1997 — 2001
Bachelor of Science (B.S.), Biotechnology
Vijay Jethwa, MBA PhD's Biologics Consulting Group Experience July 2013 - Present
Job Senior Consultant at Biologics Consulting Group
Industry Biotechnology
Experience
Biologics Consulting Group July 2013 - Present
Merck May 2012 - June 2013
Biogen Idec August 2010 - February 2012
Biogen Idec July 2008 - August 2010
Biogen April 2000 - July 2008
Diagnostic Products Corporation 1998 - 2000
UNC Hospitals 1992 - 1995
Skills
cGMP, Biopharmaceuticals, Regulatory Submissions, Molecular Biology, QC, Antibodies, Biotechnology, Pharmaceuticals, Technology Transfer, Clinical Development, Validation, Cell Based Assays, GMP, Regulatory Affairs, Life Sciences, Clinical Trials, Chromatography, Purification, SOP, Cell Culture, Biochemistry, FDA, Protein Chemistry, IND, Immunology, Change Control, GLP, Western Blotting, LIMS, ELISA, Process Validation, Cell Biology, Medical Devices, HPLC, SDS-PAGE, R&D, Process Development, Protein Purification, 21 CFR Part 11, Clinical Research, Cross-functional Team..., Microbiology, Drug Discovery, Quality Assurance, GCP, Monoclonal Antibodies, Cell, Drug Development, Assay Development, Pharmaceutical Industry
Education
University of North Carolina at Chapel Hill 2010 — 2012
MBA, Leadership & Strategy
University of North Carolina at Chapel Hill 1995 — 1998
PhD, Cellular and Molecular Pathology
University of North Carolina at Chapel Hill 1990 — 1992
BS, Medical Technology
University of North Carolina at Chapel Hill 1983 — 1987
BS, Biology
Biologics Consulting Group July 2013 - Present
Merck May 2012 - June 2013
Biogen Idec August 2010 - February 2012
Biogen Idec July 2008 - August 2010
Biogen April 2000 - July 2008
Diagnostic Products Corporation 1998 - 2000
UNC Hospitals 1992 - 1995
Skills
cGMP, Biopharmaceuticals, Regulatory Submissions, Molecular Biology, QC, Antibodies, Biotechnology, Pharmaceuticals, Technology Transfer, Clinical Development, Validation, Cell Based Assays, GMP, Regulatory Affairs, Life Sciences, Clinical Trials, Chromatography, Purification, SOP, Cell Culture, Biochemistry, FDA, Protein Chemistry, IND, Immunology, Change Control, GLP, Western Blotting, LIMS, ELISA, Process Validation, Cell Biology, Medical Devices, HPLC, SDS-PAGE, R&D, Process Development, Protein Purification, 21 CFR Part 11, Clinical Research, Cross-functional Team..., Microbiology, Drug Discovery, Quality Assurance, GCP, Monoclonal Antibodies, Cell, Drug Development, Assay Development, Pharmaceutical Industry
Education
University of North Carolina at Chapel Hill 2010 — 2012
MBA, Leadership & Strategy
University of North Carolina at Chapel Hill 1995 — 1998
PhD, Cellular and Molecular Pathology
University of North Carolina at Chapel Hill 1990 — 1992
BS, Medical Technology
University of North Carolina at Chapel Hill 1983 — 1987
BS, Biology
Nadine M. Ritter, Ph.D. Nadine M. Ritter, Ph.D.'s Biologics Consulting Group Experience August 2005 - December 2013
Job President and Analytical Advisor, Global Biotech Experts LLC
Industry Biotechnology
Experience
Global Biotech Experts, LLC January 2014 - Present
CaSSS 2012 - Present
Scientific Advisory Board UMBC Biotechnology Graduate Program 2010 - Present
CaSSS July 2003 - Present
PTI-UK 2002 - Present
IBC Life Sciences 2001 - Present
BioProcess International 2001 - Present
Biologics Consulting Group August 2005 - December 2013
American Red Cross Plasma Derivatives 2002 - 2005
BioReliance 1998 - 2002
Skills
GMP, Validation, Biopharmaceuticals, Biotechnology, FDA, Pharmaceutical Industry, Technology Transfer, Lifesciences, Quality Auditing, Medical Devices, Regulatory Requirements, GLP, Quality System, Chromatography, Protein Chemistry, Biochemistry, Hardware Diagnostics, R&D, Microbiology, Clinical Development, Commercialization, CMC development, Analytical Chemistry, Quality Control, IND, Quality Assurance, Drug Discovery, CRO, Drug Development, Laboratory, Infectious Diseases, Clinical Trials, Regulatory Affairs, Immunology, Life Sciences
Education
The University of Texas Health Science Center at Houston 1988 — 1992
Post-doc, Cell Biology of Biomineralization
Rice University 1984 — 1988
MS-Ph.D., Cell and Molecular Biology
University of Houston-Clear Lake 1978 — 1984
BS, Cell and Molecular Biology
San Jacinto College 1976 — 1978
Associate of Science (A.S.), Biology
Global Biotech Experts, LLC January 2014 - Present
CaSSS 2012 - Present
Scientific Advisory Board UMBC Biotechnology Graduate Program 2010 - Present
CaSSS July 2003 - Present
PTI-UK 2002 - Present
IBC Life Sciences 2001 - Present
BioProcess International 2001 - Present
Biologics Consulting Group August 2005 - December 2013
American Red Cross Plasma Derivatives 2002 - 2005
BioReliance 1998 - 2002
Skills
GMP, Validation, Biopharmaceuticals, Biotechnology, FDA, Pharmaceutical Industry, Technology Transfer, Lifesciences, Quality Auditing, Medical Devices, Regulatory Requirements, GLP, Quality System, Chromatography, Protein Chemistry, Biochemistry, Hardware Diagnostics, R&D, Microbiology, Clinical Development, Commercialization, CMC development, Analytical Chemistry, Quality Control, IND, Quality Assurance, Drug Discovery, CRO, Drug Development, Laboratory, Infectious Diseases, Clinical Trials, Regulatory Affairs, Immunology, Life Sciences
Education
The University of Texas Health Science Center at Houston 1988 — 1992
