Manager Management
Resume:
Francis Anders
Delivering Projects On Time, Within Budget and Ensuring Quality Control
Extensive Knowledge in the Clinical and Life Science Industry 7861
Crosswinds Way
Mount Dora, FL 32757
**********@***.***
Motivated, results-oriented self-starter with 20+ years of experience in
project management, plan development, regulatory compliance (HIPAA, CAP,
CLIA, GCP, NIDA, GCP, ISO, FDA), performance metrics research and
reporting, multi-vendor team management, budget control, operations, and
process and product validation. Background spans the pharmaceutical, life
sciences, and biotechnology industries, successfully directing projects
from early clinical/laboratory research stages to final product
manufacture/launch. Highly accomplished in people management, notably,
effective team leadership/development and partner relations. Additional
areas of expertise include:
Quality System Audits . Short- and Long-Term Goals . Policies &
Procedures . Lab Technologies & Operations
Computer Systems Updating & Design ( Standard Business Software & Project
Management Packages
Scheduling & Material Delivery . Data Management & Analysis . Strategic
Planning
Career Highlights
. Established a new function within manufacturing technology, developing
computerized process models and simulations in support of new and
existing systems; the simulations contributed to critical utility system
changes providing a four fold increase in throughput; identified the
root cause for mixing problems on a scale up effort for a biotechnology
process. (Sanofi Pasteur)
. Saved $250K by eliminating simulation project outsourcing and
establishing an effective internal group, increasing the number of
simulation studies from 10-15 to 25. (Sanofi Pasteur)
. Created detailed process design documents for 50 manufacturing processes
and 25 support processes at the plant; supervised 150 employees in
software training. (Sanofi Pasteur)
. Developed and implemented a computerized system validation program,
enabling timely FDA approval for 3 new buildings; directed 50
consultants from 5 contract firms and an internal staff of 5 validation
engineers. (Sanofi Pasteur)
. Managed 20-30 independent contractors in addition to 35 staff
consultants, coordinating nationwide service delivery for projects and
corporate initiatives ranging in cost and scope from small dollar, two-
week-long projects to million-dollar, 18-24 month-long assignments.
(Lloyd's)
. Designed an FDA-approved medical device design control process for a
limited manufacturing facility. (Lloyd's)
. Generated and carried out validation master plans for clients; conducted
audits and assessments geared toward reconciliation of FDA warnings, as
well as consent decree. (Lloyd's)
. Formulated compliance solutions as the laboratory systems' technical
lead for 50 globally-active laboratory systems and instruments, which
necessitated detailed cross-examination of 700+ systems. (Lloyd's)
. Reduced unnecessary, ineffectual processes supported by expensive
software solutions by re-engineering/automating processes and downsizing
personnel with no loss of service levels. Saved $3 M. (Focus
Technologies)
. Formulated and executed an information technology quality system for
clinical laboratory software development. (SmithKline)
Francis Anders
Delivering Projects On Time, Within Budget and Ensuring 484-***-****
Quality Control twfrank111@aol.c
Extensive Knowledge in the Clinical and Life Science Industry om
Page Two
Work Experience
Sanofi Pasteur 2006 - Present
Deputy Director, Process Simulation and Automation Validation
Managed computerized process model and simulation maintenance. Developed
process simulation. Supervised budget analysis and control. Selected
vendors and consultants.
Lloyd's Register Serentec 2002 - 2006
GM and Director, Business Operations
Directed nationwide service delivery for consulting projects and corporate
initiatives. Provided project management and strategy leadership.
Contributed to business development and account management activities.
Director, Southeast Region
Led regional business development, account management, and service delivery
for consulting projects. Provided leadership, guidance, and training to
team members.
Consultant Services (Working with Tecan, Covance, and Schering-Plough
Corporation)
Performed quality system audits for the Quality System and Management
Controls, Quality Audit, and Document Control functions, ensuring
regulatory compliance, optimal workflows, and streamlined operations.
Focus Technologies 2001 - 2002
Director, IT and IT Quality Assurance
Managed all infrastructure, networks, operations, and development teams.
Assured regulatory compliance. Supported sales management in business
objective and proposal development. Was the primary point of contact for
technical sales support on multiple technology platforms.
Quest Diagnostics Incorporated 1999-2001
Manager, LIS Automation Development
Managed software development and software project quality assessment.
Prior to 1999
SmithKline Beecham Clinical Laboratories: Information Resources Manager
QA/Audit/Continuous Improvement Manager
Senior Lab Systems Analyst
Pharmaceuticals Programmer Analyst and Associate Scientist
United States Navy: Clinical Lab Technologist
Education
B.B.A.: Industrial Relations, Ursinus College, Collegeville, PA
. SuperPro Batch/Bio-Process Modeling, Cost Analysis, Production
Scheduling, and De-Bottlenecking Courses
. ASQ Six Sigma Green Belt Certification/ ISPE GAMP 5
. Center for Processional Leadership, Leadership Development Program
. Comprehensive training in Electronic Records and Signatures (21 CFR
Part 11)
. Graduate, SmithKline Beecham Leadership Development Program, Center
for Professional Leadership
. Graduate, Structured Software Testing Program, Rutgers University
. Graduate, Clinical Laboratory Technology Program, USN Medical Center
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