Summary

My six years of solid leadership experience, with proven ability in managing pro
ject teams, leading execution and strategy plans for new product introductions a
nd financial and risk management analysis are skills I would like your team to c
onsider in this management placement. Currently as the Drug Product Technical La
unch Integrator for Janssen Pharmaceuticals of J&J, I have established strategic
processes to proactively manage product introduction via collaboration and nego
tiation with cross regional business partners, resulting in successful product l
aunches for the company.
Education
Boston University ? Metropolitan College, Boston, MA (September 2009 -
Present)
? Master of Science in Banking and Financial Services Management
Expected Graduation date: Spring 2011.
Georgia Institute of Technology ? Atlanta, Georgia (August 1999 ? Decem
ber 2003)
? BS in Mechanical Engineering
Dean?s List ? Fall 2002
Tower Award Recipient ? Bronze Yearly Award
Experience
Janssen Ortho, LLC ? Gurabo, PR (May 2010 ? Present)
New Products - Drug Product Technical Launch Integrator
? Responsible for the technical and manufacturing integration of new and re-deve
loped Drug Product and Drug Substance from PDMS into the Supply Chain. Partnered
with the PDMS and Supply Chain groups to develop and implement strategies to im
prove the fit for plant and commercialization of new products into the Supply Ch
ain.
? Develop the manufacturing site execution plan per product, in line with the ov
erall strategy and plan as outlined by the CMC DPD Sub-team and GPSG New Product
Team.
? Drive and assure manufacturing site readiness and execution in partnership wit
h the site functions and management, supply chain technical functions (platforms
/engineering), DPD TI, NPL, and DP TLI functional lead and SME?s.
? Deliver clinical through commercial DP supply from the manufacturing site, mee
ting manufacturing performance, cost, and process robustness requirements, in li
ne with QbD principles and supply chain performance metrics.
? Manage the planning and execution of DP TLI and manufacturing site project del
iverables ensuring delivery of agreed milestones and objectives.
? Coordinate and execute product introduction along the project continuum from D
P transfer through launch covering raw materials, formula, process, packaging an
d device integration into the finished DP and supporting the NPL for site relate
d launch activities.
? Identify and implement opportunities for active decrease in COGS.
Janssen-Ortho, LLC ? Gurabo, PR (May 2008 ? May 2010)
TRF Tapentadol Manufacturing Supervisor
? Manufacturing lead of the Tamper Resistant Formulation (TRF) Tapentadol operat
ions, leading to FDA manufacturing site approval with zero observations.
? Managed the manufacturing activities related to the new Tamper Resistant Formu
lation (TRF) Tapentadol Process Tech Transfer into the Janssen-Ortho, LLC Gurabo
manufacturing facilities meeting strict timelines for Site Stability, Pre-Verif
ication and Clinical Manufacturing Supplies activities. Tasks included day-to-da
y monitoring of manufacturing floor execution, resource coordination, schedule p
lanning and cGMP quality compliant batches.
? Developed Standard Operating Procedure, identified opportunities for minimizin
g downtime and developed capacity forecasts for future expansion of the TRF manu
facturing area.
 Janssen-Cilag, LLC ? Gurabo, PR (August 2007 ? April 2008)
OROS Manufacturing Supervisor
? Responsible for the day-to-day running of the OROS processes, which included g
ranulation, compression, aqueous and solvent coating, laser drilling, tray dryin
g and printing. This included tactical planning as to assure all centers are run
ning and that WIP is available for continuous flow.
? Maximized equipment run time by coordinating activities and getting resolution
of events that are affecting operation of the area.
? Met production targets for the developmental and validation exercises for INVE
GA* and CONCERTA* registration batches.
? Supervised operators involved and engaged in the production activities for the
developmental and validation exercises for INVEGA* and CONCERTA* registration b
atches. Task included overtime coordination, resource allocation for continuous
process flow and schedule planning.