Post-doc, Cell Biology of Biomineralization
Rice University 1984 — 1988
MS-Ph.D., Cell and Molecular Biology
University of Houston-Clear Lake 1978 — 1984
BS, Cell and Molecular Biology
San Jacinto College 1976 — 1978
Associate of Science (A.S.), Biology
Megan Greenwood's Biologics Consulting Group Experience June 2014 - Present
Job Administrative Assistant at Biologics Consulting Group
Industry Hospital & Health Care
Experience
Biologics Consulting Group June 2014 - Present
Best Practices, Inc. January 2014 - May 2014
George Mason University August 2011 - May 2014
Linden Resources, Inc. January 2010 - July 2011
Massage Green July 2009 - November 2009
Veterans of Foreign Wars February 2008 - May 2008
St. Mary's Regional Medical Center April 2006 - December 2007
USAF August 2002 - August 2006
USAF August 2002 - March 2006
TexSan Heart Hospital July 2005 - December 2005
Skills
Customer Service, ICU, Healthcare, Hospitals, Medicine, EKG, Medical Records, Treatment, Vital Signs, Mental Health, Software Documentation, Microsoft Word, Microsoft Office, Microsoft Excel, Medical Terminology, Data Entry, Patient Safety, Military Training, Military Experience, Policy, Teaching, EMR, Healthcare Management, BLS, AED, Management, Patient Education, Leadership, Critical Thinking, HIPAA, EHR, Telephone Skills, ACLS, Appointment Scheduling, Inpatient, Patient Advocacy, EMT, First Aid, Outlook, PowerPoint, Time Management, Clerical Skills, Organization, Friendly Personality
Education
George Mason University 2011 — 2014
Bachelor of Applied Science (BASc), Health/Health Care Administration/Management
Eastern Michigan University 2008 — 2009
N/A, Art (Graphic Design), Nursing, General Studies
Northern Oklahoma College 2006 — 2007
N/A, Nursing, General Studies
Biologics Consulting Group June 2014 - Present
Best Practices, Inc. January 2014 - May 2014
George Mason University August 2011 - May 2014
Linden Resources, Inc. January 2010 - July 2011
Massage Green July 2009 - November 2009
Veterans of Foreign Wars February 2008 - May 2008
St. Mary's Regional Medical Center April 2006 - December 2007
USAF August 2002 - August 2006
USAF August 2002 - March 2006
TexSan Heart Hospital July 2005 - December 2005
Skills
Customer Service, ICU, Healthcare, Hospitals, Medicine, EKG, Medical Records, Treatment, Vital Signs, Mental Health, Software Documentation, Microsoft Word, Microsoft Office, Microsoft Excel, Medical Terminology, Data Entry, Patient Safety, Military Training, Military Experience, Policy, Teaching, EMR, Healthcare Management, BLS, AED, Management, Patient Education, Leadership, Critical Thinking, HIPAA, EHR, Telephone Skills, ACLS, Appointment Scheduling, Inpatient, Patient Advocacy, EMT, First Aid, Outlook, PowerPoint, Time Management, Clerical Skills, Organization, Friendly Personality
Education
George Mason University 2011 — 2014
Bachelor of Applied Science (BASc), Health/Health Care Administration/Management
Eastern Michigan University 2008 — 2009
N/A, Art (Graphic Design), Nursing, General Studies
Northern Oklahoma College 2006 — 2007
N/A, Nursing, General Studies
Brenna Powers's Biologics Consulting Group Experience June 2012 - August 2012
Job Digital 2D Artist & Animator
Industry Animation
Experience
Floyd County Productions September 2015 - Present
Biologics Consulting Group June 2012 - August 2012
Advanced Solutions International July 2011 - July 2011
Grow Career Coaching May 2011 - July 2011
West Potomac High School January 2011 - January 2011
Skills
Toon Boom, After Effects, Animation, Art, Logo Design, Photoshop, Illustrator, Flash Animation, Character Animation, Computer Animation, Traditional Animation, Dreamweaver, Storyboarding, Storyboard Pro, Wacom Tablet
Education
Savannah College of Art and Design 2011 — 2015
Bachelor of Fine Arts (BFA), Animation, Senior
Floyd County Productions September 2015 - Present
Biologics Consulting Group June 2012 - August 2012
Advanced Solutions International July 2011 - July 2011
Grow Career Coaching May 2011 - July 2011
West Potomac High School January 2011 - January 2011
Skills
Toon Boom, After Effects, Animation, Art, Logo Design, Photoshop, Illustrator, Flash Animation, Character Animation, Computer Animation, Traditional Animation, Dreamweaver, Storyboarding, Storyboard Pro, Wacom Tablet
Education
Savannah College of Art and Design 2011 — 2015
Bachelor of Fine Arts (BFA), Animation, Senior
Peter Patriarca's Biologics Consulting Group Experience May 2005 - Present
Job Senior Consultant at Biologics Consulting Group
Industry Biotechnology
Experience
Biologics Consulting Group May 2005 - Present
MedImmune, Inc. August 2001 - April 2005
FDA January 1994 - August 2001
Centers for Disease Control and Prevention July 1980 - December 1993
Skills
Regulatory Affairs, Vaccines, Clinical Development, Virology, Influenza, Pediatrics, Antiviral Agents, Pharmacovigilance, Clinical Research, Regulatory Submissions, Infectious Diseases, Public Health, Biologics, FDA, Antiviral, Epidemiology, Lifesciences, Medicine, Monoclonal Antibodies, Life Sciences, Biotechnology
Education
Tulane University School of Medicine
M.D., Medicine
University of Colorado Affiliated Hospitals
Internship and Residency in Pediatrics, Board Certification
University of Notre Dame
B.S., Pre-professional Studies
Biologics Consulting Group May 2005 - Present
MedImmune, Inc. August 2001 - April 2005
FDA January 1994 - August 2001
