PETER FORSTER, Ph.D.

 6 Lara Lane
Wilmington, DE 19808 peter@forster-solutions.com 		Phone:
Fax: 		302-998-8099
302-998-8097

SUMMARY:
IT Expert in Pharmaceutical and Financial Industries, with extensive scientific background; over 20 years in IT solutions engineering, standards and policy design, systems management and validation, and professional software development; built 2 data centers from the ground up

PROFESSIONAL:
09/2002 -
present 		Forster Solutions, LLC, Wilmington, DE
President - Information Technology Consulting
  
 
Novartis Pharmaceuticals, East Hanover, NJ (07/2008 - present)
Scientific Solutions Architect, Modeling & Simulation
    Solution Architect for 2 Projects:
•Implementation of a customized 3rd party application for comparing, managing, reporting NONMEM pharmacokinetic modeling calculations, and inserting graphs and tables into submission documents
•Design and implementation of a custom-developed 3rd party application to serve as a knowledge repository for drug and disease models
    Collection and documentation of user requirements specifications, functional design specifications and Request For Proposal (RFP)
    Analysis of available applications and technologies and execution of evaluation and selection process for potential vendors
    Documentation of solution architecture design, infrastructure requirements
    Collaboration with the vendor to ensure business requirements are understood and implemented correctly, and match the way users (scientists) work; including detailed discussions of technical and infrastructure issues, as well as user experience and usability demands and regulatory requirements
    Participation in all aspects of the validation process, including analysis of risk factors and regulatory (FDA) exposures; management of unit testing, system testing and user acceptance testing (UAT), as well as IQ/OQ
  
 
Merck & Co., West Point, PA (05/2008 - 07/2008)
Enterprise Architecture Consultant, Modeling & Simulation
    Assess and document business capabilities and gaps for various modeling and simulation efforts in different research, pre-clinical and clinical areas
    Design process and information models for common requirements
    Define technology solutions architecture within global enterprise framework
    Develop a road map of initiatives necessary to implement business strategy
  
 
Bristol-Myers Squibb, Princeton, NJ (03/2005 - 12/2007)
Scientific Solutions Architect & Project Manager
eMASTER Project, Strategic Modeling & Simulation
    Implemented a custom, scientific application for comparing, managing and reporting NONMEM population pharmacokinetic modeling and simulation calculations, which increased productivity by at least a factor of 10
    Performed complete application architecture design and development
    Developed fully functional Prototype in only 2 weeks
    Designed and built multi-server networked 3-tier application with web-based front-end, session daemons and compute server farm back-end, developed in Perl, AJAX, HTML and JavaScript
    Developed modules for advanced methods such as Bootstrap and Covariate Model Building, as well as graphical visualizations (diagnostic plots) with S-Plus
    Built automatic generation of different report tables in RTF format for direct inclusion in regulatory submissions to FDA
    Performed full life-cycle project management, requirements analysis, vision statement, project plan development, execution, tracking and status reporting; team selection; budget & resource management
    Managed the entire validation process, including analysis of risk factors and regulatory (FDA) exposures; management of unit testing, system testing and user acceptance testing (UAT), as well as IQ/OQ
    Developed policies, standards and documentation, including User Guide (100+ pages) and Administrator Manual; provided extensive user training for the entire application
  
 
Bristol-Myers Squibb, Princeton, NJ (10/2002 - 06/2008)
Capability Manager & Project Manager
Biotransformation Database Project
    Implemented a custom electronic lab notebook (ELN) application for storage and management of metabolism research information from conception to finish, a multi-year, million-dollar project
    Performed requirements analysis, project plan development, execution, tracking and status reporting; team selection; budget & resource management
    Evaluated and recommended vendors, executed Request For Purchase (RFP) process, managed relationships, negotiated contracts and priority re-alignments, managed scope & resource change
    Designed application & specifications documentation in collaboration with vendor, including metadata definitions, storage & searching of non-specific (Markush) structures, filtering pathway diagrams, instrument data upload, and data analysis
    Redesigned business processes to enable scientists to generate and capture data much more efficiently, and to assure full user acceptance and ownership
    Developed policies, standards, documentation and how-to guides
    Analysed risk factors and regulatory (FDA) exposures for system validation assessment; prepared for application validation

05/2001 -
09/2002		 BlackRock, Inc., Wilmington, DE
Vice President - Technology
  Built Unix (SUN/Solaris) data center environment, consisting of 250+ servers; hired Unix System and Network Administration team, defined objectives and performance metrics, conducted performance reviews, time and resource management, conflict resolution, mentoring, and team motivation
  Presented strategic plans, architecture designs, and process improvements to executive management
  Developed and implemented corporate Change Management Process, Capacity Planning Strategy, Security Standards, and Backup Architecture, and created standard operating procedures (SOPs); prepared audit deliverables
  Prepared, implemented, and executed Disaster Recovery procedures
  Led several large-scale infrastructure implementation projects, as well as new client implementations (ASP)
  Implemented tools for intrusion detection (IDS), SPAM filtering, web site blocking
  Designed Storage Area Network, conducted Enterprise Management package evaluations, and performed Return-On-Investment (ROI) analysis
  Established vendor relationships and negotiated contracts

