GMP Manufacturing Engineering

PHARMACEUTICAL / MEDICAL DEVICE MANUFACTURING & ENGINEERING

Accomplished professional with broad experience in providing technical

support of GMP manufacturing operations. High level understanding of

development and commercial manufacturing environments. Significant

experience in leading technical projects geared towards the launch of

commercial operations. Broad experience with day-to-day manufacturing

operations encompassing hands-on production assistance to engineering

support to quality systems related activities. Successful history of

developing and commissioning new manufacturing operations, specifying and

procuring process and packaging equipment, championing cost savings and

process improvement projects, and managing the overall corporate

engineering function. An effective communicator with excellent people and

project management skills. Expertise includes:

? Pharma / medical device manufacturing ? Pilot scale and

commercial manufacturing

? Equipment specification and procurement ? Design control

? Compliance to 21 CFR quality systems ? High level project

management

? Technology transfer ? Statistical process control

? Labeling and packaging ? Equipment qualification and process

validation

PROFESSIONAL EXPERIENCE

BIOCEPT, INC., SAN DIEGO, CA 2010 - Present

Director - Engineering

. Responsible for all engineering support related to R&D, Manufacturing,

and Facilities operations. Key duties include day-to-day

troubleshooting, management of capital equipment procurement

activities, tool/fixture design, facilities engineering, and

development of verification/validation test plans.

. Developed the Design Control documentation for Biocept's first

product. Convened a design control team to develop Design

Inputs/Outputs, completed Design Verification activities, including an

FMEA for the product, and gathered historical clinical data to

retroactively complete the Design Validation phase.

. Championed a design change in the company's primary product which

created an annual cost savings of $130K. Change involved fabricating a

key part via injection molding technology versus metal machining.

. Overhauled the manufacturing and laboratory operations in order to

improve operator safety and ergonomics. Among changes made were the

introduction of electronic filling dispensers to eliminate manual

filling, new work fixtures for better ergonomics, and completion of

time motion studies to identify bottlenecks and activities which

resulted in operator fatigue.

. Served as the Project Manager for the launch of the company's first

product. Utilized knowledge of Microsoft Project to develop the

overall project timeline. Used project management skills to

successfully guide the R&D, CLIA, and Operations teams to meet

established timelines.

. Managing the Packaging Engineering function. Successfully completed

the design and implementation of an insulated kit for the thermal

protection of blood sample tubes shipped from customers to Biocept.

. Supervising technical personnel comprised of manufacturing and

facilities engineers.

AUBREY INC., CARLSBAD, CA (Left As A Result Of Company Going Out Of

Business) 2009 -2010

Director - Engineering and Technical Services

. Responsible for engineering and project management functions

including: equipment procurement and troubleshooting, equipment and

process validations, design control process management, test methods

development, and maintenance of preventive maintenance and calibration

schedules.

. Spearheaded design control activities for Aubrey's primary artificial

wound dressing product, AWBAT . Responsibilities include management

and tracking of project timelines, scheduling of cross-functional team

meetings, and generation of meeting agendas/minutes.

. Specified, procured, installed and validated all equipment required to

address CE Mark audit observations. Equipment included a new heating

oven, automated spraying capability, redesigned work stations to

achieve consistency in raw material application, and revalidation of

an existing heat chamber to achieve controlled product drying.

. Successfully revalidated the spraying process to address CE Mark and

FDA audit observations.

. Designed, built, and validated physical test methods for in-process

and stability testing. These were part of the response to audit

observations.

. Spearheaded design control activities for Aubrey's primary product,

AWBAT . Responsibilities included management and tracking of project

timelines, scheduling of cross-functional team meetings, and

generation of meeting agendas/minutes.

CADENCE PHARMACEUTICALS, SAN DIEGO, CA 2006 - 2009

Associate Director - Chemistry, Manufacturing, and Controls (CMC)

Led technical responsibilities for the manufacture of Cadence's primary

product. Key accomplishments included:

. Management of an $8MM budget for the build-out and commissioning of

a new production facility at the company's contract manufacturing

organization (CMO). The project was completed in a compacted ten-

month period and consisted of a new Class 100/100,000 Fill/Finish

suite and packaging area.

. Management of the technical team responsible for the procurement of

the filling equipment (this was the most critical equipment in the

process). Direct involvement in the equipment design meetings, the

factory acceptance testing, the debugging activities at the CMO,

and the equipment qualification efforts. Displayed creativity and

resilience in successfully dealing with all issues impacting the

timeline.

