Doug D. Schmidt

*** ****** **.

Morganton, NC ***55

336-***-****

acd9w7@r.postjobfree.com

Education

• Clemson University, Clemson, SC 1999-2003 BS Degree in Microbiology

Cumulative G.P.A. of 3.2/4.0

Work Experience

Exela Pharma Sciences (Morganton, NC) – R&D / Contract Pharmaceutical Manufacturer

Senior Manager of Quality Control (Feb. 2013 – present)

• Oversight of Quality Control Chemistry Laboratory (i.e., review and approval of method protocols)

• Functional lead for rproduction in conjunction with Operations Team Leads and Senior Manager of QA

• Continued management of the Microbiology Laboratory

Manager of Microbiology (Feb. 2009 – Feb. 2013)

• Write and Implement Standard Operating Procedures according to cGMP and cGLP.

• Develop and validate new test methods for raw material, in-process, and finished product samples (Sterility, Bioburden and Indicator Organisms, Endotoxin, AET, etc. per USP)

• Establish and implement Environmental Monitoring Program (air, compressed gases, water, surfaces, personnel) per USP, EP, ISO, and PDA guidelines.

• Develop and perform Disinfectant Effectiveness Studies

• Develop and implement cleaning and sterile gowning procedures with the Operations Department

• Internal auditing and handling of external audits by customers and FDA during departmental review

• Develop and maintain cryo-stored cell line including in house identified isolates

• Purchase equipment and materials

• Hire and train staff

• Assist with autoclave and depyrogentaion oven validations

• Assist with design and performance of Media Fills

Pfizer, Inc. / Capsugel – Licaps (Greenwood, SC) Hard Gelatin Capsule Manufacturer

Microbiologist (November 2005 – August 2008)

• Perform raw material, in-process, and finished product testing

• Prepare and sterilize media and supplies

• Collect and process environmental monitoring samples

• Perform microbial identifications

• Perform equipment verifications and write and execute validation protocols

• Identify root cause of Out of Specification results and determine corrective actions through Deviation Investigations

Qualicaps (Whitsett, NC)

Chemist (November 2003 – November 2005)

• Perform raw material, in-process, and finished product testing for release and stability program following USP, EP, and JP guidelines utilizing GC, HPLC, IR, MS, refractometer, etc.

• Assisted in microbiology laboratory in sample collection and processing

LabCorp (Burlington, NC)

Toxicology Technician (May 2003 – November 2003)

• Performed testing to determine the presence of biochemical metabolite markers in babies to diagnose birth defects using HPLC.

• Performed testing to determine the presence of opiates in blood samples using MS/GC

Other Training, Certifications, Awards

• Method 1 Certified

• Six Sigma Green Belt

• USP Harmonization Workshop (May 2007)

• ASM Laboratory Management and Leadership Workshop ( May 2007, June 2008)

• B.E.S.T Microbiology Training Seminar (March 2013)

• Proficient in Mircrosoft Access, Word, Excel, Powerpoint, etc.

• Eagle Scout

Contact this candidate