Centers for Disease Control and Prevention July 1980 - December 1993
Skills
Regulatory Affairs, Vaccines, Clinical Development, Virology, Influenza, Pediatrics, Antiviral Agents, Pharmacovigilance, Clinical Research, Regulatory Submissions, Infectious Diseases, Public Health, Biologics, FDA, Antiviral, Epidemiology, Lifesciences, Medicine, Monoclonal Antibodies, Life Sciences, Biotechnology
Education
Tulane University School of Medicine
M.D., Medicine
University of Colorado Affiliated Hospitals
Internship and Residency in Pediatrics, Board Certification
University of Notre Dame
B.S., Pre-professional Studies
Liana Harvath Liana Harvath's Biologics Consulting Group Experience March 2007 - March 2008
Job Independent Biotechnology Professional
Industry Biotechnology
Experience
Liana Harvath, PhD, LLC 2008 - Present
National Heart, Lung, and Blood Institute, National Institutes of Health July 2008 - October 2011
Biologics Consulting Group March 2007 - March 2008
National Heart, Lung, and Blood Institute, National Institutes of Health January 2002 - January 2007
National Heart, Lung, and Blood Institute, National Institutes of Health July 2000 - January 2002
Center for Biologics Evaluation and Research, Food and Drug Administration November 1999 - July 2000
Center for Biologics Evaluation and Research, FDA June 1992 - November 1999
Center for Biologics Evaluation and Research, FDA June 1983 - June 1992
National Cancer Institute, National Institutes of Health September 1979 - June 1983
University of Illinois Medical Center July 1978 - September 1979
Skills
Biotechnology, Immunology, FDA, Biopharmaceuticals, Cell Culture, Stem Cells, Biochemistry, Cell Biology, Clinical Trials, Cell, Lifesciences, Research, Regulatory Affairs, Blood Bank, Hematology, Microbiology, Molecular Biology, Toxicology, Flow Cytometry, Clinical Research, Cancer, Medical Devices, Infectious Diseases, Laboratory, Clinical Development, Drug Development, ELISA, Drug Discovery, Vaccines, Genetics, Life Sciences
Education
University of Illinois College of Medicine 1973 — 1976
Ph.D., Pathology
Michigan State University 1971 — 1973
B.S., Microbiology
Liana Harvath, PhD, LLC 2008 - Present
National Heart, Lung, and Blood Institute, National Institutes of Health July 2008 - October 2011
Biologics Consulting Group March 2007 - March 2008
National Heart, Lung, and Blood Institute, National Institutes of Health January 2002 - January 2007
National Heart, Lung, and Blood Institute, National Institutes of Health July 2000 - January 2002
Center for Biologics Evaluation and Research, Food and Drug Administration November 1999 - July 2000
Center for Biologics Evaluation and Research, FDA June 1992 - November 1999
Center for Biologics Evaluation and Research, FDA June 1983 - June 1992
National Cancer Institute, National Institutes of Health September 1979 - June 1983
University of Illinois Medical Center July 1978 - September 1979
Skills
Biotechnology, Immunology, FDA, Biopharmaceuticals, Cell Culture, Stem Cells, Biochemistry, Cell Biology, Clinical Trials, Cell, Lifesciences, Research, Regulatory Affairs, Blood Bank, Hematology, Microbiology, Molecular Biology, Toxicology, Flow Cytometry, Clinical Research, Cancer, Medical Devices, Infectious Diseases, Laboratory, Clinical Development, Drug Development, ELISA, Drug Discovery, Vaccines, Genetics, Life Sciences
Education
University of Illinois College of Medicine 1973 — 1976
Ph.D., Pathology
Michigan State University 1971 — 1973
B.S., Microbiology
Miriam Provost Miriam Provost's Biologics Consulting Group Experience September 2008 - Present
Job Senior Consultant, Medical Devices at Biologics Consulting Group
Industry Medical Devices
Experience
Biologics Consulting Group September 2008 - Present
FDA July 2005 - September 2007
FDA December 2001 - March 2005
FDA May 2000 - December 2001
FDA September 1994 - June 2000
Skills
FDA, Medical Devices, Biotechnology, Biopharmaceuticals, GxP, Clinical Trials, Quality System, Regulatory Submissions, Clinical Development, Regulatory Affairs, Regulatory Requirements, CAPA, Technology Transfer, Validation, V&V, Change Control, GMP, 21 CFR Part 11
Education
University of Pennsylvania 1984 — 1989
Doctor of Philosophy (Ph.D.), Chemical Engineering
University of Dayton 1979 — 1983
Bachelor of Science (B.S.), Chemical Engineering
Biologics Consulting Group September 2008 - Present
FDA July 2005 - September 2007
FDA December 2001 - March 2005
FDA May 2000 - December 2001
FDA September 1994 - June 2000
Skills
FDA, Medical Devices, Biotechnology, Biopharmaceuticals, GxP, Clinical Trials, Quality System, Regulatory Submissions, Clinical Development, Regulatory Affairs, Regulatory Requirements, CAPA, Technology Transfer, Validation, V&V, Change Control, GMP, 21 CFR Part 11
Education
University of Pennsylvania 1984 — 1989
Doctor of Philosophy (Ph.D.), Chemical Engineering
University of Dayton 1979 — 1983
Bachelor of Science (B.S.), Chemical Engineering
Ronald Salerno's Biologics Consulting Group Experience February 2008 - Present
Job Senior Consultant at Biologics Consulting Group
Industry Biotechnology
Experience
Biologics Consulting Group February 2008 - Present
Wyeth Research July 2006 - February 2008
Wyeth Research June 2001 - June 2006
Merck & Co., Inc February 1997 - June 2001
Merck January 1996 - February 1997
Merck Research Labs 1973 - 1996
