Gregory J. Robinson

**** ********* ** *: 585-***-**** C:

585-***-****

Stafford, New York 14143

Email abmuio@r.postjobfree.com

PROFESSIONAL SUMMARY

Diligent, detail-oriented Scientist and Medical Writer with over ten years

of experience in Research and Development performing technical report

writing, experimental testing, and data analysis. Keen technical skills in

conjunction with an innate ability to communicate and collaborate with

others provides for the ability to function well in either a team setting

or on an individual basis. Process improvement and technical writing a

specialty.

Business Environments: Pharmaceutical industry, Healthcare

Proven Expertise:

. Technical writing

. Troubleshooting

. Process Data

. Compliance Verification

. Study Reports

. Coordinate

. Supervision/Leadership

. Data Analysis

. Test Design and Execution

PROFESSIONAL EXPERIENCE

DUCK FLATS Pharma, LLC, Elbridge, NY

2010 - 2012

Sr. Scientist/Medical Writer

Provide medical-based text assimilated from nonclinical and clinical study

reports into summaries within NDA Section Modules 2.4, 2.6, 2.5 and 2.7

slated for FDA submission. Process information gleaned from drug

historical data and study reports and incorporate this information into

medical-based text in support of Briefing Document, NDA Sections 2.6, 2.4,

and 2.7, and White Paper submission. Review articles related to proposed

drug submission that support drug pharmacology, safety, efficacy,

pharmacokinetics, and toxicology. Prepare study protocols, study reports,

TLFs and Errata.

. Provide nonclinical NDA Sections 2.6 and 2.4, and clinical NDA Section

2.7 summaries for a diagnostic PET imaging agent.

. Process nonclinical and clinical information of an existing pressor agent

for medical-based text in support of FDA Briefing Document and NDA

Sections 2.6 and 2.4.

. Prepare nonclinical Briefing Document and NDA Sections 2.6 and 2.4

summaries of an existing pressor agent.

. Review clinical study reports and document evidence for the strategic

rationale in the White Paper submission on transdermal drug delivery.

. Prioritize workload according to deadlines and discuss adjustments to

maintain quality and improve turnaround time.

Ortho-Clinical Diagnostics, Rochester, NY

2005 - 2010

Scientist I

Assured compliance with FDA guidelines and regulations. Prepared

reports/papers on experimental testing and data analysis in cross-

functional teams to achieve company strategies. Provided support for

existing assays and products, new technology, and assay development.

Contributed to NPC, Clinical, Regulatory, Manufacturing, and Market Dev /

EBM strategies. Performed maintenance and validation activities (IQ, OQ,

PQ) on analyzers. Conducted in-house safety inspections. Performed HBsAg

and anti-HBs assay troubleshooting. Carried out OAS (on analyzer

stability) testing for various assays.

. Prepared reports on experimental testing and data analysis for new

technology activities, 4,3

Gregory J. Robinson

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PROFESSIONAL EXPERIENCE (con't)

feasibility testing, system integration, 5600 and 3600

verification/validation, cancer ELISAs, Troponin I Ultra, Galectin-3, and

Free/Total PSA assays.

. Tested and evaluated the impact proposed changes have for the 5600/3600

systems and documented the impact proposed changes have on HBsAg ES

assay.

. Facilitated work on 5600/3600 analyzers from product concept to product

launch.

Wyeth, Rochester, NY

1998 - 2004

Research Scientist II

Supported Discovery (Preclinical), Manufacturing, and Clinical functions.

Prepared and implemented SOPs and other internal documentation in

compliance with FDA and GMP guidelines. Executed validation and

qualification documents (IQ, OQ, PQ) on laboratory equipment. Worked with

vendors to purchase more efficient equipment and assay components.

Coordinated lab functions and responsibilities. Conducted and attended

safety seminars and inspections.

. Developed, validated, qualified and performed Pre-clinical ELISAs and

bioassays in support of, and resulting in the release of Hib-titer,

Meningitec, and Prevnar vaccines.

. Led Pre-clinical support of group B streptococcus and N. meningococcus

programs.

. Elevated the Pre-clinical function to GMP status.

. Executed validation and qualification documents (IQ, OQ, PQ) on

laboratory equipment.

ACM Medical Laboratory, Inc., Rochester, NY

1994 - 1999

Specimen Processing Technician (1998- 1999)

Maintained specimen integrity from accurate data entry to proper

processing, which includes centrifugation, aliquoting, cell cultures, gram

stains, cell washing, pH determination and adjustment, positive blood

culture set-up, and sample automation maintenance and problem solving.

Supported customer service directly and indirectly through primary draw

sites. Coordinated shipment of outsourced testing.

Office Assistant, Med-Scribe (1998)

Converted and updated medical files and ECGs for cardiology practice.

Answered phones and inquiries in lieu of MD's absence.

Specimen Processing Supervisor (1996 - 1997)

Supervised function of department and 15+ employees in coordination with

Hematology, Chemistry, Serology, Microbiology, and Toxicology departments.

Prepared and provided SOPs for employees regarding job function, GLP, and

safety. Developed SOPs to decrease customer turnaround time while adding

new draw sites and secondary customers. Developed SOPs to maintain GLP and

safety standards. Performed routine functions of laboratory technician.

EDUCATION

St. Bonaventure University, Olean, NY

Bachelor of Science, Biology

Gregory J. Robinson

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PROFESSIONAL TRAINING

. Six Sigma/Process Excellence

. AACC Seminars

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