Project Manager Manufacturing

FELIPE A. ORTIZ

**** ** ***** ****** ( Miramar, FL 33027 786-***-**** (

abg6dc@r.postjobfree.com

Summary of Qualifications

Experienced, fully bilingual technical expert with eight years of

leadership and strategic business relationship skills. Capable of driving

productivity through the creation and implementation of strategies and

systems to generate measurable increases in efficiency and revenue.

Professional Experience

AZOPHARMA DRUG DEVELOPMENT SERVICES, LLC., Miramar, FL

SR. DIRECTOR, TECHNICAL CONTRACT MANAGEMENT, 2009 to 2010

Major Functions: Led the full integration of all elements of pharmaceutical

formulation development and manufacturing projects into cohesive and

compelling technical proposals/contracts, with a strategy focused on value

and scientific designs for clients.

. Developed complex technical-based proposals for virtual and small to

large pharmaceutical companies that accurately captured project timelines,

project cost, resources, and quality objectives. Efforts yielded more

than $15 million in awarded contracts in a period of 6 months.

. Established pricing by analyzing cross-functional activities against

client project and timing requirements; analyze bid strategy, ensure

profit margin, and negotiate terms and conditions that meet corporate

standards.

. Generated contract proposals within tight deadlines by working with

subject matter experts to develop approach towards a technical solution;

developing, refining, organizing and laying out key elements based on

client objectives.

. Discussed contract details with clients to ensure accurate understanding

of objectives, timelines; defended technical strategy to ensure scientific

and timely solutions that meet cost expectations.

SR. DIRECTOR, CLINICAL TRIAL MANUFACTURING, 2008 to 2009

Major Functions: Operations director responsible for developing,

implementing, and maintaining robust operation strategies for cGMP

manufacturing activities in more than 100 clinical trial manufacturing

campaigns.

. Ensured scheduling and performance criteria were met in a timely manner

by coordinating manufacturing activities with procurement and quality

assurance to assure optimum manufacturing capacity and use of personnel

and equipment resources for each project. Established troubleshooting

techniques and business relationships with vendors to ensure timely

solutions for technical obstacles that may have been encountered

throughout the manufacturing phase (i.e. equipment failures).

. Assembled high performing teams and mentored team leaders to achieve a

75% improvement in production schedule within 9 months.

. Ensured compliance with all applicable specifications, Standard Operating

Procedures, and FDA/EMEA regulations as per cGMP standards for Phase 1-3

clinical study materials.

. Regularly interacted with senior management to discuss productivity,

revenue, and strategies for increasing capacity and improving LEAN systems

that resulted in a 40% increase in divisional revenue.

. Responsible for the disposal of hazards materials and chemical waste

generated throughout the facility.

DIRECTOR, TECHNICAL BUSINESS OPERATIONS, 2007 to 2008

Major Functions: Primary liaison responsible for identifying prospective

clients and building global business relationships.

. Developed technical-based proposals identifying key areas within the

pharmaceutical and biotechnological industries; targeting under-developed

pipelines to increase productivity suitable to client objectives that

provided timely solutions meeting client expectations; yielding over $10-

million in awarded contracts over a 12 month period.

. Provided cross-functional project management and technical expertise in

pharmaceutical manufacturing to ensure accurate product development

strategies in support of over 50 pharmaceutical projects for ANDA, 505b,

505b(2), NDA and IND regulatory submission.

. Expanded global marketing for the company by developing business

relationships in Japan, Australia, Europe and South America through

corporate presentations and special topic courses at tradeshows and

workshops in support of marketing objectives.

SUPERNUS PHARMACEUTICAL INC., Rockville, MD

MANAGER, cGMP OPERATIONS, 2006 to 2007

Major Functions: Operations Manager responsible for organizing,

coordinating, and scheduling all activities in the GMP facility for

clinical trial manufacturing and supporting scale-up/demo batches.

. Successfully maintained cGMP equipment and facilities as per current

federal regulations. Implemented and maintained standard operating

procedures and good manufacturing practices training for all personnel

required to operate equipment in the development and operations area as

part of an ongoing educational training program.

. Served as in-house and outside safety consultant for facility,

manufacturing practices, equipment, lab safety and hazardous material

use/storage.

. Designed two additional manufacturing suites to expand the facility's

capacity to handle multiple manufacturing processes while effectively

using material, equipment and personnel to produce high outgoing quality

of all manufactured supplies while eliminating cross-contamination.

BIOMARIN PHARMACEUTICAL INC., Novato, CA

MANAGER, CONTRACT MANUFACTURING, 2005 to 2006

Major Functions: Project Manager responsible for the manufacturing of

Active Pharmaceutical Ingredients (API's) for the production of clinical

supplies for Orphan-based drug products and CMC-related activities.

. Responsibilities included managing and utilizing internal and/or external

resources to successfully supply clinical materials for ongoing double-

blind, dose-escalation multi-center Phase 1-3 clinical studies. Wrote and

reviewed analytical, process, stability and manufacturing sections of IND,

NDA and associated regulatory submissions.

. Led all CMC related activities at contract sites, including transferring,

implementing, validating, and monitoring of equipment and methodologies

throughout the product's process train.

. Organized, scheduled, and coordinated investigations and audits to

determine production and analytical problems. Identified and implemented

corrective actions to facilitate increase in process productivity and

capabilities to enhance cost efficiency.

CARDINAL HEALTH, Somerset, NJ

FORMULATION SCIENTIST (ORAL SOLIDS DEVELOPMENT), 2004 to 2005

Major Functions: Solved formulation and process development problems that

resulted in successful pilot-scale manufacturing of new pharmaceutical

products in support of Phase 1-2 clinical studies.

FMC BIOPOLYMER, Princeton, NJ

SENIOR RESEARCH TECHNICIAN, 2003 to 2004

Major Functions: Formulated experimental platforms using proven

technologies for the development of new products to establish relationships

with Latin American corporations to facilitate product confidence.

Education

CLEMSON UNIVERSITY, Clemson, SC FLORIDA ATLANTIC UNIVERSITY, Boca Raton,

FL

B.A. Chemistry and B.A. Spanish 2001 Lean Six Sigma Black Belt

Certification, 2011

Lean Six Sigma Green Belt Certified, 2010

Training

Sandler Sales Institute: Sales and Personal Development Program, 2010

Solid Dosage Training: Basic Formulation & Dry Granulation, 2006

Project Management for Technical Professionals, 2005

Barnett Educational Services: Designing and Applying Effective

Pharmaceuticals Binders, 2005

Colorcon Coating School, Powder Preparation and the Basics of Successful

Tablet Manufacturing, 2004

Felipe A. Ortiz Resume

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