HANS STAAB
*** **** ***** ****** #**, Nederland, Colorado 80466
*******@*******.***
QUALITY CONTROL CHEMIST
QUALIFICATIONS PROFILE
Remarkably astute, highly motivated, and dedicated quality control chemist; offering more than 15 years of broad-based and hands-on experience in the pharmaceutical industry, including engagement in several validation processes.
Areas of Expertise
Research and Data Analysis
Cell Cultures and Propagation
Laboratory Procedures
Problem Resolution
Analytical Sample Preparation
Regulatory Compliance
Technical Writing and Documentation
Laboratory Equipment Maintenance
Powered with excellent leadership skills coupled with strong educational foundation. Expert at writing comprehensive reports and protocols for new instrumentation as well as in characterization and synthesis of various organic and pharmaceutical compounds. Passionate in learning new testing processes and sharing knowledge to other individuals. Recognized for strong work ethic backed with the ability to formulate plans that lead to the improvement and achievement of goals. Adept at implementing new concepts, methods, and technologies; as well as in facing challenges while maintaining composure. Extremely capable of handling tasks simultaneously in high-stress and fast-paced environments.
EDUCATION AND CREDENTIALS
BACHELOR OF SCIENCE IN CHEMISTRY AND MEDICAL TECHNOLOGY, MINOR IN MICROBIOLOGY, 1995
Avila University, Kansas City, MO
Graduated magna cum laude | GPA 3.9
COURSEWORK IN BIOLOGY, MINOR IN CHEMISTRY, 1990
John Brown University, Siloam Springs, AR
Certified Clinical Laboratory Scientist, 1995
Certification from American Society for Clinical Pathology, 1995
PROFESSIONAL EXPERIENCE
ADVANCED QUALITY CONTROL CHEMIST - Agilent Technologies, Inc. Oligonucleotide Division, Boulder, CO - 2008–Present
- Efficiently execute in-process testing for every batch analytical records (BARs) and specific standard operational procedure (SOP) or methods regarding crude samples of oligonucleotides.
- Exemplified extensive knowledge in performing stability test on previously manufactured active pharmaceutical ingredients in accordance with specified client protocols, which include moisture testing by automated Karl Fischer titration, purity testing by high-pressure liquid chromatography, and pH testing of sample solution.
- Hold full accountability for continuous maintenance and troubleshooting of Karl Fischer instruments.
- Apply well-honed skills in testing raw materials for identity, purity, and content by utilizing the following techniques:
- Nuclear magnetic resonance (NMR) for purity
- Gas chromatography (GC) for residual solvents
- Liquid chromatography/mass spectroscopy (LC/MS) for molecular weight
- Fourier transform infrared spectroscopy (FTIR) for identity and moisture per Karl Fischer titration
- Carefully deliver new instruments to be used in the laboratory and transcribe new instrument installation qualification, operational qualification, and performance qualification protocols.
- Create comprehensive reports for installed qualified new instruments and SOPs for new instruments.
- Share knowledge to new analyst and facilitate training of team members regarding new instruments.
- Meticulously examine analytical testing conducted by quality control chemists and ensure preventative maintenance on instruments, preparation of testing solutions, and analysis of acquired data and reporting of results.
Key Highlights:
- Functioned as point person for laboratory testing during the very first consistency lots for validation of an active pharmaceutical ingredient.
- Played a pivotal role in writing methods for protocol testing concerning the validation process as well as continued in-process testing of the product.
- Systematically organized the schedule for testing crude material within the three-month period, which was significant in making the company marketable to pharmaceutical companies.
QUALITY CONTROL CHEMIST - Sanofi-Aventis Pharmaceuticals, Inc. Kansas City, MO - 1999–2007
- Ensured product potency, purity, safety, and stability by performing finished product testing on Allegra, Ketek, Altace, and Cardizem.
- Proficiently instigated testing protocols and instrumentation which included assay and content uniformity by high-performance liquid chromatography (HPLC), UV-spectroscopy, or FTIR-spectroscopy.
- Structured laboratory workflow, acquired and evaluated data, and entered results into the laboratory information management system (LIMS) system.
- Demonstrated expertise by conducting testing of applications and solutions, performing instrument calibrations, and maintaining operational qualifications of new instrument in the laboratory area.
- Facilitated the training of fellow analysts in using new instruments.
Key Highlights:
- Authored necessary document to benchmark IQ/OQ process for quality control laboratory in compliance with Code of Federal Regulations/Title 21/Part 11 (regarding requirements for electronic records and signatures).
- Effectively utilized ingenuity and perseverance in repairing non-functioning equipment (Karl Fischer Titrator printer), leading to the prevention of unbudgeted expenditure for replacement printer.
PRODUCTION VIROLOGIST - Bayer Animal Health, Shawnee Kansas - 1996–1999
- Managed and administered the production of tissue cultures and cell lines required for virus infection and eventual vaccine production.
- Successfully structured filter housings, acquired samples of liquid cultures from bacterin manufacturers, and conducted experiments on different filters to identify their usefulness.
- Productively generated larger batches of bacterin by utilizing centrifuges, automated diafiltration instruments, and sterilization.
- Assumed accountability in preparing and sterilizing laboratory equipment, guaranteed compliance with all written procedures, and maintained comprehensive documentation of all work done.
- Provided virologist with sufficient cells to infect for vaccine production by culturing dog kidney cells from frozen stage and sustaining continuous propagation.
- Enhanced production quality of Hyaluronic Acid used as a treatment for joint movement in horses by conducting extensive testing.
Key Highlight:
- Singlehandedly executed trial experiments regarding the procedure for precipitating Hyaluronic Acid, which was later used in increasing production and which enabled the production biologists to perform precipitation step only once.
TECHNICAL SKILLS
Test Equipment: Software:
- Unicam UV4 Spectrometer
- Agilent Single Quadrupole LC/MS
- Agilent 1100/1200 with and Waters Series HPLC systems
- Perkin Elmer 200 series
- Thermo Nicolet Nexus 470 Fourier Transform Infrared Spectrophotometer
- Waters LC Equipment/Software
- Mettler Toledo Karl Fischer Titration V30 and C30 using LabX software
- Metrohm 785, 716, 851 coupled with 874 oven processer
- HPLC Detectors: Diode-array Detector and Refractive Index
- Karl Fischer Coulometer 737
- pH Meter Usage - PC and Apple/Macintosh OS
- Panther
- Windows NT
- Microsoft Office Suite (Word and Excel)
- WordPerfect
- Laboratory Data Acquisition Systems
- Citrix
- LIMS
- Chemstation Software
- Tiamo Software by Metrohm
- Empower HPLC Acquisition
ACTIVITIES AND AFFILIATIONS
American Chemical Society
American Heart Association for Heart Saver First Aid Program
Chemical Emergency Response Team (CERT)