
David Whitesell
Develop business relationship with third party contract manufacturing facilities which also perform analytical testing from product development through... | Dublin, Dublin, United States
*50 free lookup(s) per month.
No credit card required.
David Whitesell’s Emails dw****@we****.com
David Whitesell’s Phone Numbers No phone number available.
Social Media
David Whitesell’s Location Dublin, Dublin, United States
David Whitesell’s Expertise Develop business relationship with third party contract manufacturing facilities which also perform analytical testing from product development through Commercialization. Responsible for internal development groups which support GMP analytical chemistry for submission to the FDA as part of the CMC section in an ANDA. Responsible for monitoring the departmental expense budget. Lead departmental change initiatives as required for the growth and development of the organization. Directs front line supervisors for staff development and successful product development. Served as project manager for departmental change initiatives.Responsible for the technical development of analytical chemistry method Development for two development section groups. Responsible to bring new technologies into the department Malvern, XRD, SEM, GCMS, ELSD for HPLC. Focus on current regulatory requirements and assuring development groups are meeting changing standards.Built Active Pharmaceutical Igredient group for the Analytical Development Department. Improved technical capabilities by bringing in Malvern Particle Size, Scanning Electron Microscope, and Powder X-ray Defraction instrumentation. Provided leadership for method development of various analytical techniques.Supervisor for Analytical Methods Development group. The group was responsible for developing, validating, providing formulation support activities, filing stability studies, as well providing regulatory filing documentation for ANDA filings. Provide training and development opportunities for Scientist.Analytical methods development scientist with focus on HPLC methods for drug products to support the development generic pharmaceutical drug products. Developed snd validated methods for dissolution, assay, and impurities in product matrices.Blood glucose device development group. Designed experiments to evaluate the robustness of blood glucose monitors. Generated device validation data for regulatory filings.Developed generic injectable drug dosage forms. Experience in clean room technologies, lyophilization, and aseptic techniques. Developed stable formulations for ANDA submissions to FDA. Developed standard operating procedures for formulations development department.Lead cGMP development group responsible for release and stability testing in support of ANDA submissions for generic drug applications. Monitor and make departmental budget recommendations for capital and expense. Develop visual management systems to easily illustrate the status of projects for senior management.
David Whitesell’s Current Industry West-Ward Pharmaceuticals
David
Whitesell’s Prior Industry
QUAD Pharmaceuticals
|
Boehringer Mannheim
|
Roxane Laboratories
|
Boehringer Ingelheim Roxane Lanoratories
|
Boehringer Ingelheim Roxane Laboratories
|
Boehringer Ingelheim Roxane Laboratorie
|
West-Ward Pharmaceuticals
Not the David Whitesell you were looking for?
Find accurate emails & phone numbers for over 700M professionals.
Work Experience

West-Ward Pharmaceuticals
Associate Director
Tue Mar 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jun 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Boehringer Ingelheim Roxane Laboratories
Associate Director
Sun Jul 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Feb 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
Boehringer Ingelheim Roxane Laboratorie
Manager
Sun Apr 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Apr 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time)
Boehringer Ingelheim Roxane Laboratories
Manager
Mon Jan 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jul 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time)
Boehringer Ingelheim Roxane Lanoratories
Section Head
Mon Jan 01 1996 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jan 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time)
Roxane Laboratories
Scientist
Wed Jul 01 1992 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jan 01 1996 00:00:00 GMT+0000 (Coordinated Universal Time)
Boehringer Mannheim
Scientist
Tue Oct 01 1991 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jul 01 1992 00:00:00 GMT+0000 (Coordinated Universal Time)
QUAD Pharmaceuticals
Formulations Scientist
Tue Sep 01 1987 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Oct 01 1991 00:00:00 GMT+0000 (Coordinated Universal Time)