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SKILLS Manufacturing: Cell Culture (MRC-5, HUT-78 infected with HIV-1), Ultrafiltration, Diafiltration (Pellicon), Chromatography (AKTA, K-Prime, ion exchange, gel filtration and hydrophobic interaction), Filling, CIP, SIP, Aseptic Technique
Analytical: HPLC analysis of viral proteins (Agillent 1200 series using ChemStation), ELISA (p24) on Vmax plate reader using Softmax Pro software, Total Protein and Host Cell Protein Assay, SDS Page, Western Blot
EXPERIENCE The Immune Response Corporation (2006-Present)
05/06-Present Process Scientist: Design and optimize scalable processes for the manufacture of preventative and therapeutic HIV and Multiple Sclerosis Vaccines. Participate in all aspects of the manufacture and release of product to be used in clinical trials.
· Optimized the purification of HIV-1 antigen by developing a one step chromatography process while increasing virus recovery.
· Developed multiple purification methods with AKTA systems and performed scale up operations with a Millipore K-Prime II chromatography system.
· Characterized purified HIV antigen by HPLC, ELISA, SDS PAGE, and Western Blot.
· Contributed to the development of a chemically defined serum-free cell culture medium. Performed scale up operations in a Wave bioreactor, 100 Liter and 250 liter custom bioreactor tanks.
Merck and Co., Inc. (2003-2006)
03/03-05/06 Process Supervisor, Varicella Bulk Manufacturing: Directly supervise the large-scale cell expansion and virus infection process for VARVIAX ®. Oversee and troubleshoot the setup and operation of 10 automated cell culture robots, CIP and SIP processes and media formulation. Investigate Process deviations and implement process improvements. Directly supervise 60 union bio-technicians.
· Participated in multiple inspections by CBER and foreign government regulatory agencies.
· Coordinated the shutdown and preventive maintenance of all HVAC systems and HEPA filter certifications.
· Participated in the potency investigation team and initiated a project to increase the robot cycle time during viral propagation in order to directly control production bottle harvest time.
· Led the IQ/OQ of performance upgrades to 10 automated cell culture robots.
· Earned Award of Excellence for leading the department in the manufacture of the Varicella Stock Seed.
· Planned and executed the production of an increased lot size for Varicella Bulk, increasing bulk inventory by 20% annually.
· Reduced the amount of sterile glassware required for biological waste inactivation saving $300,000 annually.
· Planned and executed all aspects of 6 cell expansion and viral propagation bulk media challenges
· Participated in a process deviation reduction team, reducing human error deviations by 10%.
SKILLS Manufacturing: Cell Culture (MRC-5, HUT-78 infected with HIV-1), Ultrafiltration, Diafiltration (Pellicon), Chromatography (AKTA, K-Prime, ion exchange, gel filtration and hydrophobic interaction), Filling, CIP, SIP, Aseptic Technique
Analytical: HPLC analysis of viral proteins (Agillent 1200 series using ChemStation), ELISA (p24) on Vmax plate reader using Softmax Pro software, Total Protein and Host Cell Protein Assay, SDS Page, Western Blot
RELAVENT COURSES Scale up and Practical Aspects of Chromatography, EMD Chemicals
Project Management, Penn State University
MILITARY EXPERIENCE U.S. Army-Captain-Infantry/Signal Corp (1999-2003)
Schools: Ranger School, Airborne School, Signal Officer Basic Course Infantry Officer Basic Course.
7/00-03/03 Battalion Signal Officer: Supervised, mentored and trained 13 information systems and
communications specialists. Designed, managed and supported all automation, communication
equipment and information processing systems in a 1,000-person organization with the mission of
deploying to any area of conflict within 72 Hours.
1/99-7/00 Rifle Platoon Leader: Directed the training, discipline, maintenance and logistics of a 40 person
tactical unit with the mission of being worldwide deployable to any area of conflict within 72 hours.
Responsible for the maintenance and accountability of 4 heavy track vehicles and their associated
weapons and equipment valued over $10,000,000.
EDUCATION BS - Biology - State University of New York at Binghamton - 1998
· James D. Grierson Memorial Award for Excellence in Botany
· Phi-Theta-Kappa Honor Society
· ROTC Scholarship Winner