Development Manager

Title:Ronald Vogel

********@**********.***

Document

Source below

Name: Ronald Vogel

Address:

City: Pittstown

State: NJ

Zip/Postal Code: 08867

Country:

E-mail: ********@**********.***

Primary Phone:

Background

Most Recent Job Title: Senior Scientist

Most Recent Employer: Merck

Career Level: Senior (Non-Manager)

Availability or Timeframe: Immediately

Authorized to work in the US: Yes

Security Clearance:

Do you have transportation: Yes

Over 18: Yes

Education: Masters

Languages Spoken: English, German

Job Preferences

Desired Salary: Open

Willing to Relocate:

Desired Job Titles: senior secientist

analytical chemist

principal scientist

Desired Job Types: Contract, Employee

Work Status: Full Time

Desired Shifts:

Desired Travel:

Category: Engineering and Research, Manufacturing/Industrial

Company Size:

Company Type:

Industry: Biotechnology, Pharmaceuticals

View Emails To Candidate close

Email Status close

close

Forward Candidate(s) Status close

Saving close

Save To:

Note:

Resume Reserve and LeadLink data may only be used for contact directly related to

employment. Use of these free online services is subject to the Terms of Use. Resume

Reserve and LeadLink Terms of Use prohibit automated extraction of data, marketing, or

fees of any kind. Resume Reserve data is private and may only be used by authorized

individuals. Access codes for resume viewing and job lead posting are issued and owned by

LHH and will be revoked if misused.

Send questions to: *******@***.***

To review the Terms of Use, click here.

Copyright c 1997- Lee Hecht Harrison, Inc.

RONALD VOGEL

1716 Route 519

Pittstown, NJ 08867 908-***-**** 908-***-**** Cell

********@**********.***

SUMMARY

Analytical Research Chemist with extensive experience in the analytical development of

new chemical entities (NCE) and pharmaceutical drug products. Expertise in advanced HPLC

method development and GMP method validation. Skilled in designing experiments, conducting

analytical investigations, troubleshooting and resolving technical issues, and writing

technical reports. Proficient in UPLC, HPLC, LC-MS, UV, TLC, IR, Raman and GC techniques.

Adept at preparing technical sections of IND, NDA, ANDA, MAA regulatory documents and

following FDA and international guidelines. Ability to combine creativity and technical

expertise to invent novel testing techniques and reduce development cycle times.

PROFESSIONAL EXPERIENCE

MERCK/ SCHERING PLOUGH CORP

., Summit, NJ

Senior Scientist, Merck Sharp and Dohme Corp. (2009-2010)

Performed as member of early development group responsible for development, testing,

validation, and release activities of multiple projects for API and drug product used in

FIH and toxicology studies.

Contributed analytical expertise to Pharmaceutical Science Development team, helping to

identify project activities and ensure timely completion of projects.

Co-authored a best-practice document for HPLC method development, enabling scientific

staff to reduce time spent on method development activities.

Effectively developed and validated numerous analytical methods, complying with current

GMP and ICH guidelines.

Gained cross-functional concurrence to establish strategy for developing an early phase

reference standard, resulting in increased efficiencies of drug substance release and

initiation of FIH studies.

Utilized expertise to thoroughly plan and prepare drug substance stability studies for

use in regulatory submissions, ensuring compliance with ICH standards.

Coached and trained less experienced analysts in multiple analytical instrumental

techniques including UPLC, HPLC, and GC, resulting in self-sufficiency and improved group

productivity.

Senior Scientist, Schering Plough Corp. (2001-2009)

Analyzed NCEs from phase one through phase three of pharmaceutical development. Prepared

analytical method transfer protocols and oversaw method transfer activities. Supervised

and coached junior-level chemists in a GMP laboratory environment.

Promoted efficiency by developing accurate, fit-for-purpose analytical methods for drug

substances (API), drug products, and intermediates.

Leveraged writing skills to prepare clear and concise technical reports on stability,

potential impurity, degradation product, and reference standards used in regulatory

submissions.

Assumed additional responsibility for monitoring activities of CROs for outsourced

projects, conducting weekly meetings to ensure compliance with SOPs.

Developed a fast, sensitive HPLC method capable of detecting single ppm levels of a

potential genotoxic impurity in an API, reducing amount of biological testing required.

Successfully expedited formulation development using a Fiber Optic Dissolution Apparatus

to quickly determine the dissolution profiles of exploratory drug product formulations.

Combined creativity and technical expertise to develop a novel HPLC method capable of

measuring low-level impurities in lactose, subsequently published in Trends in

Chromatography Journal.

RONALD VOGEL 908-***-****) PAGE 2

Assistant Scientist 1

(1983-1986)

Progressed through a variety of increasingly responsible positions in the Pharmaceutical

and Analytical Research & Development organization. Wrote numerous analytical method and

method validation reports.

Expedited development and validation of analytical methods for APIs and drug products.

Established and validated methods for APIs in toxicological and biological matrices.

Developed a novel HPTLC method to separate steroid epimers and related compounds.

Provided analytical support to chemical development organization, contributing to

enhanced drug substance quality.

Set up API stability studies, conducted stability testing, reviewed data, and wrote

corresponding stability reports with minimal supervision.

EDUCATION

MS

in Chemistry, Fairleigh Dickinson University, Teaneck, N.J.

BS

in Chemistry, Montclair State College, Upper Montclair, N.J.

PUBLICATIONS

POSTER SESSIONS

Analysis of SCH 900518 API for Low Level Hydroxy-Dibromo Impurities ; SPRI PharmSci

Symposium, January 2008

Determination of Low Level Impurities in Lactose ; SPRI PharmSci Symposium, November

2006

HPTLC Method Development of Steroid Epimers and Related Compounds using AMD Gradient

Elution ; AAPS Convention, Washington, D.C., Fall 1991

TECHNICAL SKILLS

MS Word, Excel, PowerPoint

Turbochrom, Millennium 32, LabWare LIMS, HP Chemstation, Empower 2

OTHER

Conversant in German

Contact this candidate