Customer Service Raw Materials

ANTON DIMOV

* ******* ******, **********, ** ****9

Tel: 201-***-****

E-mail: *******@*****.*** or

*****.*****@*****.***

SUMMARY:

1.Self-motivated Scientist with a decade of experience in analytical method development, validation, transfer, and testing in quality control and research & development settings.

2.Ability to prioritize tasks and deliver quality results based on available resources and projects / methods complexities in a fast paced environment.

3.Foster a positive environment for peers to perform daily tasks at the most ethical manner, and proven ability to motivate teammates to go above and beyond to deliver quality results, often with attenuated timelines

4.Strong expertise in method development, routine testing, and troubleshooting of various analytical methodologies such as Atomic Absorption Spectroscopy (Graphite Furnace and Cold Vapor), ICP-OES, ICP-MS, UV/VIS, FTIR, TGA/DSC, TLC, KF, Autotitration, Polarimetry, Dissolution, GC, HPLC and a wide range of wet chemical analytical methods.

5.Well versed in USP/FCC/JP/EP/BP, ICH guidelines, ASTM, AOAC methodologies. Fully compliant with cGMP, GLP, OSHA, FDA & DEA regulations.

6.Possess strong affinity to learn and utilize new analytical techniques and instrumentations to solve problems at hand.

EXPERIENCE:

Aerotek Scientific on assignment with Amneal Pharmaceutical, Piscataway, NJ

Analytical R&D Chemist III (contract) December 2016 - February 2017

Performed Validation testing on inhalation finished products (Assays, dosage/content uniformities testing, Impurities/degradation, etc.) in accordance with the established internal procedures and FDA guidelines.

Performed analysis with metered dose inhalers (MDIs) and dry powder inhalers (DPIs) using USP Chapters <5>, <601>, <604>, <621>, <905> (content uniformity, assays, aerodynamic particle size distribution, leak rate testing, alcohol content, shot content, etc.) using HPLC and GC as well as identification tests.

Supported pre-ANDA and NDA studies of aerosol asthma drugs.

Troubleshot and optimized existing analytical methods for qualification and release testing of the researched drugs.

Adecco Medical on assignment with Vitaquest International, West Caldwell, NJ

Senior QC Chemist (Contract) November 2016-December 2016

Performed routine analysis (Assays, Impurities/degradation tests and heavy metals) on raw materials, in-process, stability, and finished products/formulations (tablets and capsules) in accordance with the established procedures using ICP-MS, micro-oven, disintegration tester apparatus, and HPLC.

Prepared proper cGMP documentation for all incoming and outgoing products (solid dosages and semisolids) and generated reports for the tested products.

Identified and solved instrumentation problems (Syngystix ICP-MS software), as well as optimized test microwave digestion methods for elemental analysis

Prepared new lab reagents when supply was used up or expired

Maintained cGMP/GDP laboratory notebook according to SOP

Disposed unused samples/solutions in the correct waste container in accordance with the OSHA guidelines and the company specific safety SOP and hygiene plan.

SGS Life Science Services, Fairfield, NJ, Lead Chemist,

Sept. 2013 - Sept.2016

Supervised a staff of up to 10 chemists and chemistry technicians. Prioritized and scheduled workload and deliverables. Provided training and technical guidance to peers on compendia, clients’, and in-house methods).

Successfully minimized delays in meeting tight turnaround timelines. Increased team productivity and efficiency by 50% with streamlining documentation of essential information, formulating routine testing worksheets, and bundle same testing among different sample groups within the current year.

Prepared testing protocols for raw materials, finished products, and APIs utilizing classical wet chemistry and HPLC techniques.

Executed approved method validations and method transfers, research protocols. Prepare validation and R&D reports.

Created, updated and improved in house SOPs.

Conducted routine physical, chemical, and instrumental analysis of raw materials and finished products (tablets, capsules, parenterals, devices, aerosols, liquids, creams, and gels) as per USP/ FCC, EP, JP and BP monographs. Prepare standards and samples for analysis and run the instrumentation independently including, but not limited to, various chromatographic systems, Karl Fischer (Coulometric and Volumetric), UV/Spec, various wet chemistry analyses, HPLC, IR, ICP, AA, TGA, DSC, auto-titrators, TLC, GC and dissolution apparatus.

Ensured that the client receives quality data by reviewing laboratory data for accuracy, clarity, and adherence to GMP and/or GLP regulations

Performed statistical trending on stability samples for active pharmaceutical ingredients and drug products

Worked with senior management and quality assurance teammates in performing and resolving Out Of Specification investigations, deviation impact assessments, and CAPAs as per internal or clients’ quality systems.

