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Clinical Operations Project Manager and Senior Research Biologist with extensive experience in the Pharmaceutical Industry in the US and EU. Experienced in in-vitro assay development using bioanalytics with strong focus on developing and applying automation solutions. Recognized for Project Management, Team leading roles, Analytical skills in generating and analyzing research data, making timely results driven recommendations and decisions. Organized, detail oriented with excellent communication, presentation, interpersonal and leadership skills as well as proven ability to work as part of a team and independently in a cross functional, multicultural, and global environments. Recognized as a problem solver; resourceful and agile learner; efficient in obtaining new skills.Key Proficiencies and Technical Skill:Training & CertificationsGMP; GLP; GCPProject ManagementTechnical writingExecutive Presentation SkillsYellow Belt 6 SigmaDistinguished ToastmasterLCMSMSWaters Zevo TQ; Quantiva
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Sample Information Systems ManagerRoche Oct 2018 - Aug 2022Basel Area, Switzerland• Responsible for managing requests in support of the Clinical Trials Pharma Biosample Services (PBS) connected to samples information management (data discrepancy reconciliation, inventory, data management, samples set searches), storage, samples processing and distribution to internal and external teams and Vendors• Provided direction and guidance to the Associates to enable issues resolution, request triage, delivery and sample information management activities locally and globally and served as escalation channel for the unresolved issues• Collaborated with Global Study Stakeholders and external Vendors to ensure that samples receipt, distribution, processing, storage requirements are met and aligned with the Study Protocols and clinical analysis timelines• Accountable for adherence to sample information standards and compliance to maintain sample data integrity -
Clinical Project Support CoordinatorRoche Jan 2018 - Sep 2018Basel Area, Switzerland• Within the Product Development Global Clinical Operations department I served as the primary point of contact for Clinical Study Teams, Biomarker Operations Project Managers and Biosample Analytical Managers for operational activities related to the collection, distribution and storage of biological samples from the company sponsored clinical studies and trials • Supported multiple Global Study Management Teams by directing Biosample Repository Management operations activities including sample discrepancy reconciliation, fulfillment of shipment and information requests, generation of query reports and metrics summaries• Worked with various internal and external stakeholders to resolve or escalate appropriately sample data issues • Closely collaborated with external vendors and Studies stakeholders to ensure that sample receipt, distribution, processing, storage requirements are met and aligned with the Study Protocols and clinical analysis timelines• Represented Biosample Repository Management at the Operational Clinical Study Team meetings; prepared and presented updates regarding sample reconciliation and discrepancy management activities • Provided training and guidance to internal and external business partners in the sample reconciliation and discrepancy management process
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Sr Research BiologistMerck Nov 2012 - Nov 2016United States• Developed In-vitro High throughput assays (isolate enzyme and whole cells) and LC/MS methods for Medicinal Chemistry support• Developed & validated methods for the quantitation of small molecules & endogenous metabolites in biological samples (whole blood, plasma, tissue, urine, etc.) using a variety of instrumental techniques (HPLC, UPLC, LC-MS/MS)• Performed weekly screening assays (sample prep, LC/MS set-up, data generation, QC, uploading to DB and reporting)• Served as a Project Coordinator for external and internal collaborations; supported strategic sourcing of externalized assays• Trained department members; provided tech consultations in the use of lab automation, liquid handling equipment• Served in the active Leadership role across a variety of Internal and External Committees; member of SLAS New Product Award committee Selected accomplishments:• Served as a Project Coordinator for Clinical cohorts’ samples shipments, cataloguing and storage, samples aliquoting, distribution and tracking; maintained communications with external and internal collaborators (UTSW, Albert Einstein College of Medicine, CVD). My efforts contributed to the development of a strong collaboration with one of the leading academic labs in Cardiometabolic Disease. My work also played a key role in generating high quality Phenotypic data which was used by UTSW & Merck for validation and identification of new CMD targets • Successfully completed 7,200 samples set from the Dallas Heart Study UTSW – over 29,000 samples were assayed for Bile Acids, Branched Amino Acids, and Lipids. In the process of the project I developed, validated and used custom automation processes to increase throughput and minimize data variability • Served as a key contributor in bringing automation solutions whiting the department and the network (conducted training, provided numerous technical consultations, assisted with custom application development for a wide range of automation platforms).
