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Twenty years experience working within Biotechnology Industry. Helping companies prepare successful regulatory submissions whether it's their first IND or a BLA. Providing strategic direction in areas of CMC, preclinical, and clinical analytical assays (anti-drug antibodies, PK, and biomarkers). Preparation and review of submission documents. Confidential and discreet due diligence. Therapeutic areas include Oncology, Immunology, and Infectious Disease. Experience with monoclonal antibodies/bispecifics, viral-based drug products, peptides, and conjugates.
Apollo Biologics Regulatory Consulting
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Principal ConsultantApollo Biologics Regulatory Consulting Jun 2017 - PresentGreater Los Angeles AreaProviding current, confidential advice on all aspects of drug development to biotechnology companies developing viral-based therapies, monoclonal antibodies, and peptides. Core areas of expertise include CMC, preclinical, clinical analytical development and validation (Anti-drug antibodies, PK, and biomarkers) in a variety of therapeutic areas including oncology, infectious disease, and inflammatory diseases.
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Vp Analytical And Pharmaceutical SciencesCoherus Biosciences May 2016 - Jun 2017Red Wood Shores, Ca -
Executive Director, Biologics Drug DevelopmentMerck Aug 2011 - May 2016Rahway, NjWork within the Biologics division of Merck. Lead cross-functional project teams through all phases of drug development and associated regulatory submissions. Set strategy for programs, effectively negotiate challenges, plan health authority interactions, ensure operational success of programs. Worked on monoclonal antibodies, cytokines, and therapeutic peptides within Oncology, Immunology, and Infectious Diseases. -
Senior DirectorMerck Jun 2010 - Jul 2011Rahway, NjLead a large molecule bioanalytical group after Schering-Plough and Merck merger. Responsible for development and validation of PK and immunogenicity assays in support of toxicology and clinical studies for all biologics programs. Part of Biologics senior leadership team.
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DirectorSchering-Plough Research Institute Nov 2006 - Jun 2010Union, New JerseyDirector of large molecule bioanalytical group. Responsible for development and validation of PK, immunogenicity, and biomarker assays in support of toxicology and clinical studies.
Connie Cullen, Ph.D. Skills
Connie Cullen, Ph.D. Education Details
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University Of Cincinnati College Of MedicineMolecular Biology Immunology -
Children'S Hospital Medical CenterImmunology
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Microbiology And Immunology
Frequently Asked Questions about Connie Cullen, Ph.D.
What company does Connie Cullen, Ph.D. work for?
Connie Cullen, Ph.D. works for Apollo Biologics Regulatory Consulting
What is Connie Cullen, Ph.D.'s role at the current company?
Connie Cullen, Ph.D.'s current role is Apollo Biologics, Principal Consultant.
What is Connie Cullen, Ph.D.'s email address?
Connie Cullen, Ph.D.'s email address is cc****@****rus.com
What is Connie Cullen, Ph.D.'s direct phone number?
Connie Cullen, Ph.D.'s direct phone number is +190882*****
What schools did Connie Cullen, Ph.D. attend?
Connie Cullen, Ph.D. attended University Of Cincinnati College Of Medicine, Children's Hospital Medical Center, Miami University.
What skills is Connie Cullen, Ph.D. known for?
Connie Cullen, Ph.D. has skills like Drug Development, Regulatory Submissions, Biotechnology Industry, Team Leadership, Bioanalysis, Regulatory Guidelines, Immunology, Personnel Management, Glp, Biotechnology, Toxicology, Biologics.
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