Susan Murphy Meslovich
H:  [Send email to request phone number] 62-7759 W:  [Send email to request phone number] 24-7315 
Address: 6368 Claridge Drive North Frederick, Maryland 21701

 EXPERIENCE SUMMARY 

Qualified Senior Level Manager with extensive experience in personnel planning
and development, start-up and commissioning operations (Manufacturing and
Facilities), trouble-shooting, materials management, biotechnology manufacturing
(monoclonal based), cellular research and quality functions. Well versed in
managing both cGMP and GLP environments as well as with FDA audits and responses
to FDA. Has a diversified background in dealing with cell cultures (primary,
continuous, adherent and non-adherent) and Purification strategies (numerous
resin moieties and strategies). Large scale manufacturing experience in a quality
driven environment with background in technical writing (Start-up protocol's,
SOP's, BLA, Annual Product Reviews (APR), FDA updates etc.), technical service,
performance of quality investigations and reports, experience dealing with
quality and validation issues (e.g. shipping validations, validation design and
executions), development of new equipment, manufacturing area design (e.g.
compliant to cGMP and FDA guidelines) and quality process design.

AREAS OF EXPERTISE

 * EXCELLENT STRATEGIST - Provide solutions that boost productivity and
efficiency across the organization. Quickly identify problem areas and implement
effective solutions to meet goals.
 * EXCEPTIONAL ORGANIZATIONAL SKILLS - Consistently recognized by colleagues for
exceptional talents in needs analysis and problem resolution in fast-paced
environments.
 * ADMINISTRATION AND MANAGEMENT - Knowledgeable of business and management
principles involved in strategic planning, resource allocation, leadership
technique, and coordination of people and resources
 * STRONG SENSE OF RESPONSIBILITY - Solid professional standards; excellent
track record of dependability. Maintain focus on achieving results while
implementing business solutions to meet a diversity of needs.

KEY ACCOMPLISHMENTS

 * Certified Project Manager with expertise in management, facilitation and
building of matrix orientated project teams.
 * Over 12 years of experience working in a cGMP environment and 9 years
experience in cell culture lab techniques including: cell expansion and
adaptation to various medium types, ELISA assays, gel electrophoresis,
vivisection, and radioactive labeling.
 * Independently devised and conducted new research projects focusing on
collagen characterization and use of hollow fiber bioreactors with numerous cell
lines for the production of antibodies.
 * Considered MedImmune, Inc.'s shipping validation expert for bulk drug
substance transportation.
 * Written four publications and contributed to numerous others (not mentioned
as an author).
 * Accomplished Mentor, Senior Manager and Trouble Shooter.

PROFESSIONAL EXPERIENCE

MedImmune, Inc.
Frederick, MD April 1997-Present
Senior Project Manager FMC Facilities/Engineering November 2006-Present
 * Promoted to Senior Project Manager with expanded project and personnel
management responsibilities to include planning, commissioning, and validation of
a newly constructed 350,000 sq.ft. Biologics manufacturing facility.
 * Managed: an over 8 million facility budget; personnel management of 5 direct
and 30 indirect employees; start up of spare parts program for all Facilities and
process equipment; all facility and equipment related contracts; and space
allocation for entire campus.
Project Manager FMC Facilities/Engineering September 2002-November 2006
 * Coordinated project management for facilities and engineering projects,
interacting closely with Operations, Quality Control and Quality Assurance.
 * Solely responsible for the project management of FMC (Frederick Manufacturing
Center) annual shut down activities executing numerous milestones under
aggressive deadlines meeting manufacturing timelines.
Cell Culture Production Manager, Purification/Support February 2001-September
2002
 * Responsible for managing 21 employees across two departments (Purification
and Support), and the production of over 30-60 million dollars worth of Synagis
(the flagship product for MedImmune) product each month.
 * Accounted for general management duties to include budget, personnel/career
development, process improvement, document review and approval, area improvement,
etc.
Project Manager August 1998-February 2001
 * Involved with project management of engineering, validation, quality and shut
down activities for the manufacturing center.
 * Worked with numerous Departments (Contract Manufacturing, QA, Regulatory,
Validation, Materials Management) serving as a troubleshooter on project
difficulties.
 * Responsible for materials management validation operations and reports,
SOP's, Biologic License Application (BLA) submission documentation and projects
as assigned.
Materials Management Warehouse Manager July 1997-August 1998
 * Responsible for staffing and setting up receiving/shipping areas to be in
compliance with FDA requirements for facility drug manufacturing.
 * Involved with the start-up of a new manufacturing plant; responsible for
punch listing the new warehouse area, setting -up flow diagrams for future FDA
licensable facility, writing SOP's, staffing, budgeting, and overall area
management.
 * Accounted for the management of two receiving/shipping areas, nine persons,
promoted to Project Manager September 1998.

