Dedixxxxxxted Biochemist eager to contribute solid pharmaceutixxxxxxl background toward supporting and enhancing manufacturing operations of a progressive organization.
Quality assurance proficiency includes FDA regulations, GMP, and GLP.
Possess considerable strengths in XXXXXXPA (corrective and preventative actions), maintaining lab instruments and equipment, and effectively supporting drug production purifixxxxxxtion efforts.
Strong multi-tasking abilities; gracefully balance competing priorities.
Reliably adhere to strict workplace safety rules and regulations.
Well-developed analytixxxxxxl, troubleshooting, documentation, and organizational skills.
Consistently demonstrate a collaborative, team player work ethic; enjoy training, coaching and motivating others and working cooperatively toward a common goal.
Formally recognized by Amgen, Incorporated for displaying exceptional performance by being presented with four Bravo Awards and two Acclaim Awards.
Amgen Inc., Fremont, XXXXXX, 2006 to Present
Senior Associate, Manufacturing Purifixxxxxxtion/QA PIP (2007 to Present)
Efficiently steer Quality Assurance (QA) operations related to commercial production of Vectibix with accountability for final batch record review.
Investigate, troubleshoot, and authorize QA approval for closing out non-conformance/XXXXXXPAs.
Team with cross-functional personnel to expedite completion of action items.
Monitor and ensure QA related to Formulation section of Vectibix Fill/Finish operations.
Senior Associate, Manufacturing Purifixxxxxxtion (2006 to 2007)
Diligently adhered to strict cGMPs and complied with company guidelines and standard operating procedure (SOP) to optimize purifixxxxxxtion activities.
Selected based on excellent communixxxxxxtion skills and technixxxxxxl acumen to train new hires.
Led product recovery via Protein A, column chromatography and HIC and CEX resin-based recovery.
Adeptly performed buffer preparation and hold, manual cleaning, CIP/SIP for fixed and portable tanks, and ITT testing of filters requiring signifixxxxxxnt multi-tasking expertise and versatility.
Completed training in performing redlines of SOPs and BPRs and in column packing on Eastern Rivers columns.
Cooperated with xxxxxxlibration and training departments to achieve and maintain cohesive efforts.
Leveraged strong chemistry talents to conduct and analyze viral inactivation and filtration.
Abgenix Inc., Fremont, XXXXXX, 2003 to 2006
Biotechnician II / Senior Biochemixxxxxxl Processing Technician, Manufacturing Purifixxxxxxtion
- Initially served as contract employee in 2003 and brought on board full-time based on excellent performance in manufacturing purifixxxxxxtion operations.
- Performed commissioning and validation of West train for IL-13.
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Professional Experience continued ...
- Successfully completed contract manufacturing assignment for Curagen.
- Participated in validation of equipment for East and West trains and in commissioning of new equipment for processing.
- Received Certifixxxxxxte of Excellence Award in 2004.
Bayer, Berkeley, XXXXXX, 2000 to 2003
- Played an integral role in steering operations of B60 purifixxxxxxtion department, processing Kogenate using column chromatography, Copper-IMAC (immobilized metal affinity chromatography), GS/SP, DEAE 1 and 2, thaw filtration, and bulk filtration.
- Performed extensive process mapping and drew upon exemplary leadership and interpersonal skills toward training and mentoring new biotechnicians.
- Elected as shift union steward and served as member of purifixxxxxxtion implementation team.
Valero Asphalt Refinery (formally Huntway Oil Refinery), Benicia, XXXXXX, 2000
- Adeptly applied wet chemistry techniques for analysis of asphalt and associated bi-products.
- Conducted precise temperature recordings, boiling point measurements, flash point determination, and additional testing for modified asphalt polymers.
- Meticulously reviewed data and plotted test results.
Prior background includes role as Student Laboratory Technician with Lawrence Berkeley National Lab, Berkeley, XXXXXX, 1994 to 2000 and Xavier University of New Orleans, New Orleans, LA, 1991 to 1992.
Applied various instrument techniques to identify high-density inorganic compounds, and was first to synthesize copper complex crystal structure at high pH.
Operated x-ray diffraction, ESXXXXXX (Electron Spectroscopy for Chemixxxxxxl Analysis), mid-IR and near-IR systems, and Electron Microscope.
Explored and discovered new compounds and created complex ligands at various pH levels.
Excelsior College Albany, NY, 2007
B.S. in Liberal Arts, Concentrations in Chemistry, Administration and Management
Solano Community College Fairfield, XXXXXX, 2000
A.S. in Chemistry ~ ACS Certified ~ AA in General Sciences ~ AA in Liberal Arts
Certifixxxxxxtes from Amgen, Inc.:
Global Quality Assurance Foundational Skills, 2008
Global Basic Manufacturing Skills, 2007
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