Merck & Co., Inc June 1994 - December 1995
Merck & Co., Inc January 1990 - December 1993
Skills
Life Sciences, Pharmacogenomics, Clinical Development, Regulatory Affairs, Vaccines, Molecular Biology, Oncology, FDA, Lifesciences, Clinical Trials, CAPA, Biomarkers, Biotechnology, Regulatory Submissions, Pharmaceutical Industry, Clinical Research, Protein Chemistry, Medical Devices, Therapeutic Areas, In Vitro, Biologics, Monoclonal Antibodies, Biopharmaceuticals, Drug Development, Protocol, Personalized Medicine
Education
University of Maryland College Park 1966 — 1971
M.S., Ph.D., Zoology
Villanova University 1964 — 1966
M.S., Biology
Saint Vincent College 1960 — 1964
B.A., Biology
Biologics Consulting Group February 2008 - Present
Wyeth Research July 2006 - February 2008
Wyeth Research June 2001 - June 2006
Merck & Co., Inc February 1997 - June 2001
Merck January 1996 - February 1997
Merck Research Labs 1973 - 1996
Merck & Co., Inc June 1994 - December 1995
Merck & Co., Inc January 1990 - December 1993
Skills
Life Sciences, Pharmacogenomics, Clinical Development, Regulatory Affairs, Vaccines, Molecular Biology, Oncology, FDA, Lifesciences, Clinical Trials, CAPA, Biomarkers, Biotechnology, Regulatory Submissions, Pharmaceutical Industry, Clinical Research, Protein Chemistry, Medical Devices, Therapeutic Areas, In Vitro, Biologics, Monoclonal Antibodies, Biopharmaceuticals, Drug Development, Protocol, Personalized Medicine
Education
University of Maryland College Park 1966 — 1971
M.S., Ph.D., Zoology
Villanova University 1964 — 1966
M.S., Biology
Saint Vincent College 1960 — 1964
B.A., Biology
Angela Blackwell Angela Blackwell's Biologics Consulting Group Experience October 2007 - July 2012
Job Senior Consultant at Blackwell Device Consulting
Industry Medical Devices
Experience
Blackwell Device Consulting July 2012 - Present
Biologics Consulting Group October 2007 - July 2012
Food and Drug Administration CDRH March 1994 - October 2007
Skills
FDA, Biotechnology, Lifesciences, Medical Devices, Regulatory Affairs, Clinical Trials, Technology Transfer, R&D, Biomedical Engineering, Regulatory Submissions, Pharmaceutical Industry, Biopharmaceuticals, Validation, Clinical Development, Clinical Research, Quality System, Commercialization, Product Development, V&V, 21 CFR Part 11
Education
University of Alabama at Birmingham 1989 — 1992
M.S., Biomedical Engineering
Tulane University 1985 — 1989
B.S., Biomedical Engineering
Decatur High School 1981 — 1985
Blackwell Device Consulting July 2012 - Present
Biologics Consulting Group October 2007 - July 2012
Food and Drug Administration CDRH March 1994 - October 2007
Skills
FDA, Biotechnology, Lifesciences, Medical Devices, Regulatory Affairs, Clinical Trials, Technology Transfer, R&D, Biomedical Engineering, Regulatory Submissions, Pharmaceutical Industry, Biopharmaceuticals, Validation, Clinical Development, Clinical Research, Quality System, Commercialization, Product Development, V&V, 21 CFR Part 11
Education
University of Alabama at Birmingham 1989 — 1992
M.S., Biomedical Engineering
Tulane University 1985 — 1989
B.S., Biomedical Engineering
Decatur High School 1981 — 1985
James Kenimer James Kenimer's Biologics Consulting Group Experience 1993 - 2011
Job Consultant Emeritus & Chairman
Industry Pharmaceuticals
Experience
Biologics Consulting Group, Inc 2011 - Present
US Coast Guard Auxiliary 2012 - Present
Biologics Consulting Group 1993 - 2011
FDA 1980 - 1993
Education
Emory University 1962 — 1972
PhD, Biochemistry
Biologics Consulting Group, Inc 2011 - Present
US Coast Guard Auxiliary 2012 - Present
Biologics Consulting Group 1993 - 2011
FDA 1980 - 1993
Education
Emory University 1962 — 1972
PhD, Biochemistry
Steven M Walker's Biologics Consulting Group Experience January 2015 - Present
Job
Industry Biotechnology
Experience
Biologics Consulting Group January 2015 - Present
MedImmune October 2013 - November 2014
MedImmune July 2012 - February 2014
MedImmune July 2011 - July 2012
Genentech June 2008 - August 2011
Genentech December 2004 - June 2008
Genentech June 2003 - December 2004
Skills
Biotechnology, Oncology, Pharmaceutical Sales, Rheumatology, Managed Care, Pharmaceutical Industry, Pulmonology, Immunology, Dermatology, Biopharmaceuticals, Neurology, Cardiology, Allergy, Infectious Diseases, Leadership, Vaccines, Cross-functional Team..., Sales Management, Therapeutic Areas, Medical Devices, Diabetes, Clinical Research, Biologics, Product Launch, Commercialization
Education
University of Pittsburgh
B.S.
University of Pittsburgh - Graduate School of Public Health
Master of Health Administration
University of Pittsburgh - Joseph M. Katz Graduate School of Business
MBA
Biologics Consulting Group January 2015 - Present
MedImmune October 2013 - November 2014
MedImmune July 2012 - February 2014
MedImmune July 2011 - July 2012
Genentech June 2008 - August 2011
Genentech December 2004 - June 2008
Genentech June 2003 - December 2004
Skills
Biotechnology, Oncology, Pharmaceutical Sales, Rheumatology, Managed Care, Pharmaceutical Industry, Pulmonology, Immunology, Dermatology, Biopharmaceuticals, Neurology, Cardiology, Allergy, Infectious Diseases, Leadership, Vaccines, Cross-functional Team..., Sales Management, Therapeutic Areas, Medical Devices, Diabetes, Clinical Research, Biologics, Product Launch, Commercialization
Education
University of Pittsburgh
B.S.