Janssen-Cilag, LLC ? Gurabo, PR (August 2006 ? August 2007)
Project Parent
Utilities & Maintenance Supervisor
? Supervised and coordinated activities engaged in maintaining building utility
systems, such as electrical wiring and control systems, heating, ventilating, wa
ter supply, steam generating, and related pipe systems for Janssen Cilag, LLC Pa
renteral facility at Gurabo, PR. Maintenance and coordination efforts also inclu
de process utilities systems such as RO Generation, WFI, and Clean Steam Generat
ion.
? Provided support in the Building Automation System (BAS) and Process Utilities
System (PUS) implementation and commissioning phases for Project Parent, a gree
n project of around +$150MM.
? Inspected systems to determine preventative maintenance and spare part needs.
? Provided full engineering support to the commissioning phase of all building a
nd process utilities.
? Supervised workers engaged in maintaining and repairing processing equipment a
nd machinery.
? Performed Safety & Environmental assessments to all utility equipments and imp
lement recommendations.
? Developed and implemented Standard Operating Procedures for all plant and clea
n utilities.
Janssen-Ortho, LLC ? Gurabo, PR (January 2006 ? August 2006)
Project Parent
Co-Generation Project Engineer
? Worked as project engineer in the design and installation of a $6.0MM cogenera
tion plant to supply primary power to the new sterile filling/lyophilization fac
ility to be based in Gurabo, Puerto Rico.
? Managed the budget, design development, equipment procurement, installation an
d commissioning for the cogeneration plant.
McNeil Consumer & Specialty Pharmaceutical, Las Piedras, PR (May 2005 ? December
2005)
Utilities Project Engineer
? Developed and executed Energy Star Projects directed towards energy conservati
on and management, such as the installation of Soft Starters for 125 HP Super E
Premium Efficiency Motors reducing energy costs in around +%10 per year.
? Managed HVAC system modification projects, such as air ducts modifications, eq
uipment installation and air balancing adjustments which resulted in higher syst
em efficiency of up to 5%.
? Electrical Sub-station 38kV Protection Circuit Breaker Project. Developed capi
tal budget, involved in the electrical design, contractor bidding process and eq
uipment installation. Coordination of electrical shutdown for breaker rigging an
d controls connection activities.
Ortho Pharmaceutical, Inc., Manati, PR (February 2004 ? April 2005)
Process Engineer
? Involved in the qualification and validation of process equipment such as Garv
ens Checkweighers and IWKA Tube Filler and Induction Heating Radio Frequency Gen
erator.
? Lead engineer in the Manufacturing Pre-weigh Scales Standardization Project. T
he Scale Standardization Project included Cost Avoidance benefits mostly from: O
n-site technical knowledge/expertise for equipment support, spare parts standard
ization for all rooms, savings in external support cost due to equipment standar
dization, full compliance, response and closure to MAP issues, and batch loss av
oidance.
? Participated in the new Retin-A-Micro Metered Dose Bottle Presentation Project
. Developed the Capital Appropriation request and engineering equipment assessme
nts.
? Lead Engineer for the Module C Chilled and Hot water Utilities Refurbishment P
roject. Developed project budget, change control documentation, commissioning of
the Module C utilities system including pipes and valves installation.
Skills
? PM Certification in progress.
? Computer knowledge: MS Office, AutoCAD, Minitab, and Engineering Equation Solv
er.
? Certificate of Accomplishment: Pharmaceutical Facility Utilities: Design, Vali
dation and Operation.
? Trained in cGMP Regulations.
? SAP knowledge.
? Fully bilingual (English and Spanish), proficient in Italian language.
? Self-motivated and teamwork oriented.
? Work well under pressure, good networking skills.
? Italian citizenship. (European Community).
Leadership
* J&J Engineering Leadership Development Program (ELDP)
Member of the 2004 ELDP class: This program is dedicated to promote technical ex
cellence and business leadership through a structured two-year period of orienta
tion and development in traditional classroom training, job rotations, and perso
nal mentoring for top engineering graduates.
* Janssen Ortho, LLC - Employee of the Year 2009 - 2010