Development Medical Device

Prapaporn Kulphaisal

**** ***** **** *** # ** Tel: 408-***-****

Santa Clara, CA 95051 Email: ***********@*******.***

PROFILE

Experienced science professional with over eight years experience in

pharmaceutical industries for sterile and non-sterile products. Experience

and hands on knowledge of raw material, drug, device, and combination

product analytical testing, ensuring compliance to domestic and

international regulations. Well versed in Product Development and Quality

Systems.

TECHNICAL AND SPECIAL SKILLS

. Quality: Inspection and analysis of materials and final products. CAPA

investigation. Internal and supplier audit. GMP documentation review.

. Analytical: Equipment and test method IQ/OQ/PQ validations, technical

transfers, and stability programs.

. Product Development: Methodology and Analytical Development for early

stage instrumentation, APIs, excipients, device, and combination

products.

Professional Experience

Assistant Manager, Quality

2008 - 2011

A.N.B. Laboratories Co., LTD.

Bangkok, Thailand

. Identified, scheduled, and performed systematic corrective and preventive

action (CAPA) activities.

. Participated in risk management review and customer complaint

investigation

. Reviewed and approved SOPs, Test Methods, and other controlled

documentation to ensure laboratory data integrity and traceability.

. Conducted investigations into deviations, out-of-specifications, and non-

conforming issues related to Quality.

. Assisted with the implementation of validation procedures and calibration

scheduling on GMP analytical instruments.

. Assisted with domestic and international regulatory agency inspections.

. Member of company's ISO steering committee, which performed annual

internal audits of the sterile and non-sterile manufacturing facilities

to ensure cGxP compliance.

. Managed the inspection and analytical operations of raw materials,

packaging materials, intermediate products, and finished products.

. Proactively participated in continuous process improvement activities for

departmental and cross-functional levels.

. Reviewed qualification, validation, and regulatory compliance

documentation.

. Served as a liaison to management in addressing concerns related to error

trends and problem areas.

Associate Scientist

2006 - 2008

Nektar Therapeutics

San Carlos, CA

. Led projects in aerosol research and other analytical scientific product

development activities to meet regulatory requirements.

. Supported Failure mode, effects, and criticality analysis (FMECA)

studies.

. Set up stability program, analyzed and trend stability data and through

life testing data.

. Trained junior scientific staff to ensured adherence to company policies

and quality requirements.

. Developed analytical test methods, method validations, and aerosol

characterization studies for product formulations and novel delivery

systems, including dry powder inhalers.

. Planned and executed aerosol research and/or product development

activities.

. Interfaced with various departments, customers and partners to align

project goals and meet company milestones.

. Identified potential technical problems with aerosol characterization

testing and contributed to their resolution.

Scientist II

2005 - 2006

MAP Pharmaceuticals Inc.

Mountain View, CA

. Performed aerosol drug delivery formulation especially pressurized

metered dose inhalers (pMDIs).

. Performed method development, method validation, and analytical chemistry

characterization of formulations and novel delivery systems, including

pMDIs that met FDA and ICH guidelines.

. Trained junior scientist in utilization and maintenance of analytical

instruments

. Researched and developed assays and impurity profile methods as well as

developed novel aerosol methodologies for drug characterization

. Presented to Management evaluated analytical results using statistical

mathematical techniques on a weekly basis.

. Implemented and executed cGMP procedures in support of regulatory

submissions using in vitro methods.

. Supported technology transfers and manufacturing functions between

contract labs.

. Generated technical reports from all laboratory testing performed and

collected supporting data recorded.

Scientific Specialist

2002 - 2005

Quintiles Inc.

Kansas City, MO

. Conducted laboratory research under cGMP compliance directives in the

design, development, experimentation, evaluation, analytical testing, and

other data gathering requirements of pharmaceutical drug substances and

drug products.

. Performed analytical testing to support regulatory requirements in the

development, release or stability testing of drug substances and drug

products.

. Conducted analytical (physical and chemical) testing for medical device

using the drug substance or product with the drug delivery system under

development, release or stability testing.

. Provided assistance in the design of analytical method development and

validation for drug substances and drug products for development,

clinical release, and stability testing projects under GMP conditions.

. Performed testing using High Performance Liquid Chromatography (HPLC)

(Assay, Related Substances, and Impurities), UV Spectroscopy, microscopy,

specialized aerosol analytical techniques (i.e., Andersen Cascade

Impactor or Next Generation Impactor) for particle sizing

characterization, Dose Content Uniformity, Karl Fischer Moisture

Determination, Aerosizer particle sizing, other release and stability

aerosol tests

. Prepared data records for generation of technical reports

. Participated on analytical technical project teams and interact directly

with clients on technical issues

. Assisted with the development of laboratory standard operating procedures

for instrumentation and data recording for regulatory compliance or for

best-practice internal laboratory policy.

. Assisted with the validation and qualification of all laboratory systems

and instrumentation.

Pharmacy Technician

1999 - 2002

Walgreens Pharmacy

Fremont, CA and Richmond, VA

. Entered prescriptions into the database.

. Labeled and filled prescriptions.

. Assisted and answered patients' inquiries.

. Documented and communicated with physicians and

nurses for prescription refills.

. Maintained and managed inventory control.

Education

. Master of Science in Pharmaceutical Sciences

08/00 - 11/02

Virginia Commonwealth University, Richmond, VA

Thesis Title: Importance of Metering Valve - Formulation Interactions

on Electrical Properties in Hydrofluoroalkane Based

Pressurized Metered Dose Inhalers

. Pharmacist License

03/08

The Pharmacy Council, Thailand

. Bachelor of Science in Pharmacy

05/93 - 03/98

Chulalongkorn University, Thailand

Professional Organization

. International Society for Pharmaceutical Engineering

01/09 - 12/10

. American Association of Pharmaceutical Scientists

04/02 - 12/08

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