University of Pittsburgh - Graduate School of Public Health
Master of Health Administration
University of Pittsburgh - Joseph M. Katz Graduate School of Business
MBA
Chris Vessely's Biologics Consulting Group Experience February 2015 - Present
Job
Industry Biotechnology
Experience
Biologics Consulting Group February 2015 - Present
KBI Biopharma May 2014 - January 2015
Merck April 2009 - May 2014
Insmed Therapeutic Proteins July 2005 - March 2009
University of Colorado Health Sciences 2001 - 2006
FeRx incorporated 1995 - 2002
Colorado school of mines 1991 - 1996
Skills
Analytical method..., CMC writing, formulation development, biophysical..., Biotechnology, Protein Chemistry, Biopharmaceuticals, Formulation, Regulatory Submissions, Project Management, Laboratory, Product Development, Leadership, GMP, Technology Transfer, HPLC, Drug Delivery
Education
University of Colorado Health Sciences Center 2001 — 2006
Doctor of Philosophy (PhD), Pharmaceutical Sciences, under John Carpenter
Colorado School of Mines 1991 — 1996
B.S., Chemical Engineering
Biologics Consulting Group February 2015 - Present
KBI Biopharma May 2014 - January 2015
Merck April 2009 - May 2014
Insmed Therapeutic Proteins July 2005 - March 2009
University of Colorado Health Sciences 2001 - 2006
FeRx incorporated 1995 - 2002
Colorado school of mines 1991 - 1996
Skills
Analytical method..., CMC writing, formulation development, biophysical..., Biotechnology, Protein Chemistry, Biopharmaceuticals, Formulation, Regulatory Submissions, Project Management, Laboratory, Product Development, Leadership, GMP, Technology Transfer, HPLC, Drug Delivery
Education
University of Colorado Health Sciences Center 2001 — 2006
Doctor of Philosophy (PhD), Pharmaceutical Sciences, under John Carpenter
Colorado School of Mines 1991 — 1996
B.S., Chemical Engineering
Lizzie Leininger's Biologics Consulting Group Experience October 2001 - March 2005
Job Consultant for Regulatory Affairs and Quality
Industry Biotechnology
Experience
Regulatory Affairs and Quality August 2008 - Present
StemCells, Inc April 2006 - July 2008
BAS Medical March 2005 - March 2006
Biologics Consulting Group October 2001 - March 2005
GlaxoSmithKline January 2000 - October 2001
Chiron Corporation October 1992 - January 2000
FDA, CBER September 1987 - September 1992
Skills
Technical Writing, FDA, Regulatory Affairs, Regulatory Submissions, Regulatory Requirements, Biotechnology, Quality Assurance, Quality System, Quality Auditing, Drug Development, Cell Therapy, GMP, GCP, Pharmaceutical Industry, Biopharmaceuticals, IND, CAPA, Clinical Development, Biologics, GxP
Education
University of North Carolina at Chapel Hill 1983 — 1987
PhD, Chemistry, Protein Chemistry
University of Puerto Rico, Mayaguez Campus 1979 — 1983
B.S., Chemistry
Regulatory Affairs and Quality August 2008 - Present
StemCells, Inc April 2006 - July 2008
BAS Medical March 2005 - March 2006
Biologics Consulting Group October 2001 - March 2005
GlaxoSmithKline January 2000 - October 2001
Chiron Corporation October 1992 - January 2000
FDA, CBER September 1987 - September 1992
Skills
Technical Writing, FDA, Regulatory Affairs, Regulatory Submissions, Regulatory Requirements, Biotechnology, Quality Assurance, Quality System, Quality Auditing, Drug Development, Cell Therapy, GMP, GCP, Pharmaceutical Industry, Biopharmaceuticals, IND, CAPA, Clinical Development, Biologics, GxP
Education
University of North Carolina at Chapel Hill 1983 — 1987
PhD, Chemistry, Protein Chemistry
University of Puerto Rico, Mayaguez Campus 1979 — 1983
B.S., Chemistry
Raphael Bartholomeusz's Biologics Consulting Group Experience 2002 - 2007
Job President, Apogee Clinical Inc.
Industry Biotechnology
Experience
Apogee Clinical Inc March 2007 - Present
Biologics Consulting Group 2002 - 2007
Skills
Clinical Development, Clinical Trials, Data Management, GCP, Biotechnology, Drug Development, Regulatory Affairs, Biopharmaceuticals, Clinical Research, Life Sciences, FDA, Pharmaceutical Industry
Education
University of Melbourne
PhD
Apogee Clinical Inc March 2007 - Present
Biologics Consulting Group 2002 - 2007
Skills
Clinical Development, Clinical Trials, Data Management, GCP, Biotechnology, Drug Development, Regulatory Affairs, Biopharmaceuticals, Clinical Research, Life Sciences, FDA, Pharmaceutical Industry
Education
University of Melbourne
PhD
Nebojsa-Micki Djordjevic's Biologics Consulting Group Experience January 2008 - June 2009
Job Director Analytical Development at Pacira Pharmaceuticals, Inc.
