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Continuous Improvement Manufacturing

Location:
Durham, NC
Posted:
December 02, 2016

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Resume:

Sean A. Thompson

Durham, NC *****

269-***-****

acxqgq@r.postjobfree.com

Education

Lean Six Sigma Green Belt, Wake Technical Community College; Raleigh, NC

M.S. Biological Sciences, Western Michigan University; Kalamazoo, MI

B.S. Biology, Oakwood University; Huntsville, AL

Knowledge, Skills, and Interests

■Mammalian cell culture.

■High-throughput screening.

■Biomanufacturing.

■Alternatives to animal testing.

■Molecular biology.

■Environmental monitoring.

■Operational systems.

■Laboratory automation.

■Commissioning, qualification, and validation.

■Continuous improvement.

■Mentoring and team building.

■Good Laboratory Practices (GLP).

■Good Manufacturing Practices(GMP).

■Immunocytochemistry.

■Microscopy.

■Clean room gowning.

■Aseptic operations.

Publications and Published Abstracts

Thompson, S.A., et al. 2006. ACh neuroprotection against glutamate-induced excitotoxicity in adult pig RGCs is partially mediated through alpha4 nAChRs. Exp. Eye Res. 83 (5): 1135-1145.

Wehrwein, E., S.A. Thompson, et al. 2004. Acetylcholine protects isolated pig retinal ganglion cells from glutamate-induced excitotoxicity. IOVS. 45(5): 1531-1543

Thompson S and C.L. Linn, 2004. Multiple nAChR subunits are involved in ACh neuroprotection of pig retinal ganglion cells. Michigan Chapter Society for Neuroscience Annual Meeting.

Thompson, S and C.L. Linn. 2003. Multiple nAChR subunits are involved in ACh neuroprotection of pig retinal ganglion cells. Soc. Neurosci. Abst. 29. 264.15

Smith, O.J., S. Thompson and C.L. Linn, 2003. Alpha 7, alpha 4 and beta 2 nicotinic acetylcholine receptor subunits are involved in ACh neuroprotection against glutamate-induced excitotoxicity. ABRCMS San Diego, CA

Wehrwein, E., S. Thompson, D.M. Linn, and C.L. Linn. 2002. Neuroprotective effects of acetylcholine on pig retinal ganglion cells are mediated through nicotinic receptors. Soc. Neurosci. Abst. 28, 36.9.

Experience

06/2013-Present: Manufacturing Associate III, Argos Therapeutics; Durham, NC

■Upstream and downstream aseptic cellular processing.

■Developing and revising standard operating procedures.

■Generating User Requirement Specification documents.

■Initiating and presenting change controls for process improvements.

■Raw materials and consumables risk assessment for FDA compliance.

■Batch record review to support process validation.

■Performing periodic reviews to assess system validation compliance.

■Subject matter expert for environmental monitoring system.

■Executing protocols for manufacturing of immunotherapies.

■Tech transfer from process development to manufacturing.

■Aseptic Process Validation to ensure sterility of manufacturing processes.

■Training of personnel on process procedures for efficient execution.

■Executing system validation protocols for instrumentation (IOPQ).

■Activities and Outreach Committee.

■Environmental Health and Safety Committee.

2010-Present: Consultant

■Aseptic techniques.

■Microscopy and imaging.

■GLP/GMP requirements.

■Alternatives to animal testing.

■Laboratory design.

■Process improvement and development.

11/2009-8/2010: QC Associate Scientist, Emergent Biosolutions; Lansing, MI

■Select agent qualified.

■Disinfectant efficacy studies for new vaccine production facility.

■Revising developmental, qualification, and validation protocols.

■Providing scientific and technical support on assay validation methods.

■Scale down of manufacturing processes to support product testing.

■Writing and presenting change controls.

■Cell culture optimization for testing of finished product.

■New equipment implementation.

■Assessing the compliance status of test methods and equipment.

■Training and mentoring laboratory personnel.

12/2008-11/2009: Lead Cell Culture Scientist, CeeTox Inc.; Kalamazoo, MI

Included with my responsibilities as Cell Culture Scientist:

■Managing and maintaining the integrity of the cell culture facility.

■Working with management to meet project specific cell culture requirements.

■Scheduling the use of cell culture facilities.

■Developing and revising standard operating procedures.

■Writing and presenting IACUC protocols.

■Bone cell transformation.

■Skin sensitization.

■Transitioned cell culture facility to GLP compliance.

■Training and mentoring personnel.

11/2005-12/2008: Cell Culture Scientist, CeeTox Inc.; Kalamazoo, MI

■Maintaining the integrity of the cell culture facility.

■Ensuring supplies were adequately stocked.

■Improved laboratory design to ensure safety of personnel.

■Communicating the company’s requirements to suppliers.

■Microscopy and live cell imaging.

■Developed cellular platform for cardiotoxicity testing.

■Cell culture process optimization for toxicity testing platforms.

■Routine harvest and maintenance of primary cells and cell lines.

■Metabolic activation assay optimization.

■Performing plate based assays to assess In vitro toxicity.

■High throughput toxicity screening of client compounds.

■Electronic and manual data management.

■Maintenance of laboratory equipment and instrumentation.

■Small animal handling.

■Cell banking.



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