DAVID JOHNSON

***** *** ***** **, **** #***, Broomfield, CO 80020 C: 1-816-***-**** acgqqu@r.postjobfree.com

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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