Industry Biotechnology
Experience
Pacira Pharmaceuticals, Inc. December 2014 - Present
Colorado Mountain College January 2014 - Present
SANO CRO July 2009 - Present
Biologics Consulting Group January 2008 - June 2009
cytokinetics 2001 - 2007
Novartis Pharma April 1988 - September 2001
Skills
Biotechnology, Biopharmaceuticals, Analytical Chemistry, GMP, Technology Transfer, FDA, Quality Assurance, Drug Discovery, Quality System, Validation, Lifesciences, Drug Development, Regulatory Affairs, 21 CFR Part 11, GLP, Pharmaceutical Industry, Clinical Development, Regulatory Submissions, Sop, CRO, Vaccines, GxP, Clinical Trials, Protein Chemistry, HPLC, Chromatography, R&D, LIMS, Biochemistry, V&V, Immunology, CAPA, Chemistry, Life Sciences, SOP
Education
Brigham Young University 1986 — 1988
Post Doc, Analytical Chemistry
University of California, San Diego 1983 — 1986
Doctor of Philosophy (PhD), Analytical Chemistry, 4.0
Pacira Pharmaceuticals, Inc. December 2014 - Present
Colorado Mountain College January 2014 - Present
SANO CRO July 2009 - Present
Biologics Consulting Group January 2008 - June 2009
cytokinetics 2001 - 2007
Novartis Pharma April 1988 - September 2001
Skills
Biotechnology, Biopharmaceuticals, Analytical Chemistry, GMP, Technology Transfer, FDA, Quality Assurance, Drug Discovery, Quality System, Validation, Lifesciences, Drug Development, Regulatory Affairs, 21 CFR Part 11, GLP, Pharmaceutical Industry, Clinical Development, Regulatory Submissions, Sop, CRO, Vaccines, GxP, Clinical Trials, Protein Chemistry, HPLC, Chromatography, R&D, LIMS, Biochemistry, V&V, Immunology, CAPA, Chemistry, Life Sciences, SOP
Education
Brigham Young University 1986 — 1988
Post Doc, Analytical Chemistry
University of California, San Diego 1983 — 1986
Doctor of Philosophy (PhD), Analytical Chemistry, 4.0
Nanda Subbarao's Biologics Consulting Group Experience June 2007 - Present
Job Senior Consultant at Biologics Consulting Group
Industry Biotechnology
Experience
Biologics Consulting Group June 2007 - Present
Sun Pharmaceuticals 2006 - 2007
Sandoz 2003 - 2006
Pfizer 1998 - 2003
Organics L.L.C. (a Solvay Pharmaceuticals company) 1995 - 1998
Skills
GMP, Biopharmaceuticals, Validation, Pharmaceutical Industry, FDA, Biotechnology, GLP, Regulatory Affairs, Technology Transfer, Lifesciences, Regulatory Submissions, Sop, CAPA, GxP, Clinical Development, Drug Discovery, Quality System, V&V, R&D, Change Control, Drug Development, 21 CFR Part 11, Quality Assurance, Life Sciences, SOP, HPLC, Laboratory, Protein Chemistry, Chromatography, Clinical Trials, Medical Devices
Education
Indian Institute of Technology, Bombay 1980 — 1985
Ph.D, Chemistry
Biologics Consulting Group June 2007 - Present
Sun Pharmaceuticals 2006 - 2007
Sandoz 2003 - 2006
Pfizer 1998 - 2003
Organics L.L.C. (a Solvay Pharmaceuticals company) 1995 - 1998
Skills
GMP, Biopharmaceuticals, Validation, Pharmaceutical Industry, FDA, Biotechnology, GLP, Regulatory Affairs, Technology Transfer, Lifesciences, Regulatory Submissions, Sop, CAPA, GxP, Clinical Development, Drug Discovery, Quality System, V&V, R&D, Change Control, Drug Development, 21 CFR Part 11, Quality Assurance, Life Sciences, SOP, HPLC, Laboratory, Protein Chemistry, Chromatography, Clinical Trials, Medical Devices
Education
Indian Institute of Technology, Bombay 1980 — 1985
Ph.D, Chemistry
Julia Lukas's Biologics Consulting Group Experience 2002 - October 2004
Job Dir. Sterile Compliance at Merck
Industry Pharmaceuticals
Experience
Merck February 2009 - Present
sanofi pasteur October 2004 - January 2009
Biologics Consulting Group 2002 - October 2004
CBER - FDA 1995 - 2001
Skills
Microbiology, Vaccines, GMP, Aseptic Processing, Biologics, FDA, Regulatory Affairs, Quality Control, Pharmaceutical Industry, Quality Auditing, Biopharmaceuticals, Biotechnology, Pharmaceutics, Infectious Diseases, Sterilization
Education
Fordham University 1984 — 1988
BS
Merck February 2009 - Present
sanofi pasteur October 2004 - January 2009
Biologics Consulting Group 2002 - October 2004
CBER - FDA 1995 - 2001
Skills
Microbiology, Vaccines, GMP, Aseptic Processing, Biologics, FDA, Regulatory Affairs, Quality Control, Pharmaceutical Industry, Quality Auditing, Biopharmaceuticals, Biotechnology, Pharmaceutics, Infectious Diseases, Sterilization
Education
Fordham University 1984 — 1988
BS
Kerin Ablashi's Biologics Consulting Group Experience May 2005 - Present
Job Consultant at Biologics Consulting Group
Industry Biotechnology
Experience
Biologics Consulting Group May 2005 - Present
BioSynexus 2001 - 2005
BioReliance 1991 - 2001
Skills
Pharmaceutical Industry, Validation, FDA, Lifesciences, GMP, Biopharmaceuticals, Biotechnology
Education
Hood College
M.S., Environmental Biology
University of Maryland College Park 1985 — 1989
B.S., Biology (Zoology)
Biologics Consulting Group May 2005 - Present
BioSynexus 2001 - 2005
BioReliance 1991 - 2001
Skills
Pharmaceutical Industry, Validation, FDA, Lifesciences, GMP, Biopharmaceuticals, Biotechnology
Education
Hood College
M.S., Environmental Biology
University of Maryland College Park 1985 — 1989
B.S., Biology (Zoology)
L. Bruce Pearce, Ph.D.'s Biologics Consulting Group Experience 2010 - Present
Job Senior Consultant at Biologics Consulting Group
Industry Biotechnology
Experience
Biologics Consulting Group 2010 - Present
Ariadne: Therapeutics Development Sciences September 2009 - 2010
Biopure 2005 - 2008
Biopure Corporation 2001 - 2005
Skills