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Research ScientistMerck Apr 2009 - Sep 2012Rahway, Nj Usa• Provided analytical evaluation (biochemical and LC/MS/MS assays) for ex-vivo samples from the Central Pharmacology and Franchise based teams in support of programs in Diabetes and Cardiovascular Therapeutic areas • Developed assay (analytical, biochemical, and whole cell)• Served as a key contributor in optimization and development of automation solutions for various sample prep flows and assays set-up (both newly developed and adaptation of existing manual assays)• Training of group members in the use of various Liquid Handling and robotic equipmentSelected accomplishments include:• In the newly organized centralized Bioanalytical function I served as a key contributor to the laboratory design and set-up: identified, purchased and in some cases identified and redeployed necessary equipment; optimized sample prep and assay flow by introducing automation. Thus, our lab consistently generated high quality data with turn-around time of 24 -72 hours for Target Validation, Lead Optimization, Preclinical Candidate (PCC), Model and Assay development projects across different animal species. • Initiated and Chaired Departmental Committee that provided forum for Associates to present their on-going work
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Research MicrobiologistMerck Nov 1999 - 2008Rahway, Usa• Served as a key contributor to the group’s small molecule screening efforts utilizing a wide range of automation equipment • Generated and analyzed screening data, organized and presented research results to project working groups• Protocols and custom applications development (assays, automation, validation, QC)• Provided protein biochemistry support to ongoing departmental projects (Western blot, SDS gels, Protein Quantification)• Participated in the Departmental Strategy meetings• Trained and assisted other members of the Department in use of various instrumentation, software, Data Bases, and robotic equipment• Supervised and trained summer interns Selected accomplishments include:• Piloted development of the analytical support using LC/MS/MS platform to evaluate in-vitro PK/PD studies (based on a hollow fiber model) of MRL preclinical development candidates. • Served as one of the initial key contributors to the transfer and validation of a newly acquired in a major MRL licensing initiative technology focused on the identifying new matter with antibacterial activity against Gramm+ bacteria. Conducted necessary validation experiments to evaluate the technology, provided technical expertise in automating the process, visited the collaborator’s site to identify and troubleshoot the issues during the transfer.
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MicrobiologistCelsis Laboratory Group Oct 1998 - Nov 1999Edison, Nj Usa• Worked in compliance with GMP and GLP guidelines • Primary responsibilities included microbiological analyses of raw materials, bulk and finished products of pharmaceuticals and cosmetics utilizing a wide range of assays and techniques • Maintained laboratory's culture collection, performed monthly transfers • Conducted environmental monitoring of the FDA regulated Microbiology lab • Reviewed and revised existing SOPs• Prepared results reports for the clients and conducted investigations for the out of spec results• Calibrated and validated Laboratory equipment
Olga Berejnaia Skills
Olga Berejnaia Education Details
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Microbiology, General
Frequently Asked Questions about Olga Berejnaia
What is Olga Berejnaia's role at the current company?
Olga Berejnaia's current role is Senior Research Biologist with extensive experience in the Pharma Industry. Clinical Operations, PM, Assay development, Bioanalytics & HTS.
What is Olga Berejnaia's email address?
Olga Berejnaia's email address is ol****@****che.com
What is Olga Berejnaia's direct phone number?
Olga Berejnaia's direct phone number is +173257*****
What schools did Olga Berejnaia attend?
Olga Berejnaia attended Dnipropetrovs'kij Nacional'nij Universitet.
What skills is Olga Berejnaia known for?
Olga Berejnaia has skills like Pharmaceutical Industry, Biotechnology, Drug Discovery, Drug Development, Molecular Biology, Assay Development, Life Sciences, Clinical Development, In Vitro, Cell Culture, Validation, Biochemistry.
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