Contract Manufacturing Coordinator March 1997 - July 1997
 * Responsible for movement and tracking of human plasma for the production of
MedImmune's two commercial drug products.
 * Involved with the creation and installation of a new computer program used to
better track the plasma movement. Promoted to Materials Management Warehouse
Manager within 4 months.

Cellco, Incorporated
Germantown, MD October 1996-March 1997
Technical Services Manager
 * Responsible for the creation and set-up of a technical services department,
including the documentation and implementation of procedures, and for providing
technical support to customers and new personal.
 * Effectively developed new products to expand the product line.
 * Involved in the strategic placement of products into the market place.
 * Provided technical support at trade shows and meetings.
 * Accounted for the creation of product literature updates and cell culture
manuals.

Unisyn Technologies
Tustin, CA 1992-1996
Technical Service Engineer 1994-July 1996
 * Responsible for the installation, support and repair of hollow fiber
laboratory instruments.
 * Provided technical customer support for hollow fiber, cell maintenance
expansion and monoclonal antibody, viral vector, virus, and recombinant protein
production.
 * Instructed courses in cell culture and system maintenance to customers
throughout the United States, Europe and Canada.
 * Responsible for creating and writing user operation technical manuals for
existing and new products as well as for implementation of Document Request
Changes (DCR) to our existing product line.
 * Involved in development of new products and in the preparation of
Installation Qualification (IQ), Operational Qualification (OQ) and Process
Qualification (PQ) documents for current product line.
Laboratory Associate/Lab Purchasing Agent 1992-1994
 * Responsible for training new personnel in cell culture and laboratory
techniques, maintaining the laboratory, purchasing cell culture supplies and
major analytical equipment.
 * Conducted independent new research projects utilizing hollow fiber for the
production of monoclonal antibodies, viral vectors, and virus and recombinant
proteins.
 * Extensive work performed with cells and purification schemes. Utilization of
the newest analytical equipment for the analysis of purified antibody.

RELEVANT WORK HISTORY

Customer Service Representative: Pan American World Airways Los Angeles, CA
1990-1991

Cell Culturist and Lab Technician: Hillcrest Biological Cypress, CA 1989-1990

Working Lead/Instructor Theme Park Operations: Walt Disney Company Anaheim, CA
1985-1990

Quality Control Supervisor: Coca-Cola Company Downey, CA 1981

EDUCATION

Masters Certificate In Project Management:
George Washington University - School of Business and Public Management
Washington D.C. 2000

Completed 3 Advanced Courses for Masters of Science Degree - Biomedical
Sciences:
Hood College Frederick, MD 1997

Mortuary Science Business and Employee Relations Studies:
 * Continuing Studies with an emphasis in writing improvement and literary
skills
Cypress College Cypress, CA 1986-1992

BS Biology:
University of La Verne La Verne, CA 1985

PUBLICATIONS

Lowrey, D., Murphy, S., and Goff, R.A. (1993) The Effect of intracapillary media
feed protocols on hollow fiber cell cultures. Biotech. Lett. 15, 1025-1030

Lowrey, D., Meslovich, K., Murphy, S., Goff, R.A., and Rybski, V. (1994)
Monoclonal antibody purification using the Mab Pharm. Am. Biotech. Lab., in
press.

Lowrey, D., Murphy, S., Meslovich, K., Veeramallu, U., et al. Small-scale
in-vitro antibody production using a disposable hollow fiber device. The 12th
Meeting of the European Society for Animal Cell Technology (ESACT), Wurzburg,
Germany, May 1993.

Lowrey, D., Murphy, S., and Goffe, R. A., (1994) A comparison of monoclonal
antibody productivity in different hollow fiber bioreactors. Journal of
Biotechnology. 36, 35-38.