Project Engineer
Resume:
Shawn A. Knopp Plainfield, IN 46168
abnppn@r.postjobfree.com
Professional Profile
• Strategically oriented pharmaceutical and biotechnology professional with 12 years of
diverse functional management skills in Product Development, Program Management,
and Operations
• Effective leadership skills developed in global clinical, technology transfer, and lean six
sigma projects
• Multi-disciplinary background in business management, pharmaceutical, and
engineering sciences
• Seeking opportunities to influence strategic decision making in the pharmaceutical and
biotechnology industries
Professional Experience
Nov 2006 – Dec 2008 Stiefel Laboratories Raleigh, NC
Director, Product Development & Support
• Leadership support of product development review committee (PDRC) responsible for new
product opportunities, project execution, financial oversight, and milestone review.
• Facilitated the start-up of the R&D global headquarters in Research Triangle Park and
supported resource integration efforts for two mergers by hiring and developing staff of
product development engineers to support 38 clinical projects in oral solid, topical, and foam
based technologies and ongoing commercial manufacturing. Responsible for $5MM budget
for global consolidation of R&D laboratories to RTP and redesign of the clinical trial supply
operating procedures
• Redesigned CMC project team structure to utilize CMC Leaders to facilitate cross-functional
management across Formulation, Engineering, Analytical, Quality, and Regulatory functions
to address CMC strategy and implementation.
• Supported enterprise re-design of global product development processes and interactions
with Supply Chain, IT, and Marketing consistent with Quality by Design concepts.
July 2005-Nov 2006 Baxter Pharmaceutical Solutions Bloomington, IN
Program Manager, Alliance Management
• Responsibilities included project management, account management, and business
development / contract management support for clinical and commercial accounts valued at
30% of BPS revenues.
• Secured a major clinical program from BPS’ largest customer to maintain the long-term
business relationship.
• Managed to earliest resolution several manufacturing stoppages due to technical difficulties
by effectively leading interactions between the client and internal stakeholders across multiple
disciplines.
• Managed a revenue shortfall in 4Q 2005 by negotiating an earlier than planned
manufacturing schedule for BPS’ largest customer.
Jan 2003-July 2005 DSM Pharmaceuticals Greenville, NC
Market Research Scientist
Conducted market research for evaluation of strategic alliances and investments in
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collaboration with DSM Ventures.
Analyzed IMS and Wolters Kluwer databases to conduct business alignment financial case
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studies of the pharmaceutical oral and parenteral markets relative to DSM capabilities and
project performance in support of the business strategic plan.
Supported New Business Development Requests for-Proposals (RFPs) for Sterile and
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Oral/Topical Projects. Defined the scope, timeline, project costs, and resource requirements
for new projects.
Sr. Principal Scientist
Served as the group leader / technical manager for the process transfer and scale-up of
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biotechnology products, including process control projects utilizing enterprise Delta V.
Supported Lean Six Sigma design of experiments approaches to improving operations.
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Efforts resulted in improve process yields for DSM’s largest customer and greater than $2MM
in incremental revenues.
May 1999 – Dec 2002 Wyeth BioPharma Genetics Institute Campus Andover, MA
Project Team Leader, Global Commercial Operations
• Managed the Drug Product Task Force for BeneFIX®. The task force was responsible for
managing non-routine operations for BeneFIX® including manufacturing logistics, deviation
investigations, tech-transfers, lean projects, and monitoring of development activities.
Represented Operations at the Global Strategic Marketing team meetings for BeneFIX®.
• Managed the project team responsible for the process transfer of ReFacto® and ReFacto
AF® at two contract manufacturing facilities. Reviewed and authored appropriate CMC
sections for BLA filings.
• Managed interactions between Development, Operations, Quality Assurance, Regulatory
Affairs, and Contract Manufacturing partners for critical product investigations and other
contract service support.
Staff Scientist, Drug Product Development
• Technical lead for the formulation, process development, manufacturing site selection, and
process validation of ReFacto-AF®, a second generation, albumen free hemophilia drug, and
BMP-2, a bone-morphogenic combination drug / medical device. Authored appropriate BLA
sections for regulatory filings.
