Project Manager Quality Assurance

*

EDWIN ROMAN PAGAN

Career Profile

Talented Manufacturing and Laboratory leader with a diverse experience in

MFG Management and Projects, Quality Control and Floor Execution. Leader

for Manufacturing Operations with comprehensive experience on investigation

and continue improvements within company projects and initiatives.

Believer on a team work enviroments. Demonstrate leadership, analytical

and interpersonal skills. Experience in hire, train and develop people.

Proficent in computarize systems, such as: LIMS, TRACKWISE AND SAP.

Key Capabilities & Competencies

- Team Worker - Leadership - Managing people

and team motivation

- People skills - Laboratory skills - Continious

improvement strategic thinker

- Self Starter - Adaptability - Enviromental &

Safety Sponsor

Achievements

. Operations Start-up for API Biotech Bulk Manufacturing as MFG

Supervisor

. Lean Manufacturing - Six Sigma Yellow Belt

. Ideas and Improvements Management Implementation (Operational

Excellence Kick-off Team member for Bulk MFG)

. Increase Production Run Rate for API Batches (Bulk MFG)

. Environmental and Safety (ESMR) Program implentations

. Project Specialist liason with Technical Services Department in the

Project Implementation for Manufacturing (Protein Target

Concentration, Chromatography Column Regeneration)

. Electronic Batch Records (EBR) execution and implementation team

member

. Laboratory Chemist Key Player in the Total Organic Carbon (TOC) new

method introduction

. New hire recruitments, prepare training materials, train and instruct

staff in the implementation of new operations MFG Technology

Professional Experience

Manufacturing Manager (FLM) Novartis Humacao (January 2013- present)

Lead and Supervise operations for the manufacturing of oral solid dosage.

Overview Manufacturing includes operations for raw materials weighting,

mixing/granulation, compression and coating. Daily activities include but

not limited to Production schedule adherance, address and resolution of

area needs, mechanical interventions, facility improvements and Batch

record review. Hire staff and address diciplinary actions each individual

case with HR Dept. Develop strategies for production building-up and

introduce and raise motivation elements within the team.

Manufacturing Project Specialist for Fill & Finish Facility Amgen MFG

Juncos (Dec 2011 - Apr 2012)

Project Manager for Drug Product Formulation Area. Manage Quality

Improvements as project "Steam Sterilization". Improve SIP conditions for

tanks and transfer lines. Project Plan development, Multidisciplinary

Staff Reporting to me from Process Development, Validation, Quality and

Engeeniring Department. Up-dates reporting to Directors and Senior

Management.

Manufacturing Manager for Fill & Finish Formulation (December 2009 -

December 2011)

Leader and responsible for the Drug Product Formulation. Areas of

responsibility include: Dispensing (Material Dispensing), Component Tank

preparation (CIP/SIP - Fix and Portable), in process laboratory and Drug

Product Formulation. Formulation performed as Buffer preparation/Drug

Product Mixings and UF/DF Technology. In Process Buffer and Intermediates

Quality Assurance by Analitical Testing as pH, Conductivity and Protein

Concentration. Coordinate operation to adhere schedule completion. Assist

production issues, troubleshooting,schedule, audits and improvements.

Ensure production records are in compliance. Provide "coaching" to area

personnel for individual's developments and recognitions, contribution and

conflict resolutions. Write and discuss performance review and disciplinary

actions. Support initiatives from the Operational Excellence program

(continues improvement) program. Lean-Six Sigma Yellow Belt.

Apartado 1681

Luquillo, Puerto Rico 00773

Phone: 787-***-****

email: *******@*****.***

EDWIN ROMAN PAGAN

Manufacturing Process Owner Manager for Drug Substance API (December 2007 -

December 2009)

Leader of a Technical and Specialist Team (Multidiciplnary Team) to kick

off operational excellence programs at the Protein Purification Operations.

Execute manufacturing improvements for system as: Colums chromatography,

homogenizers, centrifuges, drug substance solubilization and UF/DF.

Recommend improvement driven by Process Risk, Product Quality and Cost

Reduction.

