Analytical Chemist

JANE RIPA

*** ********** **. *-****: *******@*******.*** Home: 845-***-****

Valley Cottage, NY 10989

ANALYTICAL DEVELOPMENT CHEMIST

Meticulous and thorough analytical development chemist with extensive experience in the pharmaceutical and oil & gas industries. Exceptional analytical, design and problem solving skills. Comfortable working independently or as part of a team. Proven leadership skills involving managing, developing and motivating teams to achieve their objectives. Accomplished project management ability with solid administrative and organizational skills. Dedicated to maintaining high quality GMP standards.

CORE COMPETENCIES

Method Validation – Strong track record in completing analytical method validations as part of NDA submission packages.

New Laboratory Start-up – Expertise starting analytical QA/QC laboratories for testing of samples to support characterization of drug substances and drug products in late stages of development (Phase 3 and 2B).

Project Management – Directed/Authored protocol writing, sample testing and project report writing for several API supplier and process changes.

Continuous Improvement & Training – Designed and instituted training programs for new hires. Developed cross-training seminars and carried out training sessions related to FDA compliance.

PROFESSIONAL EXPERIENCE

PFIZER, INC., (formerly Wyeth Pharmaceuticals), Pearl River, NY (1989 – 2010)

Analytical Development Chemist IV (2008 – 2010)

Characterized Active Pharmaceutical Ingredients (APIs), in-process blend samples and finished drug products during late stages of drug development. Planned and executed complex analytical projects using any combination of the following instruments: UPLC and HPLC, Thermal Analysis (TGA/DSC), LC/MS, Infrared Spectrometers, KF Coulometric and Volumetric Titrators, NMR Spectrometers, GC, and UV Spectrophotometers. Documented comprehensive technical reports. Authored SOPs for laboratory instrumentation and GMP laboratory procedures.

Achievements:

• Spearheaded the creation of multi-million dollar analytical laboratory for the testing of samples to support characterization of drug substances and drug products in the late stages of development (Phase 3 and 2B).

• Subject Matter Expert (SME) for Waters UPLC and TA Instruments DSC/TGA laboratory instruments. Developed cross-training seminars and carried out training sessions.

• Collaboratively implemented a networked system of Empower 2 chromatography and results management software in the global quality analytical development laboratories that allowed a high degree of flexibility and scalability across the company.

• Insured trainees’ needs were met in learning Empower 2 by interviewing cross-section of chemists and analysts, identifing their needs, and designing training courses that increased sample throughput two-fold and decreased results processing time by a third without compromising lab performance and data integrity.

Analytical Development Chemist III (1997 – 2008)

Completed the analytical work necessary to qualify new vendors and/or processes of APIs with respect to special testing characterization and volatile impurities. Activities involved method development and validation using GMP laboratory instruments including HPLC, LC/MS, Infrared Spectrometers, NMR Spectrometers, GC, Thermal Analysis (TGA/DSC), and UV Spectrophotometers. Documented all of this data into comprehensive technical reports which were then submitted to the FDA.

Achievements:

• Completed analytical work, compiling the data and authoring eight comprehensive project reports required by the FDA explaining the change in the manufacturing process for Venlafaxine HCl (Effexor ), which was cost effective to the company and is regarded key to Wyeth’s Effexor financial future.

• Completed method validations at Wyeth’s Newbridge, Ireland site as part of Wyeth’s European Product Compliance (EPC) initiative which improved the way we did business.

• Achieved performance qualification and testing validation of thermal analysis equipment in Global Analytical Development Laboratory relating to Pearl River Consent Decree activities.

• Solved major quality assurance problems and completed laboratory investigations which had temporarily halted production of several major Wyeth products.

Reference Standards Chemist (1992 – 1997)

Completed analytical testing on primary and secondary reference standards for use by other Wyeth testing laboratories. Activities involved using the following GMP analytical instrumentation: HPLC, GC, UV Spectrophotometers, TLC, DSC/TGA and Karl Fisher titrators and general wet chemistry techniques. Characterized reference standards and generated data necessary for Certificates of Analysis. Maintained the department’s database of reference standards. Assured that departmental SOPs were being followed and all products manufactured by Wyeth-Ayerst/Lederle were in compliance with cGMP set forth by the FDA.

Achievements:

• Coordinated and maintained monthly reference standards testing schedule.

• Enhanced customer service satisfaction (5%) annually during 1994-1996 (measured by order fill and on-time mail delivery percentage) through inventory control and compliant reference standard filling practices.

• Provided individualized instruction to new hires and taught several assays’ mechanism of action, improving understanding of assay procedures for analysts performing the tests.

Scientific Assistant (1989 – 1992)

Performed analytical testing on drug actives and drug products through the various stages of manufacturing. Collected and analyzed routine samples in the Departments of Fermentation, Refining and Finishing. Presented results to team of chemical engineers. Assured that departmental SOPs were being followed and all products manufactured by Lederle were in compliance with cGMP set forth by the FDA.

Analytical instrumentation: HPLC, GC, UV Spectrophotomers, Potentiometric Titrators, KF Coulometric and Volumetric Titrators Potentiometric Titrators, Atomic Absorption.

EDUCATION

• MBA (HR Management) Iona College, Hagen School of Business, New Rochelle, NY 10801

• B A Degree (Chemistry) Empire State College, Saratoga, NY (SUNY) 12866

• AAS Degree (Chemical Technology) Rockland Community College, Suffern, NY 10901

PROFESSIONAL DEVELOPMENT

Completed continuing education and training courses in the following:

• Empower 2 Software Enterprise

• Sytem Administration and Maintenance

• Advanced Topics: Custom Reports, Aquistion and Processing, PDA

• Project Management

• GXPharma for SOPs and regulated documents (21 CFR Part 11 Compliance)

• Effective Business Writing

• Efficient Method Development

• Stability Indicating HPLC Method Development

• Investigations Training: Situation Review & Root Cause Analysis

• NMR Spectroscopy: Methods, Interpretation and Strategies for Problem Solving

• Cultural Harmony

SPECIAL AWARDS/PRESENTATIONS

• Employee of the Month Wyeth-Ayerst/Lederle

• Local Running/Track Awards 5K/10K races in Rockland County

• Ripa, Jane “Training & Development Program for Laboratory Analysts”

• Ripa, Jane “Operation of Differential Scanning Calorimeter (DSC)”

• Ripa, Jane “Operation of Thermogravimeter Analyzer (TGA)”

• Butwell, K.F. and Ripa, Jane “Primary versus Secondary Amines – Characteristics in Gas Conditioning” presented at the Gas Conditioning Conference, Norman, OK

PROFESSIONAL & COMMUNITY CONTRIBUTIONS

• Librarian Assistant (Valley Cottage Free Library)

• Tutor for Literacy Volunteers of Rockland County

LANGUAGES

• Italian with 3 years of study at Rockland Community College and a summer semester in Florence, Italy

• 5 years of Spanish

Contact this candidate