Biotechnology, Biopharmaceuticals, Drugs, Medical Devices, Pharmacology, Toxicology Testing, Toxicology Study Design, GLP Evaluation, Toxicological Risk..., Biocompatibility Testing, ISO 10993 Testing, CRO Testing Management, Nonclinical Testing..., Pharmacokinetics, Translational..., Clinical Pharmacology, Regulatory Submissions, INDs, ANDAs, NDAs, BLAs, Vaccines, Recombinant Proteins, Blood Substitues, Oncology Drugs, Biosimilars, Monoclonal Antibodies, FDA, Clinical Trials, Clinical Development, Oncology, Pharmaceutical Industry, GCP, Clinical Research, Nanotechnology, Biologics, Biocompatibility, Drug Development, Drug Discovery, GLP, Lifesciences, Technology Transfer, CRO, Toxicology, IND, Regulatory Affairs, Validation, Life Sciences
Education
Harvard Medical School 1985 — 1987
Postdoc, Pharmacology
Yale University School of Medicine 1983 — 1985
Postdoc, Pharmacology
State University of New York College at Buffalo 1978 — 1983
Ph.D., Pharmacology
University of Massachusetts Boston 1974 — 1978
BA, Chemistry and Biology
Biologics Consulting Group 2010 - Present
Ariadne: Therapeutics Development Sciences September 2009 - 2010
Biopure 2005 - 2008
Biopure Corporation 2001 - 2005
Skills
Biotechnology, Biopharmaceuticals, Drugs, Medical Devices, Pharmacology, Toxicology Testing, Toxicology Study Design, GLP Evaluation, Toxicological Risk..., Biocompatibility Testing, ISO 10993 Testing, CRO Testing Management, Nonclinical Testing..., Pharmacokinetics, Translational..., Clinical Pharmacology, Regulatory Submissions, INDs, ANDAs, NDAs, BLAs, Vaccines, Recombinant Proteins, Blood Substitues, Oncology Drugs, Biosimilars, Monoclonal Antibodies, FDA, Clinical Trials, Clinical Development, Oncology, Pharmaceutical Industry, GCP, Clinical Research, Nanotechnology, Biologics, Biocompatibility, Drug Development, Drug Discovery, GLP, Lifesciences, Technology Transfer, CRO, Toxicology, IND, Regulatory Affairs, Validation, Life Sciences
Education
Harvard Medical School 1985 — 1987
Postdoc, Pharmacology
Yale University School of Medicine 1983 — 1985
Postdoc, Pharmacology
State University of New York College at Buffalo 1978 — 1983
Ph.D., Pharmacology
University of Massachusetts Boston 1974 — 1978
BA, Chemistry and Biology
Tanya Scharton-Kersten's Biologics Consulting Group Experience April 2001 - September 2007
Job Senior Director, Regulatory Affairs and Quality Assurance at International AIDS Vaccine Initiative (IAVI)
Industry Pharmaceuticals
Experience
International AIDS Vaccine Initiative (IAVI) May 2014 - Present
Novartis Vaccines and Diagnostics August 2009 - April 2014
Novartis Vaccines and Diagnostics March 2008 - August 2009
Novartis Vaccines and Diagnostics September 2007 - March 2008
Biologics Consulting Group April 2001 - September 2007
Scharton Consulting April 2000 - April 2001
Iomai Corporation December 1998 - April 2000
Iomai Corporation September 1997 - November 1998
The National Institutes of Health, NIAID January 1995 - August 1997
Skills
Biopharmaceuticals, GMP, Regulatory Affairs, Laboratory, Immunology, CMC, Vaccines, Pharmaceutical Industry, Quality System, Microbiology, Biotechnology, Technology Transfer, FDA, Validation
Education
University of Pennsylvania 1990 — 1995
Ph.D.
University of California, Berkeley 1986 — 1990
B.A.
International AIDS Vaccine Initiative (IAVI) May 2014 - Present
Novartis Vaccines and Diagnostics August 2009 - April 2014
Novartis Vaccines and Diagnostics March 2008 - August 2009
Novartis Vaccines and Diagnostics September 2007 - March 2008
Biologics Consulting Group April 2001 - September 2007
Scharton Consulting April 2000 - April 2001
Iomai Corporation December 1998 - April 2000
Iomai Corporation September 1997 - November 1998
The National Institutes of Health, NIAID January 1995 - August 1997
Skills
Biopharmaceuticals, GMP, Regulatory Affairs, Laboratory, Immunology, CMC, Vaccines, Pharmaceutical Industry, Quality System, Microbiology, Biotechnology, Technology Transfer, FDA, Validation
Education
University of Pennsylvania 1990 — 1995
Ph.D.
University of California, Berkeley 1986 — 1990
B.A.
Sarah McNulty's Biologics Consulting Group Experience 2001 - 2007
Job Vice President, Regulatory Affairs at Relypsa
Industry Biotechnology
Experience
Relypsa October 2014 - Present
Relypsa December 2012 - September 2014
Relypsa September 2010 - December 2012
FibroGen September 2007 - September 2010
Biologics Consulting Group 2001 - 2007
Aviron 1999 - 2001
CCS Associates 1997 - 1999
Education
University of California, Irvine 1990 — 1996
B.S. Biology, Ecology and Evolutionary Biology Emphasis; Dance Minor
Relypsa October 2014 - Present
Relypsa December 2012 - September 2014
Relypsa September 2010 - December 2012
FibroGen September 2007 - September 2010
Biologics Consulting Group 2001 - 2007
Aviron 1999 - 2001
CCS Associates 1997 - 1999
Education
University of California, Irvine 1990 — 1996
B.S. Biology, Ecology and Evolutionary Biology Emphasis; Dance Minor
Norman W. Baylor's Biologics Consulting Group Experience October 2011 - Present
Job President and CEO at Biologics Consulting Group
Industry Biotechnology
Experience
Biologics Consulting Group October 2011 - Present
US Food and Drug Administration May 2005 - October 2011
US Food and Drug Administration January 2005 - May 2005
US Food and Drug Administration September 1994 - January 2005
US Food and Drug Administration January 1993 - September 1994
US Food and Drug Administration July 1991 - December 1992
Skills
Virology, vaccine clinical..., Infectious Diseases, FDA, global public health..., Regulatory Affairs, Regulatory Submissions, CMC for vaccines, Biotechnology, Clinical Trials, Vaccines, Public Health, Lifesciences, Biopharmaceuticals, Clinical Development, Drug Development, Microbiology, Technology Transfer, Immunology, Drug Discovery, GLP, Biochemistry, Assay Development, Life Sciences
Education
University of Kentucky 1979 — 1985
MS and PhD, Microbiology
University of Wisconsin-Madison 1974 — 1978
Bachelor of Science (BS), Medical Microbiology
West Side High School
West Side High School
