Project Manager

ALEXANDER THOMAS, PMP

**** ********** *****

Branchburg, NJ 08853

908-***-**** (H) ? 908-***-**** (C)

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

SUMMARY

Over 15 years of extensive experience as an analytical chemist, Project

Lead, Supervisor and Manager in QC laboratories in pharmaceutical,

biotechnology, chemicals and cosmetic companies.

. Excellent supervisory and Project management experience for the past five

years.

. Excellent knowledge in Quality Systems, and FDA's six system approach for

quality audit.

. Excellent knowledge of GMP, GLP, GCP, NDA/IND, SDLC, Quality Audit, Drug

Development, SPC, Computer System Validation and Complete Drug life

Cycle.

. Over 10 years of Experience with LIMS and Database Management System

(SAP).

. Over 5 years of project management experience and PMP certified. Familiar

with MS Project 2010

. Investigated testing abnormalities and implemented corrective and

preventive actions.

. Determined root causes of non-conformances and recommended corrective

actions.

. Conducted periodic lab audits by reviewing the documentation, device

history records, log books, etc., to ensure that the QC Lab met the

requirements of cGMP and 21CFR Part 11 compliance.

. Coordinated testing responsibilities to ensure QC releases raw materials

and bulks according to the needs of Manufacturing to maintain continuous

process flow.

. Prepared change control request (CCR) packages and submitted to the

change control board for updating or for changing analytical methods,

directions for testing and SOP's

. Led the cleaning validation recovery study using Total Organic Carbon

analyzer (TOC).

. Extensive experiences and in-depth knowledge of analytical

instrumentation and modern methodologies such as GC, HPLC, UV-VIS, FT-IR,

TOC & Coagulation analyzer, Particle size analyzer, Titrators, and

Dissolution etc.

. Developed and validated Analytical Methods.

. Excellent communication, interpersonal, documentation, and computer

skills.

EDUCATION AND PROFESSIONAL TRAININGS & CERTIFICATIONS

M.S., Quality Assurance and Regulatory Affairs, Temple University,

Philadelphia, PA, 2005

M.S., Organic Chemistry specialized in Drug Chemistry, Bhopal University,

India, 1993

PMP Certified, July 2010

Laboratory Analyst Training Certification Program by Johnson and Johnson,

2001

Rutgers/ Roche Management Training, 2006

Diploma in Industrial Analytical Chemistry, Ram Narain Ruia College, Bombay

University, 1990

PROFESSIONAL EXPERIENCE

Johnson & Johnson (Consultant) - Fort Washington, PA

Feb 2012 - Present

QA Compliance Specialist for Consent Decree Project

. Preparation of Audit Agenda. Facilitation of the audits.

. Responsible for the GDP /GMP compliance of all documents pertaining to

the Consent Decree Project. Follow up of audit findings, responses,

commitments, and tracking the closure of the audit findings and

commitments with verification of evidence.

. Keeping the governance bodies informed of audit outcomes and completion

of commitments

Sanofi Pasteur (Consultant) - Swiftwater, PA

Manager, Project Lead (TOC Method Validation)

Feb 2011- Feb 2012

. Responsible for the daily supervision of a group of three Method

validation Scientists in accordance with the established lab policies,

analytical methodologies and safety procedure.

. Managed the Project using project management tools, methodologies and

principles.

. Led the validation execution work, prepared the validation summary report

and get it approved by QPQV (Quality Project Quality Validation).

. Successfully completed and closed the project.

Roche Molecular Systems, Branchburg, NJ

Sep 2001 - June 2009

QC Manager, Principal Scientist (2006 - 2009)

. Responsible for the daily supervision of a raw material's group of four

QC Scientists in accordance with established lab policies, analytical

methodologies and safety procedures.

. Led several QC projects that involve relocation, method validation, Lab

qualifications, process validation and SOP harmonization. Managed these

Projects using project management tools, methodologies and principles.

. Set annual goals and their target dates for the staff in accordance with

corporate goals, and evaluated their performance quarterly.

. Used scientific expertise to provide assistance to associates for

troubleshooting, laboratory investigations and problem resolution.

Implemented process improvements with management.

. Assured adherence of acceptable cGMP practices by associates during

execution of all work tasks.

. Attended new product launch meetings and met deadlines for writing the

DFT's and corresponding LIMS programming, etc.

Senior Scientist (2001 - 2006)

. Performed assay validation and development, as well as routine QC work

which included the analyses of raw materials utilizing HPLC, GC, TOC, and

UV-VIS Spectrophotometer, etc.

Ortho McNeil Pharmaceutical Company (Johnson & Johnson), Raritan, NJ

Aug 2000 - Sep 2001

Scientist (Stability)

. Performed analysis of pharmaceutical finished products (solids and semi

solids) stability samples at various times utilizing HPLC, GC, etc.

Merck &Co, Rahway, NJ (Consultant)

Jul 1999 - Aug 2000

Quality Control Chemist -In-process Lab

. Analyzed raw materials, active pharmaceutical ingredients (API) and

intermediates pertaining to the production of leading bulk drugs

utilizing HPLC, GC, TLC, KF, etc.

V.I. Technologies Inc., Melville, N

Jun 1995 - Jul 1999

Senior Analyst / LIMS Administrator

. Performed assay validation and development, as well as routine QC work

which included the analyses of raw materials, stability samples, in-

process samples, and final products utilizing HPLC, GC, TOC, Automated

Coagulation Laboratory 300, and Flame Photometry.

. Developed and validated many analytical methods using wet chemical and

instrumental techniques.

. Wrote SOP's, assay validation protocols and final reports.

. Participated in several projects leading to FDA approval of VIPLASMA

(Viral Inactivated Plasma).

. Participated in the Installation and administration of LIMS quality

management software (STARLIMS USA).

Invamed Inc., Dayton, NJ

Aug 1994 - Jun 1995

Q.C. Chemist

. Performed assays utilizing GC, FT-IR, UV-VIS, TGA, and DTA on raw

materials, finished products, stability samples, and in process samples

according to U.S. pharmacopoeia and internal protocol. Participated in

projects leading to FDA approval of O.T.C products.

The Calcutta Chemical Co and Kaveri Chemicals, India Jun 1985 - Dec

1990

Q.C. Chemist

. Performed the analyses of raw and finished materials pertaining to the

production of pharmaceuticals, cosmetics, disinfectants, and detergents

according to the Indian Pharmacopoeia, British Pharmacopeia, and National

Formulary.

Instrumentation

GC, HPLC, TOC, FT-IR, UV-VIS, TGA, Particle Size Analyzer

TECHNICAL SKILLS

Microsoft Project 2010, Familiar with Client-Server Environment,

Documentation systems such as Netdocs, documentum, etc, Beckmann Coulter

2002 (Version 9.1B), LIMS and SAP

Seagate Crystal Reports 7.0

MS Excel, MS Word

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