Maria Sandra Carballido acp2jn@r.postjobfree.com

Profile

• Goal oriented professional with strong analytical skills, self-motivated, and well-organized, detail oriented

with abilities to perform as a team leader and player as well as trainer.

• Well-qualified Chemist with experience in R&D, Quality Testing and data review.

• Possess extensive experience in designing, reviewing, optimizing, executing and analyzing studies.

• Excellent written and verbal skills; can readily adapting communication style to technical level of

audience to facilitate understanding.

• Extensive experience in ICH, cGMP and GLP regulatory compliance.

• Written and prepared documents used for ANDA submissions.

• Bilingual, fluent in English and Spanish.

Professional Experience

Axcentria Pharmaceuticals Telford, PA

Analytical Chemist (03/ 2010 – 04/ 2014)

• Assisted analytical manager for the day-to-day running of the analytical laboratory and the mentoring of

junior chemist in the analytical department.

• Wrote develop and executed analytical method validation protocols, standard operating procedures (SOP),

CAPA programs and stability protocols.

• Testing of raw materials, intermediates, finished products and cleaning verification samples.

• Collaborated closely with formulation, manufacturing and production teams to ensure that raw materials

needed for production are tested and approved in time to enable a hitch-free production.

• Troubleshooting instruments and investigations of drug product out-of-trend (OOT) and

out-of-specification (OOS) in the analytical department. Provide technical support to manufacturing and

formulation departments.

• Coached and trained junior chemists in multiple analytical and instrumental techniques including HPLC,

FTIR, Karl Fisher and TOC resulting in self-sufficiency and improved group productivity.

Particle Sciences Inc. Bethlehem, PA

Analytical Chemist (08/2008 – 04/2009)

• Developed and validated analytical test methods for the identification and quantization of various Active

Pharmaceutical Ingredients (API) and preservatives, complying with cGMP, GLP and ICH guidelines.

• Performed analytical testing on raw materials, stability samples and finished product and reported data to

management.

• Written, reviewed and implemented appropriate SOPs and other documents as needed to maintain ICH

and cGMP/GLP regulatory compliance.

• Contributed analytical expertise to Pharmaceutical Science Development and Formulation team.

• Leveraged writing skills to prepare clear and concise technical reports on stability, potential impurity, and

degradation product and reference standards used in regulatory submissions.

Lehigh Valley Technologies Allentown, PA

Senior Chemist (02/2004 – 07/2008)

• Developed and validated stability-indicating chromatographic methods for assay and impurities/related

compounds profiling.

• Researched and developed dissolution and cleaning verification methods and validated these according to

internal and federal regulations.

• Wrote validation protocols, reports, test methods and SOPs. Trained junior chemists.

• Review data and documentation and investigation of OOS and OOT in the Analytical Department.

ANDRX Pharmaceuticals Ft Lauderdale, Fl

Senior Chemist, Research and Development (02/1994 – 01/2004)

• Performed assay and related substances method development and validation for intermediate and finished

products. Data review and document writing for NDA submission

• Provided support to Formulation Department with raw materials and stability testing.

• Group member for IQ/OQ/PQ team for computer system validation. General troubleshooting and

Metrology. Provided support to IT department.

• Performed testing based on compendia and standard test methods using techniques such as physical and

wet chemistry, spectrometric analysis (FTIR, UV/VIS, GAS, Fluorescent), as well as potentiometric and

gravimetric analysis.

• Purchasing general laboratory supplies and reagents.

Medi Save Pharmacies Boca Raton, Fl

Pharmacy Technician (06/1990 – 01/1994)

• Assisted manager with data input, dispatching, and verifying of prescriptions. Duties included control of

narcotics and medical supplies to all serviced nursing homes.

• IV technician certification.

• Developed fast and reliable methods to communicate with nurses and technical personnel so as to

improve patient service.

Chemical Packaging Inc Pompano Beach, Fl

Analytical Chemist, Research and Development (01/1990 – 06/1990)

• Tested aerosols and industrial cleaning solutions.

• Researched new products to implement quality and cost effectiveness.

Education

BS, Chemistry and Pharmacy (1986)

Universidad de El Salvador, San Salvador, El Salvador.

Publications

Evaluation and Diagnosis of Pharmacies at Hospital Rosales. (Regional Teaching Hospital). Pharmaklinik. Vol. 1

No. 3, p.153-155, 1987. Spain

Training

Laboratory cGMP/GLP (Apr. 2008): Delphi Analytical Services, through Lehigh Valley Technologies,

•

Allentown, PA.

Improve Peak Shape, Resolution and Analysis Time (Aug. 2003): Agilent Technologies, through Andrx

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Pharmaceuticals, Ft Lauderdale, and Fl.

Safety (Feb. 2002): Analytical Research Lab, Andrx Pharmaceuticals, Fort Lauderdale, and Fl.

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Computer Software (Jan. 2002): Agilent Chemstation/Chemstore User Training through Andrx

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Pharmaceuticals, Fort Lauderdale, and Fl.

Calibration Software. Blue Mountain. ANDRX Pharmaceuticals, Ft Lauderdale, FL.2002.

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Computer Software (Jul. 2008): Empower software from Waters Corporation through Particle Sciences,

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Bethlehem PA.

Technical Inventory

• HPLC/GC • FTIR

• Column Chromatography • UV - Vis

• Karl Fischer Titrimeter • Microsoft Office

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