CHEMIST / PROJECT MANAGER

PROFILE OVERVIEW

Innovative and highly analytical professional with 18 years of well-rounded pharmaceutical industry experience and strong leadership qualifications. Accustomed to realigning project plans and in streamlining procedures to guarantee efficient and on time project completion. Systematic in improving procedures to optimize throughput, as well as in leading teams toward compliance and efficiency. Proficient with USP, EP, and Compendia, with expertise in HPLC and TLC instrumentation. Core competencies include:

PROJECT PLANNING AND COORDINATION |RESEARCH AND LABORATORY FUNCTIONS |TIME / RESOURCE MANAGEMENT DOCUMENTATION AND REPORTING |CROSS-FUNCTIONAL COLLABORATION |INTERPERSONAL RELATIONS |PROBLEM ANALYSIS AND RESOLUTION |PRIORITIZATION OF WORK |QUALITY ASSURANCE

PROFESSIONAL EXPERIENCE

Pfizer Global Research and Development-Groton, CT

PROJECT MANAGER Oct 2007-Present

- Define and develop blinding options for comparative agents, such as deinking, over-encapsulation, over-printing, and overwaxing for immediate release tablets, parenterals, nasal sprays, and inhalation devices

- Achieve project timelines and budgetary requirements by facilitating meetings that drive projects forward, coordinating issues and updates, and ensuring efficient project execution

- Lead and optimize the development and validation of analytical methods needed for blinded comparative agent projects, such as water and dissolution

- Develop and verify effectiveness of analytical test methods and LIMS specifications

- Monitor compliance and efficiency of CROs through annual technical and quality audits

- Manage and ensure completeness of documents for regulatory filings

- Establish standards and policies for storage conditions and restrictions of product compounds

- Assign expiry periods, assess temperature excursions, and investigate expiry extensions of drug compounds

PROJECT ANALYST Apr 2005-Oct 2007

- Directed and streamlined exploratory projects through Phase I and II of development

- Facilitated HPLC studies using Waters HPLC systems and Empower software in a cGMP lab

- Leveraged skills and knowledge in method development, method validation, release testing, stability testing, dosing instruction validation, and pilot samples in support of HPLC studies

TECHNICAL WRITER Dec 2003-Mar 2005

- Accurately compiled data and prepared documents for IND submissions to the FDA

- Served as information resource for the FDA

- Managed and maintained organization of data using Documentum and Predict software

RELEASE COORDINATOR Feb-Nov 2003

- Examined GMP (Good Manufacturing Practice) documents and processed releases including: Commercial Releases, Comparative Agents, and In-Process Releases

- Determined proper testing pattern of excipients and packaging components and forwarded them for testing to CROs

- Ensured optimum quality of products for use in further manufacturing through thorough data review and preparation of test notes and C of A (certificate of analysis)

LAB SUPERVISOR Feb 1997-Apr 2004

- Oversaw and ensured performance efficiency of three direct reports in the Thin Layer Chromatography Laboratory

- Provided strategic direction in all method development and validation of TLC procedures

- Authored innovative test procedures and validation protocols upon completion

- Functioned as outsourcing coordinator responsible for providing samples to three contract labs for TLC testing and auditing labs periodically

- Verified accuracy and completeness of notebooks, methods, reports, and protocols

- Managed and realigned all efforts in project execution and delivery, including customer service and project tracking

PRIOR EXPERIENCE

Bench Chemist Pfizer Global Research and Development, Groton, CT (Apr 1996-Feb 1997)

Math Instructor Three Rivers Community College, Norwich, CT (Feb 1997-Feb 1999)

Bench Chemist Rosemont Pharmaceutical Corporation, Denver, CO (Aug 1995-Jan 1996)

Bench Chemist Wyeth-Ayerst Research, Rouses Point, NY (Aug 1992-Aug 1995)

PUBLICATIONS

- Chapter 13 entitled, "Thin Layer Chromatography." Published in Modern Instrumental Analysis (2005)

- Chapter 9 entitled, “Isolation Methods I: Thin-Layer Chromatography." Published in Handbook of Isolation and Characterization of Impurities in Pharmaceuticals (2003)

CONFERENCES AND PRESENTATIONS

Conferences

2009 Global Congress on Comparator Studies. Philadelphia, PA

2005 COSMOS 2005, Bristol, RI

2000 International Symposium on Planar Chromatography, Lillafured, Hungary

2000 Analytical Symposium, Novi, MI

1999 Eastern Analytical Symposium, Somerset, NJ

1998 ANALYTICA 98, Munich, Germany

1998 Eastern Analytical Symposium, Somerset, NJ

1997 AAPS, Boston, Mass

Presentation

2003 FACSS, Ft. Lauderdale, FL

EDUCATION

(BA) BACHELOR OF ARTS IN CHEMISTRY (1992)

Purdue University -West Lafayette, IN

PROFESSIONAL TRAINING

Lab Training | Supervisor Training | HPLC Method Development | Fundamentals of Supervision I and II

HPLC Maintenance & Troubleshooting | Managing for Improved Performance | TLC Method Development

Managing in a Research Environment | Empower DAD | Essentials of Writing Scientific Research Papers | Effective Oral Presentations | Presentation Skills I, II, and III | Advanced Oral Presentations | Technical Writing

Performance Management

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