CHUKWUEMEKA P. ONUKWUGHA

**** ****** ******

South Plainfield, NJ 07080

908-***-****

908-***-**** acz7u1@r.postjobfree.com

OBJECTIVE

To pursue a challenging career in Pharmaceutical Industry with a progressive organization offering opportunities for growth and career advancement.

PROFILE

•Over 15 years of experience in analytical chemistry, laboratory controls and technical services.

•Ability to work independently, with minimum supervision, problem solving and to work as a team. Excellent knowledge of pharmaceutical analysis, quality control and Good Manufacturing Practices.

•Special skills in instrumental analysis: HPLC, GC, UV, IR and wet chemistry.

•Have commanding experience in method transfer technology and techniques.

•Strong chromatographic review and notebook auditing experience.

Knowledge of FDA guidelines relevant to analytical method validation and stability of ANDA drug product.

Knowledge in Leachables, API, Preservative and related degradation products.

Knowledge in writing test methods, method verification/validation protocol and reports.

Have Good effective Communication and can demonstrate ability to prioritize conflicting demands.

Good in complying with policies, procedures, rules, regulation and at the time maintaining confidentiality.

KEY STRENGTHS Laboratory Techniques

Karl Fischer Titration, Potentiometric Titration, Specific Rotation (Polarimetry)

Particle Size via Auto Sieve Apparatus and Refraction Index

Melting and Boiling Point Determination. Instrumentation, Normal and Reverse Phase, Isocratic and gradient HPLC. A Strong Knowledge of Empower 1, 2&3 Software. GC, Thin layer chromatography. Automated Dissolution System. Review Normal and Extended Release Tablets. Moisture Testing Solution Chemistry etc. FTIR, UV/VIS, TLC Spotter and Scanner, Wet Chemistry. Chem-station (HP) Mass Spectrometry. Fractional Vacuum and Steam Distillation, Specific Gravity Viscosity Tablet Disintegration and Dissolution

The use of above for Assay, Related Compounds, Uniformity of Dosage and Validation of Products.

Have the knowledge and ability to demonstrates, executes the Specificity, Limit of Detection (LOD), Limit of Quantification (LOQ), Linearity, Accuracy, Repeatability & Intermediate Precision, Solution Stability, Relative Response Factor (RRF) USP Method Equivalency Study, RLD Product Comparisons.

Literature

Familiar with the cGMP Protocols, Reagents, General Tests, Methods and Monographs

Associated with the United States Pharmacopoeia, the European Pharmacopoeia, the National Formulary and daily use of SOP Methods.

CYALUME TECHNOLOGIES 2016 to present Senior Chemist

Q/C and R/D Chemist method verification USP Internal auditing.

ISO 9001 and ISO 17025 and other regulatory process.

G&W Laboratories Inc., South Plainfield NJ 2012 to 2016 Senior Scientist

Performing Methods Transfer technology and techniques Using HPLC, UPLC, GC and other laboratory equipment.

Conduct Validation of methods using the protocol and Verifying the vendor method as needed. Conduct and write methods for routine analysis.

Contribute in SOPs writing and updating.

Technically supervise and mentor junior chemists in analytical techniques such as HPLC, GC, FT-IR, and UV etc.

AUROBINDO PHARMACEUTICALS, Dayton, NJ 2011 to 2012 Senior Chemist

Validated Analytical Method for the Assay active and Drug Release Product

Executed Validation activities as described in Validation Protocols. Assured that all Test Data are gathered and recorded in accordance with cGMP requirements.

ACTAVIS PHARMACEUTICALS, Elizabeth, NJ 2001 – 2011 Chemist 3

•Validated Analytical Method for the Assay active and Drug Release Product.

•Authored and reviewed quality control SOP (Standard Operating Procedure) for laboratory scale-up and in compliance with Company’s internal Quality System, cGMP and other regulatory organization.

•Conducted Stability Studies on Products and cleaning Validation using the protocol.

•Participate actively on project teams and mentor junior level analysts in support of team Objectives.

•Reviewed and Released of Analytical Data assuring the reliability and quality of data, meeting all internal and external quality standards.

•Performed routine Stability work on Projects of different Classes of Drugs.

•Executed Validation activities as described in Validation Protocols. Assured that all Test Data are gathered and recorded in accordance with cGMP requirements.

•Evaluated data against established acceptance criteria and document then as required.

•Conducted investigations and complete all required documentation in a timely manner, which saved the company millions of tablets already manufactured.

PF LABORATORY, Totowa, NJ 1997 – 2000 Senior Chemist

•Performed Assayed Bulks and Intermediates, Raw Materials, Finished and Stability Products.

•Released Raw Material and Performed Routine Drug Testing in accordance with USP procedures and compliance for the Company’s internal Quality System, cGMP and other regulatory organization. Reviewed and audited analysts notebooks, and assist with

Laboratory house keepings .

RUTGERS UNIVERSITY, Newark, NJ 1995 – 1997 Research Assistant

Assisted in Molecular Structure Analysis. Using X-ray Technology, HNMR, C-13NMR, HPLC, and Wet Chemistry.

EDUCATION

BS, Chemistry and Biology, Rutgers University, Newark, NJ

AFFILIATIONS

Member of American Chemical Society

Member of Rutgers University Chemistry Club

Member of OSHA (Occupational Safety and Health Administration) ID# 12-700******

Member Actavis Pharmaceutical Laboratory Safety Committee from the year 2008 to 2011 The

Chairperson Africa Student organization from 1996 to 1997, RUTGERS UNIVERSITY, Newark, NJ

TECHNICAL SKILLS

Word Perfect 5.1, Microsoft Word, Microsoft Excel, Pascal, Millennium Chromatography Manager, Millennium 32, Empower 1,2&3 Software. Windows NT, Electronic US Pharmacopoeia.

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