ALKESH M.

AMIN
15 Catelli Road
Princeton, NJ 08540
(609) 688-0605 alamin@yahoo.com

PROFESSIONAL PROFILE

Senior Manager, Quality Assurance at Kyowa Pharmaceutical, responsible for the Pre-Approval Inspection program from
inception to completion. Prepared API and finished product sites for FDA PAI inspections. Developing, revising and
implementing of quality systems impacting FDA regulated facilities worldwide. Developed systems for the quality
oversight of clinical and commercial products manufactured at internal and contract manufacturing sites worldwide.

Manager, Global Quality Operations at Schering Plough, facilitating the development, revision and implementation of
quality standards and related guidance documents impacting FDA regulated facilities worldwide. Negotiating quality
systems requirements and implementation strategies with senior management. Participating as a consent decree monitor
backup for a commercial and clinical site, encompassing the review of quality systems throughout the consent decree.

EXPERIENCE

KYOWA PHARMACEUTICAL, INC., Princeton, NJ 07/05 – Present

Senior Manager, GMP Quality Assurance

Responsible for the quality oversight of clinical and commercial products through the auditing of facilities and review of
documents to ensure adherence to FDA and KPI quality standards. Headed the PAI Program and declared both internal
and contract sites ready for Pre-Approval Inspection prior to filing of the NDA. Performing audits to assess accuracy
and quality of scientific data prepared for submission to the FDA and other global regulatory authorities in
support of INDs and NDAs. Oversee the IT Quality Assurance function. Developed systems for the quality
oversight of APIs and finished products manufactured at internal and contract facilities, including change
control, batch record review, product release, stability, annual product review, auditing and validation (process,
product, computer systems, etc.).

SCHERING-PLOUGH CORP, Kenilworth, NJ 04/02 – 07/05

Manager, Global Quality Systems

Developed standards, guidance documents and procedures that provided direction for the entire organization. Facilitated
the resolution of standard requirements and implementation issues through effective negotiations with the Global
Technical Services groups and site quality leaders. Established and maintained communication forums to allow for the
sharing of knowledge on standard requirements and implementation activities at all sites. Updated standard requirements
that provided for cost avoidance while still meeting regulatory expectations, resulting in a savings of $1.5 million.
Performed compliance risk assessments through pooled auditing which is resulting in annual savings of $500,000.

PURDUE BIOPHARMA LP, Princeton, NJ

Assistant Director, Quality Assurance 2001 – 01/02
Senior Manager, Quality Assurance 1999 – 2001

Established the quality organization for the parenteral monoclonal antibody manufacturing facility. Developed excellent
working relationships with all functional areas, resulting in a compliance posture that led to successful FDA and HPB
inspections. Developed the Right First Time program for tracking performance of all functions through the establishment
of metrics and subsequent incorporation into organizational, departmental and individual goals. Developed a program for
the sharing of compliance information to enhance the regulatory compliance status of all sites. Generated savings of $1.2
million in the first year of implementing the Right First Time program. Initiated a cost avoidance program that
eliminated redundancies in the vendor/supplier auditing functions, resulting in a savings of $1 million.
ALKESH M. AMIN Page 2

HOECHST ROUSSEL VET, Warren, NJ 1999

Supervisor, Contract Manufacturing

Established excellent relationships with contract manufacturing sites and contract laboratories that led to completion of
manufacturing and testing activities on time and in compliance with cGMPs. Operational activities included
troubleshooting and investigating manufacturing and testing issues, executing validation protocols, writing validation
protocols and reports, developing master batch records, reviewing executed batch records and performing annual product
reviews.

JOHNSON & JOHNSON, NORAMCO, INC., Wilmington, DE 1997 – 1998

Manager, Quality Assurance

Evaluated and reorganized the QA group into an efficient organization that provided timely review cycles for all services
provided. Achieved a 30% reduction in turnaround time, resulting in a savings of $200,000, while maintaining a high
level of efficiency and compliance. Experienced successful FDA Pre-Approval Inspections.

THE LIPOSOME COMPANY, INC., Princeton, NJ

Manager, Quality Assurance 1996 – 1997
Supervisor, GMP Compliance and Product Release 1994 – 1995
Compliance Associate 1993 – 1994

Established and maintained systems for the Quality Assurance oversight activities for commercial, clinical, preclinical
activities at the Princeton manufacturing facility. Instituted and maintained cGMP Training programs for all functional
areas. Established procedures and systems for Trend Analysis and Annual Review of Drug Product Quality Control
Profile. Created procedures and documentation systems for Failure Investigation Reports, Drug Product Complaints and
Recalls. Assured positive compliance posture through routine audits of the various functional areas and
vendors/suppliers. Participated in successful FDA and MCA audits, leading to approval of first commercial product.
Managed a 30% reduction in staff while maintaining a higher than expected level of output.

BIOCRAFT LABS, INC., Waldwick, NJ

Quality Assurance Supervisor 1992 – 1993
Quality Assurance Auditor 1991 – 1992
Microbiologist 1989 – 1991

Developed the QA organization through the hiring and training of all new Q.A. Employees. Developed all Q.A. SOPs and
systems for an API facility. Established and maintained the documentation, auditing, failure investigation, training and
annual product review systems.

EDUCATION

Masters in Business Administration. Rutgers University, 1997.

Master of Science, Microbiology. Seton Hall University, 1992.
Bachelor of Science, Biological Sciences. Cook College, Rutgers University, 1989.

PROFESSIONAL DATA

ASQ Certified Quality Auditor

ASQ Certified Quality Manager
NJPQCA Certified in Quality Assurance