. Success completion of the three registration batches required for

the NDA submission.

. Spearheading the site-to-site technology transfer program between

the drug originator's manufacturing site and the CMO. Among

activities transferred were the commercial manufacturing process,

the facility and equipment requirements, and all analytical test

methods.

. Management of procurement activities for the clinical trial

materials. Responsibilities included working closely with the

Clinical Operations Dept., developing a demand schedule,

spearheading clinical labeling/packaging activities, and managing

the clinical packaging organization.

. Completion of the CMC section of the NDA in an aggressive three-

month period. Worked closely with Cadence's Regulatory group in

completing this activity.

ELAN / DURA PHARMACEUTICALS, SAN DIEGO, CA 1998 - 2006

Senior Manager - Fill/Finish Manufacturing (Elan Pharmaceuticals) 2002 -

2006

. Led the technical oversight of Elan's contract-manufactured products.

Departmental charter included managing the CMOs to meet established

filling and packaging requirements. Dosage formats supported were

tablets, capsules, liquid parenterals, and blister packaging.

. Led the technical function in the successful launch of Prialt. Among

tasks completed were: joint development of the manufacturing process

with the CMO, technical review of all manufacturing equipment needed,

and auditing potential manufacturing sites.

. Managed the labeling and packaging engineering functions for contract-

manufactured products. Spearheaded various cost saving projects such

as the redesign of blister packaging to lower material costs, the

qualification of more economical shipping containers, and the design

of insulated shipper packouts to eliminate priority shipping needs.

Program Manager (Dura Pharmaceuticals) 2000 - 2002

. Led program management activities for the development of the Spiros

program, Dura's dry-powder inhaler device. Responsibilities included

development/monitoring of the project timeline, heading the technical

cross-functional team, and managing the relationship with Eli Lilly

counterparts.

. Managed a $4MM capital budget supporting the procurement of equipment

and completion of manufacturing facility improvements.

Manager - Industrial Engineering (Dura Pharmaceuticals) 1998 - 2000

. Led a team of engineers in the support of industrial and manufacturing

engineering functions. Main areas of responsibility included the

development of Elan's inhaler assembly operation, specification and

procurement of equipment, and installation/validation support.

. Generated capacity and process flow analyses, identified productivity

enhancements, created standard cost estimates, and analyzed man

power/resource requirements.

. Supervised a department of four engineers.

GENZYME CORPORATION, ALLSTON, MA 1996 - 1998

Senior Project Engineer

. Led Genzyme's Fill/Finish Engineering support function.

Accomplishments included the specification, procurement, installation,

and validation of process equipment needed for clinical and commercial

manufacturing. Among equipment procured were an automatic filling

line, a vial trayloader, and a terminal sterilization autoclave.

. Specified and procured a containment isolator for Genzyme's oncolytic

peptide program.

. Responsibilities covered day-to-day technical support of both clinical

and commercial manufacturing operations.

GENSIA-SICOR, IRVINE, CA 1993 - 1996

Lead Manufacturing Support Engineer

. Specified and procured a $1.5MM liquid parenteral filling line.

Equipment features included automatic checkweighing, CIP/SIP

technology, and SPC capability.

. Procured a $1MM automatic syringe filling line. The line was utilized

to fill Becton Dickinson HYPAK syringes.

. Supported day-to-day troubleshooting, process improvement, and cost

savings activities within the various manufacturing operations.

PROGRESSIVE POSITIONS OF RESPONSIBILITY AS DESIGN ENGINEER, 1987 - 1993

PROJECT ENGINEER, AND PRODUCTION SUPERVISOR

. Baxter Diagnostics, Miami, FL - Supervised a Filling Manufacturing

Department. Operation consisted of filling small volume parenterals

and supervision of twenty-five line operators. Responsible for the

management of a $700K budget.

. Baxter Diagnostics, Miami, FL - Led the timely completion,

installation, and validation of a $750K liquid filling line.

. Chase-Logeman Corporation, Hicksville, NY - Supervised the design and

fabrication of pharmaceutical filling and packaging equipment ranging

in value from $250K to $1.5MM.

EDUCATION AND TRAINING

MS, Industrial Engineering, University of Miami, Miami, FL

MBA, University of Miami, Miami, FL

BS, Mechanical Engineering, Rensselaer Polytechnic Institute, Troy, NY

Technical Certificate, Mechanical Design, Island Technical Institute,

Amityville, NY

LANGUAGES

Fluent in Spanish

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