Chemist/Project Manager

James Cox

***** ******* **. ***** *******, Ca. **351 ● 213-***-**** ● ***********@*****.***

Summary Of Qualifications

• Preformed analytical analysis of compounds and API using HPLC, Gas Chromatography (GC), UV, A.A., FTIR, TLC, and TOC.

• Success in recognizing results that deviate from established standards, and recommending appropriate actions. Perform testing necessary to investigate out-of-specification test results.

• Conducted method development, validation and transfers using USP and internal guidelines.

• Revised or created S.O.P.’s for implementation of analytical procedure in a cGMP, FDA and USP regulated laboratory environment.

• Experienced in composing/conducting out of specification (OOS) and investigation reports.

Education

BS Biochemistry MLT, California State University Northridge, Northridge, Ca 2006

Work History

Puretek, San Fernando, Ca.

Sept 2009 – Current

Chemical Analyst/QC Chemist

• Developed bioanalytical methods for quantitative and qualitative analysis of active pharmaceutical ingredients for use on G.C. and A.A. instrumentation.

• Creation and revision of SOP’s and validation of analytical methods for HPLC, Gas Chromatography and Atomic Absorption.

• HPLC, GC, UVA, AA and FTIR assay of raw materials.

• Supervision of lab techs laboratory procedures, documentation and notebook review.

• Conducts employee technical training.

PharmaForm LLC Austin, Tx.

Apr 2007-Jan 2008

Chemist 2

• Developed bioanalytical methods for quantitative and qualitative analysis of active pharmaceutical ingredients for use on HPLC instrumentation.

• Performed method validations and transfers for the R&D department and the QC department.

• Wrote and revised SOP’s and analytical procedures.

• Conducted data and statistical presentations to clients and superiors, with suggestions on improvements, time lines, and budget concerns.

• Conducted technical training of employees on all new methods, research techniques and laboratory equipment.

• Facilitated the rebuilding of the Method Development Division by running the division, interviewing potential candidates and management of employees, projects and day-to-day operations.

• Performed research on new drug development, related substances, potency, assay, delivery and determination of bioavailability. (HPLC, GCMS, FTIR and Atomic Absorption).

• Identified and solved scientific laboratory problems:

1. Identified and implemented strategy that solved TFA degradation.

2. Designed new policy for chemical and water purity that alleviated multiple testing complications in the research division, as well as, the Q.C. dept.

3. Determination of LOQ failure department wide and brought in the necessary equipment and policies to solve the problems and improve over all performance in research

Northridge Labs, Northridge, Ca.

Jan. 2007 – Mar 2007

Analytical Chemist,

• Conducted company wide training on new HPLC equipment and basic troubleshooting.

• Conducted HPLC and Thin Layer Chromatography analysis of final product and raw materials, as well as, basic creation of trial formulas for new clients.

• Performed dissolution and disintegration testing of current products, research studies and new project development.

Bachem, Torrance, Ca.

April 2006 – Jan 2007

Research Chemist,

• Conducted method development, validation, implementation and application of LC-MS bioanalytical methods for analytical analysis of A.P.I. and production chemistry.

• Developed, wrote and revised analytical and preparatory methods, as well as, SOP’s.

• R&D and cGMP Protein Synthesis.

• Preparation and presentation of data generated and production records to clients and senior staff.

• Developed methods for both preparatory and analytical HPLCs for Human Growth Hormone and Beta Four Thymosin. My contributions improved the yield for human Growth Hormone by 1.2 kilo. Out look for Beta Four Thymosin is 1 kilo increase in yield.

Henry County Fire Dept, Henry Co. Ga.

Fire Fighter 2 and EMT Intermediate

• Performed all essential roles and responsibilities of a fire fighter and EMT.

• Patient care, hospital reports and all necessary documentation for care provided.

• Participated in Haz-Mat training for Haz-Mat team role. Haz 1 & 2 Certified.

• Taught 3 sections of EMT training class.

• Utilized continuing education in chemical handling, public containment and methamphetamine laboratory

deconstruction.

Moved to Georgia to take care of critically ill family

Contact this candidate