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Project Manager Customer Service

Location:
Hillsborough, NC, 27278
Posted:
March 09, 2010

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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),

compression, coating, and filling operations

Performed powder characterization methods including Flodex, bulk & tap

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,

polarized light microscopy methods; both automated and manual techniques

Adept technician on HPLC, UV, FLD, ASRS, TPW, Multidose, microscopy

equipment, including validation, troubleshooting, and proper maintenance

Engaged as lead user on updates, changes, and challenges with the electronic

laboratory notebook system (Electronic Experiment).

Led and participated in audits, then reported findings to senior leadership as

auditor for GMP self-inspection team

Served as department safety representative; point of contact for department on

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

Performed Cascade Impaction testing on Metered Dose Powdered Inhalers

Performed content uniformity, assay and impurity analysis on variety of solid

dosages, utilizing automated TPWII robotics, UV, HPLC, and GC analyses

Reviewed laboratory notebooks for accuracy, completeness, and compliance

Member of self auditing safety review team

Hired permanently after 6 month contract to hire term (May 2002)

Compuchem, Cary, NC May 2000 to September 2001

Analyst II

Performed routine wet chemical analysis on a variety of government and private

industry environmental samples

Lead analyst of small team in Wet Chem department duties included

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

instrument

BASF, Research Triangle Park, NC May 1999 to May 2000

Research Assistant

Prepared crop and soil samples for analysis in GLP compliant facility

Maintained sample inventory & tracking database

Coordinated sample delivery with customers

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



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