Company Support

MALGORZATA (MARGARET) MACIASZEK

**** *. ******** ***. • Arlington Heights, IL 60004 • 847-***-**** • ************@*****.***

PROFESSIONAL EXPERIENCE

Summary: Organized and results oriented Analytical Chemist/Scientist offering extensive knowledge in qualitative/quantitative

analytical techniques with excellent supervisory skills. Experienced in chromatographic method development and validation as well as

GLP and cGMP procedures and documentation required for FDA product submissions. Specialty areas are HPLC, GC, IC and

analytical troubleshooting.

2005-2014 WATSON PHARMACEUTICAL /ACTAVIS Mount Prospect, IL

A global specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products

Pharmaceutical Technology Analytical Specialist II

• Responsible for analytical testing of finished drug products, stability, cleaning validation and raw material

samples following cGMP test methods, SOPs and protocols

• Developed, validated, and transferred drug substance and drug product assay, impurity and dissolution methods

• Supported the evaluation of Alternate API’s sources by characterization of new chemicals and evaluating

specifications

• Participated in systematic investigations for commercial and late stage development products

2004-2005 BAXTER HEALTHCARE Round Lake, IL

A global healthcare company: producer of plasma-based and recombinant proteins, intravenous solutions, and products for peritoneal dialysis

Research Associate II

• Provided analytical support to R&D and manufacturing operations within the Product Development Group

• Designed, executed and led over a dozen validation studies

• Conducted assessments of current analytical methods used in product release and stability studies

2002-2003 THE NUTRASWEET COMPANY Evanston, IL

The world's largest producer and commercial marketer of aspartame and the developer of neotame, a sweetener and flavor enhancer approved by

the FDA in July 2002

Senior Research Chemist

• Coordinated analytical support for R&D and manufacturing operations within the company

• Supported the Reference Standards program by providing quality analytical data for sweetener development and

business operations

• Carried out a number of stability studies to support delivery forms and applications of neotame

• Conducted HPLC analysis of two main products to support equivalency programs. Ensured that all activities

were performed according to the cGMP as well as internal standard operating procedures

• Supervised analysts in instrument training, data analysis, data interpretation and documentation

2000-2002 ALBANY MOLECULAR RESEARCH, INC. (FORMERLY GREAT LAKES FINE CHEMICALS) Mount Prospect, IL

A chemistry-based drug discovery and development company, focusing on applications for new small molecule prescription drugs

Research Chemist

• Led a group of chemists who provided analytical support for a large contract for the NutraSweet Company

• Supervised projects in support of regulatory, food science and manufacturing functions

• Developed and validated analytical methods necessary to perform stability studies supporting neotame Food

Additive Petition

• Planned and executed certification and recertification of reference standards

1990 - 2000 THE NUTRASWEET COMPANY Mount Prospect, IL

Research Chemist (1996 – 2000); Chemist (1990 – 1996)

• Provided analytical support for R&D and manufacturing operations within the Process Support group

• Designed and executed stability studies for a new sweetener food additive petition

• Developed and validated a number of stability-indicating analytical methods in support of GLP stability studies

and Preclinical / Clinical safety studies supporting FDA product approval

• Contributed to process optimization of new sweetener application formulations and delivery systems

EDUCATION & PERSONAL

Jagiellonian University, Bachelor of Chemistry, Master of Chemistry Krakow, Poland

Professional Memberships: American Chemical Society

Interests –Traveling, Skiing, Camping, and taking walks with our family dog, a black lab

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