Engineer Process
Resume:
Profile
Experienced Process Development Engineer with a proven track record of
reliability, integrity, interpersonal skills and innovative ideas, who
thrives in fast-paced, challenging environments. Expertise in process
development in both the pharmaceutical & biotechnology industry. Skills
include project management, concept development, process improvement,
stastical analysis and commercial scale up. Additional skills include
knowledge of current federal guidelines, FDA/USDA/EMEA/PMDA regulations,
SOP preparation, and streamlining of procedures. Versed in Minitab, JMP,
Trackwise and Oracle. Working knowledge of Spanish.
Skills Summary
Design of Experiment IP Generation
Strategy Planning & Implementation Technical Writing
Concept Development Regulatory Strategies
Technology Transfer FDA Compliance
Statistical Analysis GMP/GCP/GLP Compliance
Process Improvement, Simulation, Research & Development
Scale-Up and Validation Project Management
Professional Experience
Process development Engineer II - lifecell corporation
NOVEMBER 2010 - JANUARY 2014
o Designed and developed processes for manufacturing clinical and
commercial tissue products, using statistics based experimentation
and principles of process excellence.
o Developed custom pilot scale and manufacturing equipment; develops
and implements plans for IQ, OQ and PQ of the equipment with
validation.
o Wrote batch records, standard operating procedures, protocols, and
reports for feasibility studies, method validations and stability
studies.
o Planned and executed validation studies and participated on various
problem solving committees.
o Worked closely with Manufacturing Engineering & Operations
Engineering to implement new technology and processes into
Production.
o Maintained knowledge of current production process and problem areas
to better design transfer processes and review regulatory filings
accurately.
o Partnered with the additional product support team representatives
such as QA and Regulatory to ensure process compliance and seamless
transfers.
o Conducted verification and validation studies to demonstrate the
ability of the product/device to function as intended.
o Provided the necessary documentation to support regulatory filings
such as design dossiers, 510(k), and PMAs as required.
o Set-up pilot scale manufacturing processes for making clinical
supplies under GMP conditions. Worked with in-house groups and
vendors to ensure compliance of the facility.
o Provided statistical analyses to set product specifications and
expiration dates.
Process development senior associate - imclone systems, a wholly-owned
subsidiary of Eli Lilly and Company
MAY 2009 - NOVEMBER 2010
o Provided guidance and training to junior level associates.
o Independently performed process optimization studies to support the
work of Senior and Staff Scientists.
o Developed and spearheaded the installation of a new HPLC system for
titer measurements.
Process development associate - imclone systems, a wholly-owned subsidiary
of Eli Lilly and Company
MAY 2007 - MAY 2009
o Provided support for existing Clinical Manufacturing processes and
assist in planning and execution for the development of new upstream
developmental processes using small-scale model systems.
o Performed optimization studies of media, feeds and bioprocess
conditions.
o Produced toxicology lots for pre-clinical studies in support of
ImClone's pipeline products.
o Provided support for technology transfers to internal manufacturing
groups (Clinical and Commercial).
o Performed small-scale process validation (range evaluation) studies.
o Assisted in the development of production procedures to optimize
manufacturing and/or regulatory requirements.
o Researched new technologies and procedures to enhance production.
o Maintained accurate notebook, logbooks, protocols and reports to
support Regulatory filings.
o Participated and performed in accordance with company, department
and cGMP training.
Education
The johns hopkins university - baltimore, MD
M.S - BIOTECHNOLOGY
Graduation Date: 05/2012
Montclair state university - Upper Montclair, NJ
B.S. - MOLECULAR BIOLOGY, MINOR IN CHEMISTRY
Graduation Date: 05/2007
Certifications/Memberships
Associations For the Advancement of Medical Instrumentation: Design
Control Requirements and Industry Practice.
Member - American Society for Quality
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