Iryna D.
Director @ Pfizer
About
SUMMARY OF QUALIFICATIONS • PhD scientist with 14-year experience in biotech and Pharmaceutical industries • 13 years of hand-on experience of initiating, leading, and successfully completing scientific projects in support of biologics testing and manufacturing • Program management experience • Extensive experience working in a highly matrixed and geographically diverse business environment (large pharmaceutical companies, small biotech and start-ups, governmental and academic institutions, international and domestic clients) • Ability to communicate complex issues in a succinct and logical manner
United States
Ballwin
Pharmaceuticals
Molecular Biology, Project Management, Upstream Development, GMP, Lifesciences, Biotechnology, Genomics, qPCR, Cell Culture, DNA sequencing, Bioinformatics, Drug Discovery, SOP, Life Sciences, In Vivo, In Vitro, Genetics, CRO, Laboratory, Drug Development
Experience

Principal Scientist/Pharmaceutical Science Team Leader
St. Louis , MO
• Lead project teams, drive overall project strategy and develop execution plan for the assigned projects (gene therapy, immunotherapy, monoclonal antibodies, etc.) • Ensure timely development of project timelines, resource forecasts, annual budgets, and related deliverables for the assigned projects • Work with key stakeholders across commercial, clinical and Pfizer Global Supplies (PGS) to define the product concept and lead the operational planning for assigned projects • Interface with Drug Safety, Dev Ops, Global Supply Chain, and Clinical to develop a clinical supply and administration strategy • Act as an ambassador to project team leaders, governance bodies and other key stakeholders • Align plans between Pharmaceutical Sciences and other Lines or Therapeutic Area Strategies • Act as a subject matter expert • Participate in strategic leadership and portfolio meetings as Pharmaceutical Sciences representative

Faculty
University of Phoenix Philadelphia Campus
• Facilitate courses in nutrition, biology, environmental sciences • Provide instructions, assessment, and supervision of the students' progress • Motivate students to actively participate in all aspects of the educational process • Participate in school retention initiatives by providing regular, accurate, and timely feedback to students and the school concerning academics, behavior, attendance, etc.

Senior Scientist, Process Development and Commercialization
Greater Philadelphia Area
• Lead a core team to develop WuXi platforms (adherent and suspension cell lines, AAV and Lentivirus) • Identify program risks, develop and implement mitigation strategies for platforms • Execute integrated plans leading to the successful development of platforms • Facilitate and drive meetings effectively and clearly communicate decisions related to platform development and implementation • Update senior management on key program milestones • Manage team resources, lead PD forecasting and capacity planning activities • Create platform budgets, batch records, SOPs, report templates

Process Development Scientist/Project Lead
Greater Philadelphia Area
• Manage all activities required for successful operation of assigned project: design experiments, write protocols, coordinate activities in the laboratory, develop Bill of Materials (BOM), execute and document experimental studies according to SOPs, review and report data, and create technical reports • Develop bioanalytical assays in support of process development and manufacturing activities • Develop process development strategies • Apply understanding of regulatory expectations to define process development strategies • Contribute to process risk assessments to justify development strategies and experiment designs • Interact with internal (Manufacturing, Engineering, Facilities, Validation, Quality Assurance, Quality Control, Project Management, and Materials Management) and external (clients, material/equipment vendors and commercial partners) customers Expertise: Upstream and downstream process development (early and late stage development), analytical and molecular assay development and validation (immunological assays, qPCR, ELISA, enzyme activity assays, etc.), data analysis, tech transfer, risk management.

Scientist/Study Director/Supervisor
• Act as a Lab Manager or Principal Scientist in Molecular Biology department • Manage day-to-day aspects of sequencing laboratory operations (pipeline improvement, staff engagement and scheduling) • Design, execute assays and interpret data • Provide strong technical support and trouble shooting for custom studies • Review Batch Records, SOPs and data quality • Investigate noncompliance events, implement CAPA • Create testing proposals for regulatory submissions (IND, BLA) • Schedule and participate in teleconferences, provide minutes, interact with clients, subcontractors and project managers/account managers to address scientific and related issues • Manage project scopes, changes, deliverables • Create protocols and technical documentation • Supervise staff • Research and launched new services • Present Molecular Services at sales meeting, conferences, vendor exhibitions Expertise: Molecular Techniques (qPCR, Sanger and next Generation sequencing, DNA fingerprinting, cloning), DNA/RNA isolation (blood, tissues, cell culture), cell culture (eukaryotic/prokaryotic), project management, GLP/GMP, assay development/validation/qualification, tech transfer, staff supervision, technical documentation, project deliverables monitoring

Postdoctoral Fellow
Major achievements: • Developed the recombinant viruses to visualize the herpes infection • Collaborated in making these viruses useful for the anti-tumor gene therapy • Analyzed the association of histons with herpes virus during infection • Initiated a project potentially leading to the development of the anti herpetic treatment Expertise: Virology, Molecular Biology, transfection, infection, microscopy, cell culture, qPCR, presentations, collaboration

Research Assistant
Major achievements: Completed Medicago truncatula chromosome I sequencing • Completed soybean seed BAC sequencing • Proved the existence of gene duplicates and clusters in legumes at the whole genome level • Demonstrated the difference in expression profiles of primary and secondary metabolic genes • Contributed to 454 Roche pyrosequencing protocol optimization • Trained three undergraduate students in genomics and bioinformatics and led their senior and honor thesis completion Expertise: Sanger and 454 sequencing, standard Molecular Biology techniques, protein purification and expression, bioinformatics
Iryna D.'s Contact Information
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