SUMMARY

Knowledgeable Project Leader with an extensive background in the pharmaceutical industry and CTOs. Effective team-oriented manager with excellent communication skills. Experienced in developing and achieving project timelines and milestones in a GMP environment. Competent and efficient member of multidisciplinary, international, multi-site project teams. Clinical trial experience including the management of multiple projects to schedules. Broad background in project management and compliance requirements. Team-oriented, results-driven person who is committed to achieving timelines and reaching project milestones. Demonstrated leadership, team building and interpersonal skills.

PROFESSIONAL EXPERIENCES

CATALENT PHARMA SOLUTIONS, Kansas City MO 2022-2023

Project Manager, Clinical Development and Supply

Under own direction, coordinate projects from award stage to completion ensuring correct planning timelines are generated, monitored, and tracked for the successful adherence and completion.

Lead the implementation of new clinical and/or commercial projects including source documentation and batch records.

Attend and produce minutes and actions for client meetings, teleconferences, client visits, and audits to support assigned projects or the PM Team and generate all required project documentation.

Utilize and drive Workfront for day-to-day project activities.

Manage inventory reporting and monitor and track client inventory in line with project requirements.

CHARLES RIVER LABORATORIES, Malvern PA 2007-2022

Senior Manager, Project Management, Biopharmaceutical Services

Manages national and international project teams by developing project plans, milestones, and major deliverables. Interacts with clients, investigators, sample processing, technical operations, and quality assurance to ensure timelines are met and deliverables are achieved. Provides periodic updates to clients and provided LIMS management.

Negotiates contracts, statement of works, and overall project scopes for approximately 30 US and global clients including India, Europe, Asia, and the United Kingdom.

Ensures a smooth transfer of international shipments by coordinated USDA, CDC, US Fish & Wildlife permit applications.

Tracked project deliverables and reported Key Performance Indicators (KPIs) to upper management. Manager.

Delivered presentations at Corporate Sales Meetings.

CHARLES RIVER LABORATORIES, Malvern PA 2004-2007

Manager, Client Services, Biopharmaceutical Services

Managed inside sales, including pricing, bid and proposal generation, to ensure smooth and timely business process flow. Ensured LSCA and CDAs were negotiated and finalized. Managed the database tracking system(s) to monitor and report proposal turnaround time, bid proposal volume, and bid effectiveness. Managed departmental resources (workflow) for responsiveness to client needs and effective use of business processes. Managed activities of assigned group to ensure effective performance of function. Assist in the development of short- and long-range operating objectives, organizational structure, and staffing requirements.

Initiated project management approach to priority projects and preferred provide clients which resulted in increased efficiency, coordination of laboratory activities and achievement of timelines.

Increased effective communication between technical staff, scientists, and clients which ensured a smooth project flow.

Created weekly reports/updates to upper management enabling a constant flow of information.

AVENTIS PASTEUR, Swiftwater, PA 2001-2003

Platform Leader, Clinical Immunology, North American Analytical Sciences & Assay Development

Managed laboratory in support of vaccine clinical trials. Interacted with clinical development/operations, clinical QA, regulatory affairs and data management to ensure completion of clinical trials according to the project timelines. Negotiated contracts, developed budgets and managed various projects involving external vendors and consultants. Represented the platform on project teams to coordinate clinical testing, data management and protocol/CSR review. Created, tracked and distributed periodic project status reports to the project teams, senior management and customers. Reviewed, edited and approved SOPs, protocols, reports, and has experienced with regulatory guidelines.

Increased the size of the Clinical Immunology Platform from less than 20 to approximately 50 scientists and technicians enabling fast response time on testing demands and priority projects.

Participated in data audits and installed measures to ensure the data integrity and compliance with SOPs/ protocols. Results were increased efficiency and expedited data analysis.

Served as integral member of global project teams including the centralization of Clinical Immunology between the French and Canadian laboratories, successfully transferring assays from these sites.

Research Scientist, Clinical Immunology, Swiftwater, PA 1997-2001

Developed statistical approach for the analysis of assay data resulting in FDA approval of the assays.

Transferred assays into new laboratory on site.

Managed contractors responsible for the GMP validation according to regulatory guidelines.

Managed contractors responsible for the validation of a computer software program.

BALTIMORE VA HOSPITAL, Baltimore, MD 1996-1997

Managing Director, Clinical Research Unit

Coordinated and supervised pharmacokinetic drug trials; oversaw budgets, consent forms/IRB approval and source documentation and recruiting, and scheduling.

Developed/negotiated/managed study budgets and timelines.

Developed source documentation and coordinated protocol execution.

Supervised the clinical and administrative staff, obtained IRB approval, and hired personnel to execute protocols.

Supervised subject recruitment and interacted with investigators, sponsors, and hospital administrators.

UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE, Baltimore, MD 1992-1997

Assistant Professor, Dept. of Medical and Research Technology

Served as Discipline leader for the Clinical Chemistry group. Presented lectures on Biochemistry, Clinical Chemistry and Statistics. Served as Principal Investigator for clinical trials involving glucose monitors, oversaw budgets, consent forms/IRB approval, recruiting, and scheduling.

Conducted basic research involving superoxide production in human neutrophils resulting in potential effects of caffeine on the immune system.

HOWARD COMMUNITY COLLEGE, Columbia, MD 1990-1997

Adjunct Professor of Chemistry, Science Dept.

Lectured on Organic Chemistry.

USDA/ARS/BHNRC, LIPID NUTRITION LABORATORY, Beltsville, MD 1989-1992

Postdoctoral/Research Associate

Conducted basic research involving ionized calcium fluxes in rat platelets.

Involved in a clinical trial evaluating the effect of trans fatty acids on lipid profiles in human volunteers.

AWARDS AND GRANTS

1997 Excellence in Education and Inspirational Guidance in the Teaching and Practice of Medicine, Univ. of MD School of Medicine, Dept. of Medical & Research Technology

1995, 96, 97 Continuous Outstanding Contribution Award, Boehringer Mannheim Corporation

1985, 87 Graduate Student Research Grant, College of Graduate Studies, Cleveland State University, Cleveland, Ohio

1983 American Institute for Chemists, King's College, Wilkes-Barre, PA

EDUCATION

Ph.D., Clinical Chemistry, Cleveland St. Univ., Cleveland, Ohio 1989

M.S., Clinical Chemistry, Cleveland St. Univ., Cleveland, Ohio 1985

B.S., Chemistry, King's College, Wilkes-Barre, PA 1983

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