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Scientist Ii Quality Control

Location:
Woodstock, IL
Salary:
80000
Posted:
February 02, 2024

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Resume:

Christopher Danielson

**** ******* ** *********, ** 60098

E-mail: ad3bi8@r.postjobfree.com

Education:

B.S. Chemistry

Western Illinois University, Macomb IL

Minor: Physics

Graduation Date: May 2004

Work Experience Related Skills:

HPLC cGMP Documentation UV/VIS Graphite Furnace AA

GC/FID Visual/Potentiometric Titration Karl Fischer Titration

Flame AA Brookfield Viscometers Kinematic Viscosity

Polarimetery TOC ICP-MS

Work Experience:

June 2019 to October 2023 Beckton Dickinson

Scientist II

Responsibilities include:

Review, and execution of Analytical Method Verification and Validation Protocols. Lab testing in support of feasibility, stability, verification and validation studies. Completed and reviewed cGMP Documentation of laboratory results per FDA regulations. Documentation of instrument calibration. Administration of spectrometer software.

March 2018 to June 2019 SSI Contracted to BD

Scientist II

Responsibilities include:

Review, and execution of Analytical Method Verification and Validation Protocols. Lab testing in support of feasibility, stability, verification and validation studies. Completed and reviewed cGMP Documentation of laboratory results per FDA regulations.

August 2016 to February 2018 Medifil INC

Senior Analytical Chemist

Responsibilities include:

Drafting, execution, and approval of Analytical Method Verification and Validation Protocols and Material Specifications. Lab testing in support of feasibility, stability, verification and validation studies. Completed and reviewed cGMP Documentation of laboratory results per FDA regulations.

February 2016 to June 2016 Contracted to Abbvie Pharmaceuticals

Chemist II

Responsibilities included:

Lab testing of Development, Clinical supply and stability samples per SOP using various methods including HPLC, UV/VIS, Various Dissolution methods and Potentiometric titrations for Identification Assay and Impurities determination. Completed and reviewed cGMP Documentation of laboratory results per FDA regulations.

February 2014 to November 2015 Fresenius-Kabi

Chemist

Responsibilities included:

Lab testing of production and stability Injectable samples per SOP including Anti-neoplastic and Beta-Lactam drugs using various methods including HPLC, UV/VIS, and Potentiometric titrations for Identification Assay and Impurities determination. Completed and reviewed cGMP Documentation of laboratory results per FDA regulations.

August 2013 to February 2014 contracted to Fresenius-Kabi

Chemist

Responsibilities included:

Lab testing of production and stability Injectable samples per SOP including Anti-neoplastic and Beta-Lactam drugs using various methods including HPLC, UV/VIS, and Potentiometric titrations for Identification Assay and Impurities determination. Completed cGMP Documentation per FDA regulations and performed OOS Result investigation and retest confirmation.

June 2012 to July 2013 contracted to Now Foods.

Chemist

Responsibilities included:

Lab testing of production Tablet, Capsule, and Soft-Gel samples per SOP using various methods including HPLC, UV/VIS, and Potentiometric titrations for Potency Determination. cGMP Documentation including OOS Result investigation and retest confirmation. Member of the Lab Safety Subcommittee, responsible for authoring, reviewing and implementing new safety procedures.

May 2010 to May 2012 Catalent Pharma Solutions.

Chemist Quality Control

Responsibilities included:

Lab testing of production Inhalation and Ophthalmic samples per SOP using various methods including HPLC, UV/VIS, and Visual/ Potentiometric titrations. Maintenance of the Anatel In-Line TOC/Conductivity sensors. Executing method transfer and development protocols for new product development. cGMP Documentation per FDA regulations including OOS Result investigation and retest confirmation and writing scientific summary reports.

June 2008 to May 2010 contracted to Catalent Pharma Solutions

Chemist Quality Control

Responsibilities included:

Lab testing of production samples per SOP using various methods including HPLC, UV/VIS, and Visual/ Potentiometric titrations. Maintenance of the Anatel In-Line TOC/Conductivity sensors. Executing method transfer and development protocols for new product development. cGMP Documentation and writing scientific summary reports per FDA regulations.

August 2007 to June 2008 contracted to Baxter Healthcare.

Researcher I Revalidation Group

Responsibilities included:

Lab testing for SOP method validation for USP compliance samples using various methods including HPLC, UV/VIS, Flame AA, and Visual/ Potentiometric titrations. cGMP Documentation per FDA regulations and writing Validation protocols, and scientific reports.

December 2004 to August 2006

Assistant Chemist Marketed Product and Plant Support Hospira Inc.

Responsibilities included:

Lab testing per SOP of stability and method validation samples and testing of raw materials for feasibility and development using various methods including HPLC, UV/VIS, Graphite Furnace AA, Flame AA, GC/Headspace GC, Karl Fischer and Visual/ Potentiometric titrations. Providing training for Graphite Furnace and Flame AA. cGMP Documentation per FDA regulations including writing and verifying scientific reports and reviewing and updating SOPs.

May 2004 to November 2004 Contracted to Hospira Inc.

Assistant Chemist Marketed Product Plant support. Responsibilities included Lab testing per SOP of stability and method validation samples and testing of raw materials for feasibility and development using various methods including HPLC, UV/VIS, Graphite Furnace AA, Flame AA, GC/Headspace GC, Karl Fischer and Visual/ Potentiometric titrations.

Fall semester 2003 Lab Teaching Assistant general inorganic chemistry Western Illinois University. Responsibilities included Set-up and demonstration of experimental equipment, preparation of solutions, supervision of 20 students, evaluation and recording of grades, in lab instruction and troubleshooting.

Summer 2002 Lab inventory Western Illinois University.

Responsibilities included organization and inventory of chemicals in stockrooms, organization and cleaning of stockrooms and lab areas, collection of chemical wastes for safe disposal, cleaning and maintenance of lab equipment.

Fall 2000 - spring 2002 Lab and demonstration prep assistant.

for local outreach program. Responsibilities included preparation of solutions and equipment, performance of demonstrations, assistance in instruction of chemistry and physics labs for elementary and middle school students, testing of new demonstrations and modification of existing demonstrations, safe disposal of chemical wastes.

Summer 2000, 2001 General machine shop work BTM Industries.

Operated Milling machines and CNC controlled presses.

References available upon request.



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