• Established a physical characterization laboratory for lyophilized, solid state dosage forms.
Budget included over $500 K for the acquisition of an X-ray diffractometer, NIR-FTIR, MID-
FTIR, DSC, DVS, TGA, BET, and freeze-drying microscope. Utilized solid-state
characterization methods to support product development activities and product deviation
investigations.
• Lead the training effort for the department in lyophilization development, filtration, mixing,
compatibility, freeze-thaw, stopper drying, and adsorption studies.
May 1992 – May 1993 Oak Ridge National Laboratory (DOE) Oak Ridge, Tennessee
Biochemical Engineering Fellowship
Research was conducted in the field of bio-renewable fuels.
• Optimized the nutrient media and growth conditions of microorganisms producing ethanol
from cellulose.
• Characterized the process conditions necessary for stable fluidization and efficient oxygen
mass transfer in a columnar bio-reactor system comprising alginate beads of entrapped
microorganisms.
• Optimized the recovery of ethanol from a 500L pilot scale fluidized-bed bioreactor utilizing
adsorption onto hydroxyapatite particles.
May 1991 – May 1992 Colgate Palmolive Jeffersonville, Indiana
Project Engineer
Managed capital projects within the Personal Care Products area.
• Designed and managed the installation of two compounding lines for toothpaste
manufacture.
• Designed and managed the installation of two filling and packaging lines.
Education
Elon University, Elon, NC Purdue University, West Lafayette, IN
Master of Business Administration, 2009 PhD, Pharmaceutical Sciences, 1999
Purdue University, West Lafayette, IN University of Louisville, Louisville, KY
M.S. courses, Chemical Engineering B.S., Chemical Engineering
Teaching Experiences
Pre-Pharmacy Core Review (Calculus, General Chemistry, Statistics, Physics)
Biopharmaceutics (Drug Delivery, Pharmacokinetics)
Rate Processes
Pharmaceutical Manufacturing
Honors
• Purdue Research Fellowship (1997-1998)
• S.E.R.S. Department of Energy Fellowship recipient (1991)
• Tau Beta Pi Engineering Honor Society
• Phi Eta Sigma Honor Society
• Alpha Epsilon Delta Honor Society
S pecialized Skill Sets
• SAS® Programming and Statistical Software
• Aspen Process Modeling Software
• Graduate level training in Lean Six Sigma methodologies
• Database/Programming languages: SQL, C, Visual Basic, Python
Professional Affiliations
• American Association of Pharmaceutical Scientists (AAPS)
• American Institute of Chemical Engineers (AIChE)
• Parenteral Drug Association (PDA)
Publications and Presentations
Advisor, 5th Lean Six Sigma for Pharmaceutical, Biotech, and Medical Device Excellence, February,
2008
“Vaccine Fill-Finish Unit Operations”, presented at joint IOM / Academy of Engineering Conference,
Engineering Approaches to Pandemic Influenza” March, 2006
“Project Management Fundamentals in Contract Manufacturing”, presented at the Marcus Evans
Generic Drugs Forum, February, 2005
“Fundamentals of Freeze-Drying”, Pharmaceutical Biotechnology, 2002 v14, pp. 281-360
“Influence of Hot-WFI vial washing on the adsorption of proteins to lyophilization vials”, Staff
Seminar, October 2001
“Influence of a serine protease on the freeze-dried cake structure of FIX”, Wyeth-BioPharma Seminar
Series, June 2001
“Physical Chemistry of Glycine Solutions during Freeze-drying”, J. Pharmaceutical Science, v90
2001
“Experimental Considerations for Temperature Modulated DSC at Low Temperature”, J. Thermal
Analysis, v60 2000
“Relationship of the TMDSC Curve of Sucrose Solutions to Collapse during Freeze-drying”, J.
Thermal Analysis, v54 1998
“Stability Characterization and Comparison of Two Fluidized Bed Bioreactors”, Bioprocess Engineer-
ing, 10 1994
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