Daria Ashcheulova Email & Phone Number

Remote

Main responsibilities:- Supervising and developing a team of subordinates, including motivation, skill development, and task allocation.- Coordinating international projects, including planning, tracking progress, and preparing comprehensive reports.- Representing the company's portfolio and capabilities to potential partners and stakeholders.- Conducting negotiations with partners to determine project scopes, timelines, and costs effectively.Achievements for the role:- Successfully guided a team of four subordinate employees, achieving high ratings as Head of the group from functional and cross-functional colleagues and management.- Managed over 20 international transfer projects across MENA, LATAM, and Asia regions, overseeing various stages from feasibility checks to project closure.- Leding a critical company project involving over 500 tasks and a cross-functional team of more than 100 performers, meeting extremely short timelines.- Developed a novel approach for calculating technology license costs, becoming the first applied instrument for the company in this area.

Remote

Main responsibilities:- Overseeing technology transfer projects to external partners (transfer out) for MABs molecules and vaccines, including partner technical assessment, agreement development, cost calculations, resource planning and assessment, leading working groups, and monitoring project implementation.- Managing projects for contract manufacturing localization (transfer in), involving technical capabilities assessment, project implementation calculations including evaluation of internal production costs, manufacturing operation durations, analytical and technology transfer costs, and CAPEX assessment.Achievements for the role:- Managing of COVID-19 vaccine localization concurrently with its transfer-out, navigating short timelines, stringent intellectual property requirements, and engaging internal and external stakeholders, as well as government and regulatory bodies.- Conducted feasibility checks for five transfer-in projects and successfully closed one transfer-in CMO project.- Oversaw accounting for two international subsidiary units.- Managing of five transfer-out projects.- Achieved promotion to Head of the group within eight months.

Moscow Region, Russian Federation

Main responsibilities and achievements:- Ensuring compliance of raw materials and excipients for sterile injectable Finished Dosage Products (FDP) and Active Pharmaceutical Ingredients (API) production.- Overseeing the release of incoming materials into production, including the development and approval of over 300 specifications and conducting more than 60 deviation investigations.- Facilitating the quality release of products to the market shortly after receiving approved Marketing Authorizations to meet commercial plans.Assessing and implementing changes, with involvement in over 10 change initiatives.- Managing Supplier's Quality Management processes, conducting qualifications for more than 50 suppliers.- Driving improvements in Quality Management System (QMS) processes workflow, including defining technical requirements for QMS modules and engaging with potential electronic systems suppliers.- Serving as a core team member for SAP Ariba implementation.- Leading SAP QM implementation for Inspection plans and Supplier Management modules, involving the collection, uploading, and verification of over 1000 master data objects.- Overseeing three international transfer projects focusing on Quality issues.Conducting internal and external audits, including participation in over 30 third-party audits and providing support during incoming regulatory audits.

Moscow Region, Russian Federation

Main responsibilities:- Development of specifications for API, starting materials, raw materials, intermediates, and finished products.- Ensuring compliance of raw materials and excipients for the production of sterile injectable Finished Dosage Products (FDP) and Active Pharmaceutical Ingredients (API).- Overseeing the release of incoming materials into production, including the development and approval of over 30 specifications.- For the list of more than 300 active suppliers: assessing, interacting with, and qualifying, including regulatory assessments, development of quality agreements, and managing Supplier Corrective Action Requests (SCARs).- Validation and verification of analytical procedures (over 30), providing support to the Quality Control (QC) lab on QA issues.- Conducting deviation investigations, developing Corrective and Preventive Actions (CAPAs), and performing Risk Assessments.Achievements:- Promoted to Quality Engineer within a year.

Moscow Region, Russian Federation

Main responsibilities:- Conducting Capillary Zone Electrophoresis for 3 products, Bacterial Endotoxins Assay for over 10 products, and ELISA using 2 techniques with Tecan reader and software.- Qualifying equipment, including 2 complex items and auxiliary instruments.- Managing laboratory supplies.- Developing and revising Standard Operating Procedures (SOPs), protocols, and normative documentation.- Conducting laboratory investigations of Out-of-Specification (OOS) deviations.Achievements:- Promoted to a Quality Assurance (QA) role within the company in just 6 months.

Yaroslavl, Russia

Main responsibilities:- Performing Quality Control (QC) of Monoclonal Antibodies (MABs) Finished Dosage Products (FDP) and Active Pharmaceutical Ingredients (API), utilizing all HPLC/UPLC techniques with Waters systems and Empower 3 software (over 10 methods).- Conducting ELISA techniques using SpectraMax reader and SoftMax Pro software.- Developing, implementing, validating, and qualifying analytical methods.Achievements:- Successful execution of 3 Analytical Transfer protocols.- Contribution to the development of over 10 Standard Operating Procedures (SOPs).

Tomsk, Russia

Main responsibilities:- Conducting electrophoresis and Polymerase Chain Reaction (PCR) analysis of DNA molecules, including Polyacrylamide Gel Electrophoresis (PAGE), Western blotting, and assessment of antimicrobial activity of recombinant proteins and peptides.- Performing Infrared (IR) and Ultraviolet (UV) spectroscopy analysis of biomolecules.Additional involvement:- Participation in scientific programs funded by the Russian Foundation:* 2015-2016 Russian Foundation for Basic Research (project No 14-04-31224) “Production of original nano-bio-complexes based on magnetic nanoparticles, functionalised by oligonucleotides and their properties studying in biosensors implementation”* 2014-2016 State Assignment (No 164/БУ-2015-360) “Realisation of applied research, including the pre-clinical studies of drugs and clinical trials of medicines. Obtaining of labeled supramolecular complexes for the detection of pathological states”;* 2014-2016 Russian Science Foundation (project No 14-15-00247) “Metabolic changes in the parasite-host interaction at the organ and organism level”.Achievements:- Contribution to 1 scientific publication.- Co-authorship of 1 patent.

Master'S Degree, Chemical Technology, 5 / 5

Diploma I degree, All-Russian final 74 student scientific conference. N.I. Pirogova, April 27-29, Tomsk, 2015 Diploma of the winner, III.

Associate'S Degree, Language Interpretation And Translation, Translator In The Field Of Professional Communication (English)

Activities and Societies: Scientific (chemistry, biotechnology) articles translation ENG-RUS and RUS-ENG. In-depth study of technical.

Bachelor'S Degree, Biotechnology, 4,964 / 5

Activities and Societies: Scholarship of the company "R-Pharm" from 2012 to 2014. Increased state academic scholarship in the nomination.