Vladimir Wolf, Phd., Mba Email & Phone Number

Washington, Dc, Us

United States

Center for Devices and Radiological Health, Office of Health Technologies 7, Division of Microbiology Devices- Spearhead the division’s instrument software, ensuring compliance with regulatory standards and enhancing device reliability.- Lead the review process for electromagnetic compatibility and cybersecurity, mitigating risks and safeguarding patient data.- Direct the Medical Device Reporting (MDR) operations, coordinating postmarket surveillance activities to monitor device performance and patient safety.- Organize and train a dedicated team of MDR analysts, fostering a culture of excellence and continuous improvement within the division.

Usa , Slovakia

Driven by passion for BioTech. With business partner and friend Pavol Cekan, making the world better and healthier place. The "precision diagnostics" is the future of medicine. Thriving to make diagnostics more precise, accessible and affordable. Check out web page: http://www.multiplexdx.com.

Rockville, Md, U.S.A.

Trophogen Inc. is successful start-up in transition to market phase in the field of recombinant protein bio-betters (bio-superiors). I was in the key role wiithin regulatory and business activities in development of Trophogen's first product, resulting in Exclusive Global Veterinary License and Purchase Agreement With Zoetis, Inc.(read about it here: http://goo.gl/S5jzbZ) - Communication with FDA, INAD (animal IND) submission, preparations for NADA for Trophogen's new FSH drug. - Design of business strategy to break in to Veterinary drugs market. - Development of collaborations and strategic partnerships. - Development of business plan. - Improvement and optimization of web and social media presence.

Rockville, Md

Managing purification and formulation activities of recombinant FSH and TSH analogues. - Manager of Protein purification unit.- Developed processes of FSH and TSH production leading to technology transfer to CRO for GMP production.- Improved tracking of project deliverables.- Improved knowledge management through implementation of web 2.0 applications and increased firm's social media presence.

Germantown, Maryland

• Project lead on 4 projects, production of pre-clinical and clinical lots in GMP environment under FDA control.• Hands on experience and supervision of process transfer, forecasting, planning, ordering, raw material specifications sheet filling/QC, inventory, production MMR, QC, vialing. • Process development and product improvement: monoclonal antibody and alkaline phosphatase conjugation and purification, monoclonal antibody and carboxilated magnetic beads conjugation, RNA probe production.• Creation of Production documentation.• Documentation review and approval.• Coordinated groups Share-point activities.• Analyzed knowledge management practices as a part of MBA thesis project

Gaithersburg, Maryland

• Project lead on priority project: Implementation, Validation and Performance Qualification of new HPLC system into GMP production, supervision of junior scientists and associates. • Project lead on Scale-up of mAb/Alkaline Phosphatase conjugate production.• Technology transfer between R&D and Operations. • Scientific assistance to Operations activities.• Development of QC methods for conjugate production.• Guard banding and improvement of current conjugation processes.

Senior Scientist/Radiation Safety Officer/Information Technology - Mammalian protein expression, vector enginering, transfection, - cell types: 293, HEK, CHO, L cells, MDCK, E. colli- New Brunschwick bioreactor,- Protein purification: AKTA Purifier, AKTA Explorer- LC analysis: Agilent RP-HPLC,- computer hardwarwe and network maintnance- software instalation and maintnance

Bethesda, Md

- Investigated various biochemical and biological aspects of Wnt signaling pathway that resulted in number of publications.- Trained college interns and junior postdoctoral fellows.- Project lead: Expression and purification of recombinant secreted Frizzled Related Proteins, published in number of peer reviewed journals.- Established purification procedures of secreted Frizzled Related Proteins.- Designed an Sfrp-1 null mouse model that still appears in published studies.

Phd, Mammary Gland- Epithelia Apoptosis.

Activities and Societies: Institute for Cancer Research - Tiefenau USGEB, SSE

Mba, Business Integration

Activities and Societies: executive MBA programmGraduated December 18, 2010

Master Of Business Administration (Mba), International Residence Module On "Information Technology Services"

Mba, International Residence Module On Business Integration (Part Of University Of Wuerzburg' Mba Program

Ms, General Biology

Executive Mba

Master Of Business Administration - Mba, Business Integration