Project Management
Resume:
Sunil Daniel
Cleveland Heights, OH 44118
*****.*.******@*****.***
Work and Research Experience
Associate Process Engineer at Boehringer Ingelheim - Ben Venue Laboratories
(August 2011-Present)
Supported innovative efforts to identify, evaluate and implement new
technologies that will improve the quality and cost efficiency of
parenteral manufacturing operations and processes. Experienced in
IQ/OQ/PQ.
Team leader for Technology Transfer of products and processes to a new
facility.
Led and participated in cross functional team to address site-critical
issues in the manufacturing process. Performed root cause analysis and
instituted CAPAs that resulted in manufacturing of product on the FDA
drug shortage list. Received Excellence in Action award for
contributions.
Provided engineering technical support and project management for
problems and projects related to small through full scale manufacturing
operations, environmental containment, facilities design, personnel and
facility safety, and regulatory issues.
Managed large scale capital projects upwards of $500,000 to ensure the
Pilot Plant will be able to support the development and transfer of new
products and processes.
Developed protocols, reports, batch records, procedures, critical
process parameter justifications, risk assessments, and project
schedules to ensure successful project execution.
Experienced with Formulation, Filling, and Lyophilization techniques, as
well as production and bench-scale equipment such as Freeze Dryers,
Autoclaves, Hot Air Ovens, Data loggers, etc.
Adjustable gastric banding system design in conjunction with Ethicon Endo-
Surgery (August 2007-June 2008)
Revised designs of current bands on the market, re-designed the band
which exists in the current market to offer two initial sizing options
and which also includes an internalized pump to vary band diameter in
vivo. Became well versed in FDA regulations, documentation, and
financial statements. Experience with DHF, DMR, and DHR requirements.
Research Assistant for Investigating Role of Shp protein in targeting
Cancer cells (May 2007-August 2007)
Synthesized and purified Shp protein for Case Western Reserve University
Biochemistry department study.
Learned lab practices such as X-ray Crystallography, HPLC, Gel-
Electrophoresis, PCR, Gas Chromatography, IR Spectroscopy, etc. Worked
without supervision and was able to learn on the job while meeting each
deadline.
Skills and Specialties
. Process Improvement
. cGMP
. Lean Six Sigma
. Change Control
. Technology Transfer
. CAPAs
. Project Management
. Commissioning/Qualification
. Lyophilization
. Matlab, Solidworks, AutoCAD
. FMEA
. Compliance Regulations
Other Experience
Co-Chair of City Year Cleveland Alumni Board and former City Year Corps
Member (August 2009-Present)
. Lead City Year Cleveland Alumni Advisory Board to plan activities that
mobilizes alumni as volunteers, donors, and ambassadors of City Year
. Support City Year corps members along their leadership path
. Connect the diverse City Year Alumni Community
. Advance City Year's service and national service movement
Co-Founder and Board Member of The STRIDE Charitable Fund, Inc.
(December 2004-December 2010)
. Co-created non-profit organization to send medical research technology
for research related to monitoring and treatment of infectious disease
to developing world. Programs approved by the World Health Organization.
Education
Case Western Reserve University
(August 2004-May 2008)
. Bachelor of Science in Biomedical Engineering with concentration in
Economics.
Colorado Technical University
(September 2008 - January 2010)
. Executive Master of Business Administration degree completed in January
2010. Includes certificates in Business Administration, Business
Management and Change Management.
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