High School Project

**** ****** ***, *** 1-805-***-**** E-mail: *********@*****.***

Simi Valley, Ca 93063

Liliana Marghitoiu

Objective

Work in a challenging team, which will require fully my skills, creativity, commitment, and enthusiasm.

Have the possibility to improve myself, learn and use the latest technologies, and participate in the

creation of the future ones.

Accomplishments:

• Discovered the antioxidant compound from Bioreactors bags and wave bags ( Irgafos 168

breakdown compound) which has a detrimental effect on Amgen cell line growth. This discovery

initiated the change in Bioreactor bags manufacturing.

• Efficientize the compound identification process in Amgen Extractable/Leachable department by

designing and developing compounds libraries for LCMS and LCUV and reducing project

timelines to half.

Experience

2/13-Present – Associate Scientist –Amgen, Thousand Oaks, CA

10/10-2/13- Senior Associate- Amgen, Thousand Oaks, California

• Oversee the GC/GCMS and LC/MS of Extractable and Leachable department in Amgen. Responsible

to determine the extractable and leachable compounds, structure elucidation of unknown chemicals

from devices, containers, study interaction of polymer degradation with drug product.

• Provide impute on process and product nonconformance, FDA and other regulatory agencies

application for drug products, containers in contact with drug product and delivery devices. Manage

competing timelines and prioritize critical tasks. Actively participate in directing the evolution and

defining the role of the projects, department and individual projects workflow, report writing and

publication. Training and guidance for new chemists.

9/05-10/10- Chemist/Scientist- Columbia Analytical Service, Simi Valley, CA.

• Scientist IV in the Volatiles Air Lab. Performed air samples analysis through GC/MS and

Thermodesorbtion, data processing and calculation, QA, reports, data validation, review and

approval. Provided training for new chemists, organized workflow and assigned projects.

Instrumentation troubleshooting and maintenance. Methods development and implementation.

Maintained proper record keeping, calibration, and repair of analytical instruments and laboratory

supplies to ensure compliance with regulatory agencies and ISO 9000 Standards. Revised and update

SOP’s, lab documentation and methods validation. Propose, design and implement instrument

modification, software change and update, new QA programs to improve production, quality and cut

costs. Deliver quality and timely results via the use of appropriate tools.

• Manage competing timelines and prioritize critical tasks. Actively participate in directing the

evolution and defining the role of the project.

• Project management by direct customer interaction: providing project status updates, feedback, and

appropriate reporting.

05/04-09/05-Chemist-Capco Analytical, Ventura, CA.

• Solely responsible with running the Gas Chromatography - volatiles lab section performing the

following duties:

QA program design, implementation for the lab licensing EPA audit, writing and updating SOP’s,

nonconformance and corrective /preventive actions review, laboratory results validation, training for new

chemists, internal audit.

Method development and implementation, order supplies and parts needed for the instrumentation

troubleshooting and maintenance, purchased new lab instrumentation and lab equipment.

04/02 – 04/03 - Laboratory Assistant – Esoterix Endocrinology - Calabasas, CA

1997-1999- Chemistry and Physics – High School Teacher,

Timisoara, Romania-Taught chemistry and physics - High School level.

Skills

• Knowledge of laws and regulations in an FDA regulated environment ( Biologics, Dietary

Supplements, Medical Devices, Drugs, International Regulations )

• Expert on GC;GC/MS,HPLC,HPLC/MS analytical techniques

• Expert in structure elucidation and small molecule compounds identification from complex matrix.

• Proficient in using Microsoft Office.

• Chemstation, Chromeleon, Xcalibur, LIMS. Familiar with BLAST, ICM, Swiss-Prot and other

programs used for protein search and characterization. Beginner to intermediate level in C, VB, C++,

HTML (able to modify and write VB macros).

• Knowledge of FDA, EPA, HACCP, GMP and GLP regulations, ISO‘s series and Lean six Sigma

training.

• Well organized, quick learner and very detail oriented. Creative, superb problem solving, hard

working, self motivated, conscientious. Attentive to detail, good interpersonal skills, good

communications skills.

• Able to efficiently multi-task and prioritize assignments under specific deadlines.

• Ability to work alone or as part of a team with willingness of having work done

• Able to work in a collaborative environment with a positive leadership style and a hands-on approach

that emphasizes team work, collaboration, influencing, motivating, and consensus and team building.

Education:

• 2012-2013- Regulatory Affair certification ( USC)

• 2012-Present Regulatory Affair Master USC(expect graduation 2014)

• 2005-2007 MS degree in Biotechnology and Bioinformatics, California State University Channel

Islands

• 1993-1997 Bachelor degree with double major in Chemistry and Physics. University of West

Timisoara, Romania –Faculty of Physics and Chemistry

1997 – 1999 Engineering Food Technology - Timisoara, Romania-Faculty of Food Products

Technology

Publications:

Hammond, M., et al., Identification of a leachable compound detrimental to cell growth in single-use

bioprocess containers. PDA J Pharm Sci Technol, 2013.

www.ncbi.nlm.nih.gov/pubmed/23569073

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