Biologics Consulting Group October 2011 - Present
US Food and Drug Administration May 2005 - October 2011
US Food and Drug Administration January 2005 - May 2005
US Food and Drug Administration September 1994 - January 2005
US Food and Drug Administration January 1993 - September 1994
US Food and Drug Administration July 1991 - December 1992
Skills
Virology, vaccine clinical..., Infectious Diseases, FDA, global public health..., Regulatory Affairs, Regulatory Submissions, CMC for vaccines, Biotechnology, Clinical Trials, Vaccines, Public Health, Lifesciences, Biopharmaceuticals, Clinical Development, Drug Development, Microbiology, Technology Transfer, Immunology, Drug Discovery, GLP, Biochemistry, Assay Development, Life Sciences
Education
University of Kentucky 1979 — 1985
MS and PhD, Microbiology
University of Wisconsin-Madison 1974 — 1978
Bachelor of Science (BS), Medical Microbiology
West Side High School
West Side High School
Norman Baylor's Biologics Consulting Group Experience October 2011 - Present
Job President and CEO at Biologics Consulting Group
Industry Biotechnology
Experience
Biologics Consulting Group October 2011 - Present
The US Food and Drug Administrarion June 1991 - October 2011
National Cancer Institute September 1988 - June 1991
University of Virginia October 1985 - September 1988
Education
University of Kentucky 1982 — 1985
PhD, molecular microbiology
University of Kentucky 1979 — 1982
MS, microbial genetics
University of Wisconsin-Madison 1974 — 1978
BS, medical microbiology
Biologics Consulting Group October 2011 - Present
The US Food and Drug Administrarion June 1991 - October 2011
National Cancer Institute September 1988 - June 1991
University of Virginia October 1985 - September 1988
Education
University of Kentucky 1982 — 1985
PhD, molecular microbiology
University of Kentucky 1979 — 1982
MS, microbial genetics
University of Wisconsin-Madison 1974 — 1978
BS, medical microbiology
Debra Barngrover's Biologics Consulting Group Experience April 2011 - Present
Job Senior Consultant at Biologics Consulting Group
Industry Biotechnology
Experience
Biologics Consulting Group April 2011 - Present
Genzyme 1989 - 2010
Integrated Genetics 1985 - 1989
Elf Biorecherches 1983 - 1985
Skills
Bioprocess Development, Supply Chain/Cold Chain..., Program Management, Supply Chain, Regulatory Filings, Biotechnology, Lifesciences, Regulatory Affairs, GMP, FDA, Biopharmaceuticals, Regulatory Submissions, R&D, Bioprocessing, Supply, Chain, Optimizations, Communications Audits, Biochemistry, Drug Development, Technology Transfer, Biologics, Protein Chemistry, Optimization, V&V, Process Simulation, Change Control, Drug Discovery
Education
Cornell University
Ph.D, Nutritional Biochemistry, Computer Science
Biologics Consulting Group April 2011 - Present
Genzyme 1989 - 2010
Integrated Genetics 1985 - 1989
Elf Biorecherches 1983 - 1985
Skills
Bioprocess Development, Supply Chain/Cold Chain..., Program Management, Supply Chain, Regulatory Filings, Biotechnology, Lifesciences, Regulatory Affairs, GMP, FDA, Biopharmaceuticals, Regulatory Submissions, R&D, Bioprocessing, Supply, Chain, Optimizations, Communications Audits, Biochemistry, Drug Development, Technology Transfer, Biologics, Protein Chemistry, Optimization, V&V, Process Simulation, Change Control, Drug Discovery
Education
Cornell University
Ph.D, Nutritional Biochemistry, Computer Science
Boucher Phil's Biologics Consulting Group Experience March 2014 - September 2014
Job Scientific Affairs Director at PRA Health Sciences
Industry Pharmaceuticals
Experience
PRA Health Sciences September 2014 - Present
Biologics Consulting Group March 2014 - September 2014
Novartis Vaccines and Diagnostics February 2006 - December 2013
FDA April 1994 - January 2006
Institut Pasteur 1990 - 1994
Skills
Biotechnology, Lifesciences, Biochemistry, Cell Culture, Pharmaceutical Industry, Molecular Biology, GMP, Sop, HPLC, Protein Purification, Clinical Trials, ELISA, Western Blotting, Validation, Chromatography, Immunology, PCR, Technology Transfer, Cell Biology, Microbiology
Education
University of California, Davis 1984 — 1989
Ph.D., Biochemistry
University of Oregon 1980 — 1984
Bachelor of Science (B.S.), Biology, General
International school manila
PRA Health Sciences September 2014 - Present
Biologics Consulting Group March 2014 - September 2014
Novartis Vaccines and Diagnostics February 2006 - December 2013
FDA April 1994 - January 2006
Institut Pasteur 1990 - 1994
Skills
Biotechnology, Lifesciences, Biochemistry, Cell Culture, Pharmaceutical Industry, Molecular Biology, GMP, Sop, HPLC, Protein Purification, Clinical Trials, ELISA, Western Blotting, Validation, Chromatography, Immunology, PCR, Technology Transfer, Cell Biology, Microbiology
Education
University of California, Davis 1984 — 1989
Ph.D., Biochemistry
University of Oregon 1980 — 1984
Bachelor of Science (B.S.), Biology, General
International school manila
Blair Fraser's Biologics Consulting Group Experience January 2009 - Present
Job Senior Consultant at Biologics Consulting Group
Industry Biotechnology
Experience
Biologics Consulting Group January 2009 - Present
Skills
Biotechnology, Biopharmaceuticals, Lifesciences, FDA, Pharmaceutical Industry, Regulatory Affairs, Regulatory Submissions, Drug Development, Vaccines, Drug Discovery, R&D, Change Control, Biochemistry, Immunology, GLP, 21 CFR Part 11, SOP, Life Sciences
Education
Penn State University
Biologics Consulting Group January 2009 - Present
Skills
Biotechnology, Biopharmaceuticals, Lifesciences, FDA, Pharmaceutical Industry, Regulatory Affairs, Regulatory Submissions, Drug Development, Vaccines, Drug Discovery, R&D, Change Control, Biochemistry, Immunology, GLP, 21 CFR Part 11, SOP, Life Sciences
Education
Penn State University