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Project Manager Management

Location:
New York, New York, United States
Posted:
April 21, 2017
Email:
aczw4r@r.postjobfree.com

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KENNETH WONG

**-** *** **. ******* Gardens, NY **364

TEL: (917) ***-****, E-mail: aczw4r@r.postjobfree.com

OBJECTIVE

As a well-trained and experienced GMP analytical chemist and project manager, to secure a senior management position in a pharmaceutical area that utilizes my education and skills.

SUMMARY

Over 15 years in Analytical Chemistry and 6 years in Project Management in Pharmaceutical industry, including:

Experience with laboratory management (QC, Stability, Method Transfer, Development and Validation)

Experience with extractables and leachables (E/L) studies, methods development, validation and technical transfers

Experience with promoting new products lines, such as filters, Single-Use System (SUS) and Medical Devices

Effectively prioritizes and executes tasks in a high-pressure environment execute all assigned projects from Initiation to Execution, including cross-functional and cross-divisional projects with high visibility

Strong communication skills and able to demonstrate an ability to adapt to rapidly changing project needs

EMPLOYMENT

Ropack Pharma Solutions, Commack, NY 9/2016 – 11/2016

Director, Chemical Development

-The facility was terminated due to financial crisis from the headquarter, Canada.

SGS Life Science, Fairfield, NJ 9/2013 – 9/2016

Technical Director

-Develop, manage, and communicate project budgets, timelines, and resource needs

-Negotiate with vendors and develop Statements of Work (SOW) or task orders and aid in the management of vendor resources and external consultants

-Assist in development and implementation of global policies and procedures for the marketing process and training programs

-Anticipates and resolves project-related problems; develop contingency plans to mitigate unresolved problem

-Provide technical expertise to different divisions. (Pkg Dev, QA, Manufacturing and R&D)

-Analyze need for new test equipment and develop programs to acquire same, as appropriate.

-Lead the team in all prospects of E/L studies under GMP conditions

-Manage, Track, and Report on all cross-functional science projects. (Material/Chemical Characterization, ICH Stability Services – Real Time, Accelerated, Forced Degradation, Stress Stability, R&D Stability Testing, In-Use Studies and Photostability

-Finished Product Release

-Monitor progress against plans, decision points and project milestones using project management tools to optimize performance

-Identify required improvements related to business processes, systems, organizational development, and customer satisfaction

-Communicate with customers for E/L validation studies, which include medical devices, pre-filled syringes, containers, and model solvent selections

-Provide technical support for customers and assistance with troubleshooting

-Manage the E/L chemistry teams (4 Ph.D. and 2 M.S. experienced chemists)

-Interpretation of LC/MS and GC/MS data and develop methods to ultimate separation of extractable and leachable unknown compounds

-Acquire up to date knowledge of current regulatory trends, issues and guidelines relating to the products being supported

-Have extensive interaction with outside customers including technical presentations at customer sites, evaluate process changes and review existing validations for FDA compliance

Pall Corporation, Port Washington, NY 1/2012 – 9/2013

Senior Project Manager

-Maintain up to date knowledge of current regulatory trends, issues and guidelines relating to the products being supported

-Leads and facilitates meetings including recording minutes, decisions and action items

-Provide updates on the project to the internal team and the client as well as lead project meetings, client conferences and on-site visits. If necessary be involved in corrective actions and manage the client's expectations.

-Develop and implement operations quality system consisting of policies, standards, documentation and training methods

-Support marketing team for promoting new products lines, filters and Single-Use Systems

-Review validation documentation (e.g. Protocols, Reports, and Laboratory Investigation Reports) necessary to demonstrate customer filtration system or sterilization process has been validated

-Execute and oversee validation projects with complex scope, including development of protocols and reports for new areas of Validation Services

-Interpretation of LC/MS and GC/MS data and develop methods to ultimate separation of extractable and leachable unknown compounds

-To supervise and train chemists to plan and conduct in GMP environments

-Manage the Validation Services group responsible for extractable and leachables Filters and Single-Use System (SUS) validation studies

Merck, Rahway, NJ 9/2007 – 1/2012

Senior Research Scientist

-Conduct analytical methods development and validation for API's and intermediates in order to support process chemists for improving yields, enhancing purity, identifying Potential Genotoxic Impurities by LC-MS and GC-MS

-To supervise chemists to plan, design, conduct and report complex laboratory work in support of developing new processes, technology transfers, and improving existing processes under GMP environments

-Collection of experimental data, data interpretation and report generation. Responsible to keep detailed records of all work undertaken, to present results and conclusions to colleagues

-Stability testing under ICH guidelines for supporting clinical trials, regulatory submissions (IND, NDA, and aNDA applications) and post approval studies

-Responsible to carry out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Will comply with all company and site policies and procedures

Forest Laboratories, Commack, NY 5/2001 – 8/2007

Scientist III

-Method development and validation for intermediates and APIs

-Responsibilities include maintaining laboratory documentation and equipment under strict compliance with safety, GLP, GMP, federal state and local regulations.

-Perform analytical and qualitative analysis of raw materials, excipients and finished products to support Pre-formulation, Formulation and Stability groups.

-Perform the release tests which are standardized by USP, EP and JP.

LABORATORY SKILLS

–UPLC (Waters Acquity), UHPLC (Agilent 1200 series Rapid Resolution LC)

–LC/MS (Thermo TSQ Vantage, Micromass ZQ electrospray with single Quadrople, SCIEX API3000, and TSQ Ultra, Acquity SQD)

–GC/MS (Hewlett Packard 5890, Agilent 6890N with Combi-pal; GCT Premier TOF)

–ICP-MS Agilent 7700 series in conjunction with 7890A GC

–Differential Scanning Calorimeter, ThermoGravimetric Analyzer

–Karl Fischer Titrator (Mettler Toledo DL38, Metrohm 831 KF Coulometer)

–Particle size (helos, Melvin)

EDUCATION

Queens College, City University of New York

Ph. D program

Master of Sciences - December 1996

Major: Analytical Chemistry Grade Point Average: 3.80

Queens College, City University of New York

Bachelor of Arts - June 1992, graduated cum laude

Major: Chemistry Minor: Secondary Education Grade Point Average: 3.60

–Departmental Honors in Chemistry; Dean's List, Queens College (1990-1992)

COMPUTER APPLICATION AND LANGUAGES

–Microsoft Project, PowerPoint, Excel (Advanced application) and VBA programming

–Empower, Chemstation, and MassLynx

–SAP, Quality eDoc, LabWare, TrackWise

–Lean Manufacturing Application

–English, Chinese and German (reading)

References furnished upon request



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