02/2000 -
04/2001		 DuPont Pharmaceuticals Co., Wilmington, DE
Principal Research Scientist - Discovery Informatics and Molecular Design
  Primary liaison between R&D and IT to develop computing infrastructure and technology direction, and design an architecture that meets the needs of scientists
  Integrated West Coast research laboratories (infrastructure, processes, methods)
  Co-developed DI Browser architecture and design, distributed database concepts, metadata definitions, user interface, search engines, and knowledge management
  Participated in methodology development for applications of information theory, molecular superposition and docking, and clustering methods
  Managed SUN and SGI servers

08/1995 -
01/2000		 DuPont Pharmaceuticals Co., Wilmington, DE
Manager - Shared Technology Solutions
  Supervised staff of fifteen, conducted performance reviews, mentored and coached
  Engineered solutions for all technologies for the entire company (UNIX, VMS, OS400, NT Servers, Network Infrastructure, Desktops, etc.) in FDA regulated environment; directed and implemented strategy; maintained client relationships
  Managed numerous projects through full life cycle (SDLC), including budgeting, resource, scope and change management, risk assessment, contingency planning, and status reporting
  Led requirements and gap analyses, wrote functional and design specifications
  Team Leader - Systems Engineering
  Developed system qualification procedures (IQ/OQ/PQ: Installation Qualification, Operational Qualification, Performance Qualification) and validation plans, performed data center audits, 21 CFR Part 11 regulatory compliance reviews
  Responsible for engineering solutions for all server platforms for the company, architecture decisions, equipment purchases, budget accounting
  Created solutions to automate and integrate business processes for clinical trials, FDA submissions, and data warehouse efforts
  Built high-availability cluster (MC/ServiceGuard) for mission-critical applications
  Supervised team of employees and contractors; performed project and staff management, training, performance reviews; hired new employees
  
  UNIX Team Leader
  Designed, and implemented, the HP-UNIX server environment (subject to FDA regulations) for the entire company; architected standard configurations, wrote Security Policy, developed standard operating procedures (SOPs), and maintained and operated all systems for business-critical processing
  Implemented HP OpenView suite of tools for Enterprise Systems Management; customized proactive monitoring of critical systems and applications
  Acted as most senior resource for UNIX issues, and as liaison to database team
  Managed web server and developed code in Shell, Perl, HTML, Java, JavaScript

02/1995 -
06/2001		 Taylor Management Systems, Waukegan, IL
Systems Management Consultant
  Provided systems management support for R&D computing (molecular design, spectroscopy, and clinical statistics) at Abbott Laboratories
  Supported numerous software packages for molecular modeling, numerical computations, and graphical manipulations, as well as their integration into the infrastructure; managed network of over 90 UNIX workstations and servers

1988 -
1994		 Bruker Analytische Messtechnik GmbH, Rheinstetten, Germany
Scientific Software Developer
  Developed new methods and algorithms for analysis of NMR spectroscopic data
  Wrote programs and utilities in C, Fortran, Modula-2, Lisp, Perl, lexx, yacc, etc.

EDUCATION:
1988 - 1994 Technical University of Berlin, Germany
Dr. rer. nat., Natural Sciences (Ph.D.)
1986 - 1987 University of Oklahoma, Norman, Oklahoma
(Scholarship from the Technical University of Berlin, Germany)
M.S., Physical Chemistry (grade point average 4.0)
1982 - 1987 Technical University of Berlin, Germany
Diploma in Physical and Theoretical Chemistry

PUBLICATIONS:
 
P. Forster and B. M. Fung, Chain Ordering in Cyanobiphenyls and Cyanophenylcyclohexanes, J. Chem. Soc., Faraday Trans. 2, 84 (1988).
  P. Forster, A. Khuen, D. Ziessow and R. Wasen, Computer Algebra in Chemistry, Dechema-Monographs vol. 116, pp. 613-622 (1989).
  P. Forster and D. Ziessow, A Program for the Bayesian Analysis of NMR Time Data, Software Development in Chemistry 7, pp. 119-133, D. Ziessow (Ed.), GDCh, Frankfurt am Main (1992).
  P. Arlt, P. Forster and D. Ziessow, COIN: A Command Interpreter to Integrate Programs for Data Processing in Spectroscopy under UNIX, Software Dev. in Chemistry 7, pp. 315-320, D. Ziessow (Ed.), GDCh, Frankfurt am Main (1992).


WORKSHOPS & TRAINING:
  Temple Univ., Pharmacy QA/RA Graduate Prog.: Drug Development, Spring 2000
  Univ. of Michigan Business School, Exec. Ed. Center: Management II, Nov. 1998
  American Management Association: IS Project Management, Oct. 1998
  DuPont Pharmaceuticals Co., IR Leadership Development, 1998
  Fred Pryor Seminars: Finance and Accounting for Non-Financial Managers, 7/98
  Ouellette & Associates, Consulting Skills for the I/S Professional, June 1998
  DuPont Merck Pharmaceutical Co., Leadership Development Seminar, June 1996
  Hewlett Packard: OpenView IT/Administration, Oct. 1998
  Hewlett Packard: Hands on with MC/ServiceGuard, Aug. 1998
  Hewlett Packard: OpenView NNM Fundamentals for Network Managers, July 1997
  USENIX LISA ’96 Conference: Sendmail, Expect, Javascript courses
  Conference: Maximum Entropy and Bayesian Methods, 1990, 1991, 1993 and 2000

PROFESSIONAL MEMBERSHIPS :
  USENIX Association
  SAGE System Administrators Guild
  American Chemical Society
Division of Computers in Chemistry, Division of Chemical Information

LANGUAGES:
German (native) and English very fluently; basic French; learning Spanish