NICHOLAS NEEQUAYE, PH.D.
38145 Augusta Drive
 Murrieta, CA 92563
Home: 951.970.7822 Alternate: 951.304.2297
Fax: 951.304.2297 
SUMMARY

Quality, scientific and compliance minded Analytical Laboratory Management
professional with proven FDA track record. Extensive experience in Analytical
Research and Development, Quality Assurance, Quality Control and Quality
Operations. Work history includes Pharmaceutical (solid dosage, injectables and
nasal/inhalation) and Medical Device industries. 
 *  Highly effective in providing overall leadership, technical direction and
administration to the laboratory staff. 
 *  Key strengths in management, mentoring and root cause analysis and
resolution of problems impacting product quality. 
 *  Solid background in current FDA analytical regulatory requirements for ANDA
submissions.

MAJOR ACCOMPLISHMENTS

 *  Set up state-of-art cGMP compliant analytical laboratories, managed
activities of formulation development and analytical development groups, and
promoted unified goals for effective collaboration, teamwork and mutual respect.
 *  Established and met group goals and objectives in line with Company
priorities. Built self-directed work teams which provided timely response to
customers needs. Identified key chemists and provided coaching and direction
effectively building centers of technical excellence within the groups.
 *  Successful interaction across multi-department and multi-discipline
divisions.
 *  Initiated over 200 projects, over 100 ANDAs filed and approved with a
history of no 483s. Noteworthy commercialized approvals include Bupropion XL,
Galantamine ER, Glipizide ER, Buspirone, Lisinopril, Nefazodone,
Oxycodone-Ibuprofen and Desogestrel-ethinyl estradiol, etc.
 *  Obtained approval for Product with no CMC-related questions using QbR based
format.
 *  Made 2 technical presentations for project strategy/approval before FDA
panel comprised of top level personnel.
 *  Honored with Technical Operations Achievement award for major contributions
to project with substantial cost saving to company.

PROFESSIONAL EXPERIENCE

WATSON PHARMACEUTICALS INC, Corona, CA 2005  *  2009
Director, Analytical Research and Development
Directed 4 groups of 40 chemists; provided analytical chemistry testing support
for the development of generic drugs. Analytical staff included Ph.Ds, MS and BS
chemists. Projects included oral contraceptives, solid-dosage forms (immediate
and extended release) and Inhalation and Nasal products. Provided resource
management; ensure timely output of data. Group activities include project
initiation, API vendor selection, method development and validation, formulation
development support, documentation of reports including current FDA Questions
based Review (QBR) and Quality Overall Summary (QOS) for ANDA submission. Managed
method transfers from R from API vendor evaluation to final specifications of the
commercialized drug substance and product. Established and managed budgets of
$5-7 million annually. Analytical tools included
 *  HPLC, UPLC, LC-MS, UV, Fluorescence, Refractive index, GC and GC-MS
 *  Fully automated dissolution systems (USP apparatus 1, 2, 3 & 4), 
 *  Physical and Reverse Engineering tools include Particle size by Malvern
Mastersizer, hot-stage microscopy, Differential scanning calorimeter (DSC), FTIR,
Thermo graphic analyzer (TGA), 
 *  Chemical imaging Near Infra-red spectroscopy (CI-NIR), X-ray and Raman
spectroscopy. 
 *  Wet chemistry tests include methods in USP General Chapters. 

NICHOLAS NEEQUAYE, PH.D. PAGE TWO

WATSON PHARMACEUTICALS INC, Corona, CA 2003  *  2005
Director, Product Development
Oversaw the operations of formulation scientists and chemists; provided
technical leadership in the initiation, development and filing of generic
pharmaceutical products. Built up human resource pool; hiring key employees after
relocation of group from Cincinnati to Corona. Established an effective working
group based on teamwork within and between cross-functional departments.

WATSON PHARMACEUTICALS INC, Cincinnati, OH 1998  *  2003
Director, Product Development 2002  *  2003
Supervised the operations of formulation scientists and chemists; provided
leadership in the development and filing of generic pharmaceutical products. 
Associate Director, Analytical Research and Development 2000  *  2002
Coordinated workflow of about 25 chemists; provided scientific strategies for
method development and modifications and critical assessment of product quality.
Provided analytical chemistry support; development of generic pharmaceutical
drugs. 
Manager, Analytical Research and Development 1998  *  2000
Managed all analytical testing activities of the analytical group. Performed
method development and validations.
 *  Obtained FDA approvals for critical products for commercialization including
First to file and PIV.
 
CHELSEA LABS, Cincinnati, OH (Acquired by Watson Laboratories in 1998) 1994  * 
1998
Manager, Analytical Research and Development
Oversaw all analytical testing activities of the analytical group; performed
method development and validations.
 *  Set up state-of-art cGMP compliant analytical laboratory after relocation
from New York.
 *  Obtained FDA approvals for critical products for commercialization including
First to file and PIV.

BOEHRINGER-MANNHEIM (now Roche Diagnostics), Indianapolis, IN 1991  *  1994
Quality Services Manager
Troubleshot product and raw material problems. Actively enforced ISO 9000
guidelines.
 *  Proactively developed processes to reduce downtime and shorten cycle time.
 *  Developed and validated more efficient analytical methods (HPLC, UV, GC).
 *  Analyzed product lot to lot differences and obtained a generic model for
calibration which saved the company $750K in testing costs.

OTHER PROFESSIONAL EXPERIENCE
QUAD PHARMACEUTICALS, Indianapolis, IN Laboratory Supervisor, Analytical R&D
DANBURY PHARMACAL INC (now Watson Labs), Danbury, CT Senior Analytical Chemist,
Quality Control

EDUCATION

PhD, Chemistry, University of Southampton, Southampton, England
BSc with honors, Biochemistry and Chemistry, University of Ghana, Legon, Ghana

PROFESSIONAL AFFILIATIONS
American Association of Pharmaceutical Scientists (AAPS); American Chemical
Society (ACS),