Manufacturing Years Experience
Resume:
DAVID JOHNSON
***** *** ***** **, **** #***, Broomfield, CO 80020 C: 1-816-***-**** *************@*****.***
PROFESSIONAL OVERVIEW
Pharmaceutical research and development Scientist with five years experience i n support of
new molecule drugs and formulations. Focus on development and scale up of
pharmaceuticals with concentration in design/optimization of analytical methods, subject
research, and authoring protocols/reports. Three years experience in vaccine manufacturing
consisting of new product transfers and bulk formulation.
SUMMARY OF SKILLS
Chromatography Method Validation
Bulk Manufacturing Formulation Troubleshooting
Analytical/Formulation Creating Batch Records
Research
EDUCATION
Bachelor of Arts: Biochemistry
2005
Wichita State University - W ichita, K S
PROFESSIONAL EXPERIENCE
Scientist, Analytical Chemistry
09/2005 to 09/2010
Boehringer Ingelheim
Operated and trained laboratory employees on HPLC / UPLC, GC, UV-VIS
spectrometry, dissolution, and physical testing equipment.
Supported pre-formulation, process validation, batch release, formulation stability,
and special request testing for clinical trials and manufacturing transfer .
Authored protocols and final reports to facilitate validation of analytical
m ethods and stability studies.
Developed quality analytical methods with regard to transfer department to
reduce overhead and increase throughput.
Performed chemical and physical tests as necessary following EU / USP
Pharmacopoeias.
Established a reputation as the go -to person for HPLC software troubleshooting
and non-routine procedures.
Encouraged, evaluated, and integrated new technologies into the workplace.
Researched compounds/analytics as needed and compiled data to create
presentations, plans, or reports.
Maintained research and documentation practices in compliance with
cGMP, FDA, and EU regulatory guidelines.
Provided expertise in administration and customization of instrument
software resulting in streamlined process analysis.
Peer review of analytical notebooks
Scientist II, Vaccine Manufacturing
09/2010 to 06/2014
Boehringer Ingelheim
Created and calculated pilot vaccine formulations to ensure regulatory
guidelines and potency.
Troubleshooted production performance issues such as potency and stability.
Concentration / purification of toxin and bacterium.
Wrote and reviewed SOP's, batch records, change controls, unusual occurrence
investigations, OOS's, Reprocessing requests, and other reports as
required.
Potency data trending using Microsoft Excel / JMP tables and graphs.
Supported transfer and implementation of new vaccine products into regulated
areas of production.
Collaborated with other departments to plan, schedule, and manufacture
vaccine bulks to meet deadlines and customer demand.
Oversaw and trained operators through manufacturing process.
CERTIFICATIONS
Practical Approach to GLP's, Debi Garvin, April 2006
Intermediate & Advanced HPLC: Techniques of Use, Care, Regulatory
Compliance & Method Development Utilizing DryLab 2000 Software Tools,
University of Kansas: August 2006
Current Good Manufacturing Practices That Can Impact the Pharmaceutical
Industry, University of Kansas: October 2006
HAZWOPER Emergency Response Team Environmental Certification, August
2006-2014
HPLC Summit/Ultimate 3000 HPLC Operation: Dionex: June 2007
Chromeleon Chromatography Software Management training, Dionex:
Levels 1-2 (June 2007), Level 3 & System Administrator Training (June 2008)
B iostatistics I & II, University of Kansas: April 2007
GMP Documentation in Pharmaceutical Small Molecules Laboratory Quality,
University of Kansas, September 2007
Sampling and Sample Preparation, March 2010
Modern HPLC for DMPK, Bioanalytical, and Analyti cal Development
Scientists, Feb 2010
Ultra - High - Pressure LC (UHPLC): Concepts, Practices, Issues, Alternatives
and How to get Started, Feb 2010
Engineering Statistics & Data Analysis using SAS JMP software v8.0, July 2010
Program Management, Feb - March 2011
Six Sigma Yellow Belt, 2014
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