Skills

Why should you consider my application for a job? Because I am coming with an analytical mind, an innovative attitude and a comprehensive set of acquired competencies that could add value to your teams of motivated scientists. Working in the research and development department, coupled with having responsibilities within my company\'s CRO, helped me get a panoramic picture of all the stages of the pharmaceutical development process and their impact on the finished product.  
I became aware of the difficulties of the process while being involved in the development of a gastro-resistant highly variable generic drug product, from the first formula to the last signature on the clinical trial report. My involvement was notable because I was responsible for the in-vitro testing activity and the statistical evaluation of the clinical trial data. This study made me realize, among other things, the impact of details, like an imperfect sampling scheme, on the bioequivalence of two products, and I discovered possibilities to avoid similar problems, checking, for example, consistent in-vitro dissolution data.
Regarding my experience as an analyst, I performed multiple tests in various stages of pharmaceutical development (UV-vis spectrophotometry, HPLC, dissolution, diffusion) and immunoassay techniques in the detection of residues in biological matrices. I participated in several interlaboratory testing schemes, both within the Romanian residues laboratories network and in FAPAS proficiency testing system.
I got comfortable in method developing, improving and validating, designing and interpreting (including statistical aspects, like trends, variations, the uncertainty of the measurements, data comparability)  analytical processes, reporting studies, optimizing and maintaining pieces of equipment, anticipating needs in the analytical field to minimize risks and maintain the GLP certification. I proved myself as versatile, fast-learner and technical skilled and that helped me successfully switch positions and industries.
Concerning my experience in documentation, as the head of In-vitro Testing laboratory, I was a part of the process of designing DMFs and FPPs, along with the formulators, other analysts and the regulatory affairs. The successful activity of the above-mentioned teams was concretized in obtaining marketing authorization for 3 injectable products, 3 topical products, 5 oral drugs during the last 5 years, and is an accurate indicator that I perfected my working style, my documentation skills, that I managed to collaborate and communicate efficiently towards the optimization of the processes, despite tight deadlines and budgetary constraints.  Precisely, I contributed to 3.2.S and 3.2.P section of Module 3, and some parts of Module 5. I was also involved in analytical methods validation, co-validation or transfer procedures. For the sections within my responsibility area, I was also in charge of preparing responses for the authorities\' observations (and the trickiest ones I considered to be Serbia\'s and Poland\'s NRAs out of my current experience).
Talking about my interest in software, automation and data handling, I want to mention that I am passionate about computers and have learned multiple software programs until now (equipment\'s software, statistical software: Kinetica, Phoenix and MS Office). I have been working with large data sets from bioequivalence studies and analytical methods\'validations.

Time and Spatial Flexiblity

Freelancing position requested

Get In Touch