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Click here or scroll down to respond to this candidateCandidate's Name
Telephone: PHONE NUMBER AVAILABLE Email: EMAIL AVAILABLE
Summary
Chemist with professional experience in analytical work under GMP/GLP requirements and
adherence to Federal and ISO regulations.
Worked in areas of Research & Development, New Business Development, Quality Control and
Assurance.
Demonstrated leadership in project management for method development and validation, test
method transfer, product formula improvement and new product formulation, product stability
investigations, competitive products benchmarking.
Experience with testing according to USP/NF, EP, ISO and established SOPs utilizing
instrumental, wet chemistry and physical testing techniques (HPLC/UPLC, Spectrophotometry,
Enzyme activity degradation, Viscometry, Titration - potentiometric and ion-selective electrode,
Conductivity, pH, Refractometry, Specific Gravity, Detail Reproduction,
Strain-in-Compression, Shore Hardness).
Computer skills:
MS Office (Word, Excel, Outlook, PowerPoint, Solomon); HPLC - Waters Empower 2 and 3,
PeakNet, Shimadzu; TrackWise (complaints/CAPAs); patent search.
Professional experience
11/2014 - 05/2017: Sonar Products, Inc., Carlstadt, NJ
Developed new and validated new and existed HPLC methods for testing of Rx and OTC topical
Preparations - creams, lotions, ointments, otic drops
Designed and executed method of HPLC test methods
Performed product stability studies for new and established product formulas
Investigated product complaints and OOS (out-of-specifications) events for root cause
Prepared Validation Plans and Reports, Work Instructions and Stability Summaries
Performed method transfer and optimization of HPLC methods to UPLC
4/1999 10/2014: Sultan Healthcare - Division of Dentsply International, New Jersey
Set-up of in-house quality control for products by transferring, optimization and
validation of previously outsourced to contract lab HPLC analysis
Interpreted and executed new test methods from reference sources (USP, EP, ISO
standards, contract lab test methods), wrote work instructions and trained other lab
personnel on methods and techniques
Performed calibration, maintenance and troubleshooting of laboratory equipment,
prepared and standardized solutions, ordered and maintained laboratory supplies
Designed and conducted stability studies by creating protocols and plans, testing samples,
analyzing test data and summarizing results to establish product shelf life and expiration
labeling
Formulated new products in accordance with marketing strategic plans and conducted
technical leading of projects and design reviews within the framework of GIP (Global
Innovation Process) for new product development formulation process
Prepared new product prototype samples and lab batches for evaluation by marketing
group or customers and for stability investigations; assisted in scaling up formulas for
manufacturing
Provided technical support to Customer Service and Complaints departments on product
inquires and complaints
Performed investigation of out-of-trend events in QC testing and methods transfer,
determined root cause of product non-conformances and developed corrective-preventive
action plans including improvement of existing product formulas or optimization of
batching procedures when necessary
Assisted contract manufacturer (Caulk - Division of Dentsply International, Delaware)
with transfer of Sultan/Dentsply test methods; consulted on OOS, product
non-conformance or stability issues events; performed product evaluation when changing
raw material suppliers or adjusting batching procedures
In collaboration with other departments within the organization worked on development
of Product Risk Management, Product Design History and Product Technical files,
MSDSs, DFUs, submissions for product foreign registration and EU Declarations of
Conformity. Participated in internal audits
Before 1999: Chemist, Ukraine
R&D Chemist - R&D Lab at Analytical Department of Chernovtsy (Ukraine) State University
Chemist - Certification Lab for imported foods, Chernovtsy (Ukraine)
Technologist - Circuit boards plant, Chernovtsy (Ukraine)
Education: MS in Chemistry. Chernovtsy State University, Ukraine |
