Project Manager Customer Service
Resume:
Matthew J. Panning
Hillsborough, NC 27278
919-***-**** (H)
919-***-**** (W)
919-***-**** (C)
***************@*****.***
PROFESSIONAL SUMMARY
A successful, deadline oriented chemist with over 9 years of pharmaceutical experience.
Exceptional customer service and proven leadership ability in pharmaceutical
development, manufacturing, and technical writing.
SKILLS AND ABILITIES
Demonstrated scientific acumen in analytical chemistry and pharmaceutical
•
engineering
Proven ability to effectively present and communicate to a wide range of
•
audiences
Passion for learning and commitment to excellence
•
EXPERIENCE
GlaxoSmithKline, Research Triangle Park, NC May 2002 to Present
Scientist, Pharm Dev, RTP October 2007-present
Project manager for inhaled drug substance asset (Phase IIb)
•
Pilot member of Pharm Dev Job Rotation Program (JRP), from July 2007 to Jan
•
2009
During three 6 month rotations, the following highlights were achieved:
•
• Led self-organized ‘experiental’ visits for RTP JRP to internal groups such
as GMS, MedChem, and the Employee Response Center, as well as an
external visit to two clinical trials facilities associated with UNC Chapel
Hill
• Authored update articles on JRP to global Pharm Dev newsletter
• Presented to home and host departmental meetings on key learnings
Formulations
Developed Tykerb Oral Powder for Reconstitution (OPR) Line Extension
•
Engaged in blending, milling, wet granulation (fluid bed & extrusion),
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compression, coating, and filling operations
Performed powder characterization methods including Flodex, bulk & tap
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density, and sieve analysis
Independently developed powder flow assessment method from recent
•
journal article which led to optimized excipient level in lead formulation
Manufactured clinical and independent development batches of Tykerb
•
OPR
Assisted in drug substance agglomeration investigation targeting particle
•
morphology and size distribution
Contributed to project team meetings on formulation advice
•
Developability & Physical Properties
Performed chemical stability, thermal analysis, formulation preparation
•
and pH solubility profiling in support of typically pre-candidate selection
molecules and salt selection
Utilized PXRD, GVS, TGA, DSC, and HPLC techniques in polymorph
•
investigation; conclusions to be presented as poster at Pre-clinical
development symposium
Performed bead milling and formulation preparation for animal PK and
•
toxicity studies
Gained familiarity with Malvern particle sizing equipment & electron
•
microscopy
Manufacturing Operations, Science and Technology
Assisted installation of on-line TOC monitoring system for pilot plant
•
clean water system
Developed equipment operating procedures
•
Participated in new equipment procurement, including evaluation of
•
design and installation paramaters
Associate Scientist, Pharm Dev, RTP May 2004-October 2007
Performed technical transfers, method & equipment validation, and stability
•
testing in support of development and late phase clinical assets
Expert analyst in content and impurity, dissolution, cascade impaction, moisture,
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polarized light microscopy methods; both automated and manual techniques
Adept technician on HPLC, UV, FLD, ASRS, TPW, Multidose, microscopy
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equipment, including validation, troubleshooting, and proper maintenance
Engaged as lead user on updates, changes, and challenges with the electronic
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laboratory notebook system (Electronic Experiment).
Led and participated in audits, then reported findings to senior leadership as
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auditor for GMP self-inspection team
Served as department safety representative; point of contact for department on
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safety issues such as incident reports, training, and EHS compliance
Generated and peer reviewed data and statistics for compliance, trending and
•
decision-making for FDA submissions using JMP and Statistica software.
Assisted in the quality-reviewing and transcription checking of the NDA and
•
MAA documents
Developed novel approaches to efficient lab practices as member of Lean Lab
•
team.
Presented data, findings, and resolutions at local team and global project team
•
meetings
Investigated out of specification and aberrant data and reported conclusions
•
Assistant Scientist, GMS, Zebulon November 2001-May 2004
Generated accurate, precise quality control data in support of manufacturing
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Performed Cascade Impaction testing on Metered Dose Powdered Inhalers
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Performed content uniformity, assay and impurity analysis on variety of solid
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dosages, utilizing automated TPWII robotics, UV, HPLC, and GC analyses
Reviewed laboratory notebooks for accuracy, completeness, and compliance
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Member of self auditing safety review team
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Hired permanently after 6 month contract to hire term (May 2002)
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Compuchem, Cary, NC May 2000 to September 2001
Analyst II
Performed routine wet chemical analysis on a variety of government and private
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industry environmental samples
Lead analyst of small team in Wet Chem department duties included
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scheduling, data analysis and review, training, heading up audits
Employed wide variety of analytical techniques, including IR, UV, TOC, FIA
•
Performed method development on high-throughput, automated wet chemistry
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instrument
BASF, Research Triangle Park, NC May 1999 to May 2000
Research Assistant
Prepared crop and soil samples for analysis in GLP compliant facility
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Maintained sample inventory & tracking database
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Coordinated sample delivery with customers
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EDUCATION
North Carolina State University May 2010 (expected)
Master of Science, Chemical Engineering
University of Cincinnati May 1999
Bachelor of Science, Biology
.
RECENT AWARDS
GSK EXCELLENCE Awards:
1. Project Delivery-Facilitation of successful NDA/MAA filing, March 2008
2. Quality- Enabling departmental quality through outstanding self-
inspections, January 2008
3. Project Delivery- Aided successful method validation and transfer under
pressure, May 2007
4. Project Delivery- Facilitation of successful NDA/MAA filing, October
2007
5. Laboratory Safety-Diligent, proactive and independent actions for insuring
departmental safety, March, 2007
6. Project Delivery –Exceptional performance during method transfer under
tight timelines, March 2007
Contact this candidate