Biological Manufacturing Assistant
Resume:
Nicole Nelson ** Sugar Mountain Rd, Hamilton, MT *9840
406-***-**** **************@*******.***
SUMMARY OF QUALIFICATIONS
Contains a Bachelor of Arts degree in Forensic Anthropology with 3 years of experience in the purification process of an Active Pharmaceutical Ingredient (API) in a cGMP manufacturing setting. Highly organized, dependable, detail-oriented, excellent leadership skills. Demonstrated ability to work successfully both independently and in a team setting. Excellent oral and written communication skills.
• Proficiencies: High Performance Liquid Chromatography (HPLC - Ion-exchange, large and small scale); Liquid-Liquid Phase Separation; Tangential Flow Chromatography (TFC); Acid/Base Hydrolysis reactions, Autoclave, Lancer/washer, and Dry Heat Depyrogenation .
• Aptitude for working in a cGMP regulated setting to ensure ethical and compliant data in the manufacturing work environment.
• Excellent working knowledge of cGMP policies, guidelines, regulations, and Standard Operating Procedures (SOPs).
Professional Experience
GLAXOSMITHKLINE BIOLOGICALS (GSK), Hamilton, MT 2007-2010
High-Potential Biological Manufacturing Professional
Purified and manufactured API in the GSK Production Department.
• Responsible for purification of cellular extracts through organic extraction, hydrolyses, liquid-liquid phase separation and ion-exchange chromatography to achieve a purified API ready for formulation.
• Prepared material and equipment for Production procedures according to cGMP regulations.
• Supported proper cGMP guidelines for the cleaning of equipment and facilities.
• Investigated and completed documentation for SOPs, Deviation Reports, Corrective Action / Preventive Action Reports, and Site Modification Requests required throughout the purification process to ensure ethical and compliant manufacturing of API.
• Made daily updates to the status of the API Production Schedule at the Hamilton, MT site as reference for the site employees and GSK worldwide
THE COFFEE CUP CAFÉ, Hamilton, MT 1998-2007
Waitress
Ensure all required duties are performed successfully throughout shift.
• Performed job duties such as hostess, waiting tables, preparing food, training new hires, various customer service and managerial responsibilities.
• Food was always prepared and delivered in a timely manner.
• Responsible for end-of-shift activities and proper lock-up procedures of the building at closing.
• Duties were sometimes performed under pressure and always performed with a positive attitude.
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65 Sugar Mountain Rd, Hamilton, MT 59840
406-***-**** **************@*******.***
Professional Development
Technical Development Courses/ Seminars:
• Good Manufacturing Practices (cGMP) training, GSK Biologicals, Annually
Education
BA, Anthropology with concentration in Forensics, University of Montana, Missoula, MT, 2007
References
• Keintz, Lindsay M., ReSearch Pharmaceutical Services
2206 Meadow Dr. Blue Bell, PA 19422
• Patzer, Cheryl, Owner of Coffee Cup Café
500 S. 1st St. Hamilton, MT 59840
• Skelton, Randy, Anthropology Professor; University of Montana
2348 W Kent Av, Missoula, MT
Contact this candidate