Manufacturing Supervisor for Drug Substance (API) (May 2003 - December

2007)

"Start Up", Manage and develop a new Manufacturing Team for a new

technology transfer- Protein Purification Manufacturing. Train and develop

a new e team on systems as: Ion and Batch Chromatographies, Product

transfer by pressure/pumps, product filtration, chemical reaction (RX),

UF/DF and tanks CIP and SIP. Hire and recruitment, prepare training

materials, train and instruct staff in new technology. Evaluate, revise and

approve reports, protocols and procedures. Ensure production schedule are

follow and the GMP compliance of operating areas. Participate on the

equipment validation and assist on the daily issues. Lead and implement the

EH&S plan. Lead floor batch record review readiness team. Perform staff

meeting, up-dates metrics and support schedule strategies to comply with

production run rates. Provide "coaching" to area personnel for individual's

developments and recognitions, contribution and disciplinary/conflict

resolutions. Participate in a multidisciplinary (QC/QA, Validation, PD,

Technical Services, HR, Supply Chain) team for issues resolutions.

Laboratory Senior Lead Chemist, Schering Plough, Las Piedras, PR (2001-

2003)

Essential Duties and Responsibilities were, but not limited, to: Assist

Laboratory Supervisor in Projects, Schedules, Audits, and complete Special

Request to assure compliance of the Quality Operation Laboratory. Test Raw

Materials according to USP/NF, EP, JP and Internal General Testing

Standard. Calibrate and Operate analytical instruments. Coordinate

Laboratory flow schedules in order to comply with Manufacturing and Company

goals. Issue and document Laboratory Investigation Reports (LAR). Conduct

Analyst and instruments Qualifications. Write, revise and correct

Laboratory Standard Operating Procedures (SOP's).

US Naval Station Roosevelt Roads, Ceiba, Puerto Rico.

Enviromental Laboratory Chemist (April 1999 - October 2001)

Responsible for the compliance of the Environmental WWTP Laboratory

Operations. Perform chemical-environmental analysis as BOD, COD, Oil &

Grease, Metals & Inorganic compounds according to (Environmental Standards

Methodology). Conduct Laboratory Operations and Programs as laboratory

instruments calibrations and files, Quality Assurance Reports, Safety

Respond EPA Audits programs under discharge monitoring report as part of an

NPDES EPA permit.

QC Analyst, Bristol - Myers Squibb, Humacao, PR (1996-1999)

Perform Chemical Analysis for Raw Materials, Intermediates, and Packaging

Components and finish product samples, using different methods and chemical

techniques (USP/NF, EP, BP, and Generals Testing Standards). Able to run

rotating shift in order to give support to the chemical bulk plant

(intermediates process). Perform Laboratory data verification.

Apartado 1681

Luquillo, Puerto Rico 00773

Phone: 787-***-**** / 355-0416

email: *******@*****.***

Apartado 1681

Luquillo, Puerto Rico 00773

Phone: 787-***-**** / 355-0416

email: *******@*****.***

EDWIN ROMAN PAGAN

[pic]

University of Puerto Rico, Humacao Campus. Research Technician (August

1994 - April 1996)

"Synthesis and Laser Flash Photochemistry of Promazine Derivatives". Ph.D.

C. Garc a / PH J. Su rez

- Perform synthesis of Organic Compound and the characterization by

IR, TLC, GC/MS and NMR.

- Product solubulization and extractions

- Daily work include organic techniques, library search and computers

literacy.

Education

- MBA Management (Expected May 2014)

- BS Industrial Chemistry, University of Puerto Rico (May 1996)

- Biotechnoly Certification, University of Puerto Rico (June 2003)

- Protein Purification/Downstream Processing, Massachussett Institute

of Technology (April 2007)

PERSONAL INFORMATION

- PR Department of State License Chemist LIC. 4275

- Downstream Processing Training- MIT (Massachusetts Institute of

Technology, USA)

- Manufacturing Biotech Curriculum Training at University of Puerto

Rico (Mayaguez, PR)

- Biotechnology Bulk MFG -Job Shadowing Training (California, USA)

- Automation-Development Test Project at Rockwell Automation

(Arizona, USA)

- Agilent -HP Gas Chromatography 6890 ( Atlanta, USA)

- Approved Training NIRS-Near Infrared (Maryland, USA)

- RS Batch Management Automation Training (Caguas, PR)

- Puerto Rico Department of Health- Food Inoculum Regulated Course

- Able to travel & be relocated

Contact this candidate