Communicated and work with client technical services to assess additional work requested by client is outside of the scope of the pre-established quote, and updated quote as needed.

Solved complex analytical, process and technical problems.

Performed lab equipment maintenance, daily check and scheduled monthly and annual calibration.

SGS Life Science Services, Fairfield, NJ, Chemist, 2009 – 2013

Solid expertise and extensive experience in method development, troubleshooting, transfers and validations for API, excipients, packaging materials, medicinal devices using methodologies such as Atomic Absorption, ICP/OES, coulometric/volumetric titrations, KF, UV/VIS spectroscopy, etc.

Performed routine assay, impurity, identification, physical, and elemental testing for raw materials, excipients, and finished products, such as Lanolin, Xanthan Gum, Sodium Hyaluronate, Omega-3 Acid testing, Pectin as per specific monographs, in-house, or clients’ methods.

Performed elemental analyses testing with ICP for all types of plastics and various medicinal devices in accordance with the EP, raw materials (Titanium Dioxide, Cisplatin), finished products (lactic acid, chelate i.v. infusion formulations, Vitamins);

Developed and validated elemental analyses with AA using internal standards, external standards, or standard addition techniques on various packaging components, omega-3 acids, sodium polystyrex sulfonate, cisplatin, etc.

Performed solvent exchange/extractions techniques such as Soxhlet extraction, microwave digestion, and subsequent sample concentration via turbovap evaporation and/or centrifugation.

Performed testing on proteins, antibiotics, and enzymes using wet chemistry techniques via UV-Vis, TLC (Vancomycin, Streptomycin, and Tuberculin (USP <621> and EP 2.5.33/ 2.5.16 respectively.), Dissolution<711> (Dexamethasone, Vancomycin, etc.)

Assisted metrology with annual and semi-annual calibration of instrument as well as the OQ/PQ of newly acquired instrumentations such as AA, ICP/OES, polarimeter, autotitrators, etc.

Worked closely with customer service and technical support representatives to meet clients’ expectations and managed accounts payable.

SGS Life Science Services, Fairfield, NJ, Chemistry Technician, 2005 – 2009

Conducted thorough QC testing of raw materials and finished products in accordance with USP/ FCC, EP, JP and BP monographs.

Performed stability testing as per compendia (USP and EP) as well as clients’ specific methods (such as Xanthan Gum, Hydroxyl Propyl Cellulose, Ethylcellulose Aqueous Dispersion, identification and limit tests, Acid/ Hydroxyl/ Saponification Value testing, Nitrogen and Ammonia determinations, amperometric/potentiometric titrations, viscosity testing).

Performed routine daily instrument verification as well as quarterly and semiannual calibration of Brookfield viscometers, UV-VIS spectrometer, tensiometers, etc.

Teaneck Dermatology LLC, Teaneck, NJ, Administrative Medical Assistant, Medical Biller, P/T, 2004 - 2008

Sterilized all medical instruments.

Assisted with biopsies and collected biopsy specimens.

Prepared and assisted doctor in procedures (surgeries, minor wound care, and stitches removal).

Scheduled appointments, prepared and maintained charts, collected co-pay, processed prescriptions, performed filing and billing, data entries.

Processed EOBs, updated procedure code files and price schedules.

Communicated with pharmacies, insurance carriers and medical labs.

Elisabeth Hospital, Vienna, Austria, Lab Assistant, P/T, 1995 – 1997

Assisted doctors and nurses in routine patient care operations

Responsible for histo-pathological analyses of samples

Performed phlebotomy and routine blood and tissue cultures tests.

Preparation of blood cultures, cytological and morphological cell and urine

analyses.

Familiar with staining techniques and fixation methods.

COMPUTER SKILLS:

Proficient in MS Office (MS Word, MS Excel, MS Powerpoint), EViews, Statistica, C++, LIMS, Empower3, ICP-MS Syngystix as well as company specific inventory and ordering software.

EDUCATION:

Rutgers University, New Jersey, B.A. in Economics and Management, 2009

USP Dissolution Certification, 2015

Vienna University, Vienna, Austria, B.S. in Medicinal Chemistry, 1992-1997

The Plaza School of Technology, Paramus, NJ, courses in Pharmacy, 1999

ADDITIONAL INFORMATION:

US citizen

Multilingual: Bulgarian (native), English, German, Russian

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