Project Manager
Resume:
NARENDER MAHAJAN
Keller, TX. 76244
Home: 817-***-**** Cell: 630-***-****
mjbikx@r.postjobfree.com
OBJECTIVE
Seeking a position within the medical device/pharmaceutical industry with a future to which I can be a contributing team member.
CAREER SUMMARY
Management experience in managing quality control laboratory with a staff of three supervisors and eighteen chemists.
Extensive pharmaceutical industry experience in the area of analytical method development and validation.
Pharmaceutical consulting experience in the area of compliance and analytical method validation remediation projects.
Strong technical skills with laboratory instruments HPLC, GC, UV/VIS, FTIR, AA, Karl-Fischer and TLC.
Extensive experience in writing SOPs, protocols and technical reports.
Extensive experience in reviewing and approving investigations and implementing CAPA.
Strong knowledge of FDA regulations and compliance.
Excellent leadership skills in the area of communication, collaboration, and decision- making.
Strong work ethics and goal oriented.
PROFESSIONAL EXPERIENCE
Compliance Partners, LLC
Barrington, IL 60010
Consultant
June 2010 – November 2010
Client: Biotest Pharmaceuticals
Wrote protocols on method validation of surface swab recovery of plasma residuals from stainless steel, polyvinylidene fluoride (PVDF) and borosilicate glass coupons by TOC analysis.
Determined and calculated the MACO values of plasma and detergents for cleaning validation.
Trained technicians on how to swab the coupons for surface swab recovery studies.
Responsible for writing method validation reports for surface swab recovery studies.
Sovereign Pharmaceuticals, LTD, Fort Worth, Texas 76118
Manager, Quality Control
December 2008 – March 2010
Managed and supervised daily activities of raw material releases, finished product releases, process validation testing and stability testing.
Prioritized laboratory testing to consistently meet or exceed departmental and company goals.
Reduced backlog and analytical cycle times of stability and final product while promoting a culture of right first time.
Reviewed and approved investigations and implemented CAPA.
Maintained cGMP compliance in the laboratory.
Reviewed and approved the Annual Product Reviews, Process Validation Protocols and Reports.
Wrote new and modified existing SOPs.
Contributed to regulatory submission the quality control data.
Performed regular laboratory audits/inspections to identify potential problems and ensure compliance.
Performed annual evaluation of three supervisors and eighteen chemists.
Brent Tech Inc. Chapel Hill, NC. 27516
Consultant
January 2007 – December 2007
Client: Watson Pharmaceuticals, Inc.
Completed analytical method validation remediation project in quality control.
Wrote and reviewed protocols and final reports.
Performed gap analysis of raw material testing.
Vintage Pharmaceuticals, LLC Huntsville, AL. 35811
Manager, Quality Control
April 2005 – January 2007
Managed daily activities of raw material releases, finished product releases, process validation testing and stability testing.
Maintained cGMP and cGLP compliance in the laboratory.
Reviewed and approved the Annual Product Reviews, Process Validation Protocols and Reports.
Wrote new and modified existing SOPs.
Contributed to regulatory submission the quality control data.
Performed regular laboratory audits to identify potential problems and ensure compliance.
Reviewed and approved analytical method validation protocols and reports.
Reviewed and approved investigations and implemented CAPA.
Performed laboratory methods harmonization between two quality control laboratories.
Performed annual evaluation of three supervisors and sixteen chemists.
Chicago Labs, Inc. Chicago, IL. 60612
Manager
September 2004 – April 2005
Bought laboratory instruments to set up new analytical laboratory and maintained the laboratory under compliance. Trained graduate students on laboratory instruments operation.
Pharmaceutical Systems Inc. Mundelein, IL. 60060
Consultant
April 2003 – May 2004
Client: Alpharma pharmaceutical company and Watson Pharmaceuticals, Inc.
Performed technical review of laboratory protocols and final reports.
Completed analytical method validation remediation project in quality control.
Audited quality control laboratory data and laboratory investigation reports.
Wrote protocols and modified SOPs.
Protocol Link, Inc. Vernon Hills, IL 60061
November 2002 – March 2003
Client: Alpharma pharmaceutical company
Wrote protocols and final reports for the qualification (IQ/OQ/PQ) of laboratory instruments (HPLC and GC).
Performed annual product review assessment.
American Pharmaceutical Partners Inc., Melrose Park, IL 60160
Senior Scientist
March 1984 – January 2002
Developed several new formulations of liquid and lyophilized parenteral drug products under cGMP compliance.
Identified the source of particulates in liquid products using FTIR microscopy techniques.
Developed and validated analytical methods for raw material and finished products.
Wrote SOPs, development protocols and final reports of analytical method validation.
Performed raw material and finished products analysis using various analytical techniques such as HPLC, GC, UV, pH, particle size and Karl-Fischer.
Prepared raw material, finished product specifications and final stability summaries for ANDA submission.
Wrote technical reports on special projects.
Reviewed laboratory data under cGMP compliance.
Generated technical data to present in marketing brochures on special market support projects.
Received a team award for working on antineoplastic drugs.
Supervised and trained laboratory personnel.
University of Illinois, Clinical Pharmacokinetics Laboratory, Chicago, IL.
Chemist
April 1981 - February1984
Developed and modified methods for anticonvulsant and antiarrythmic drugs in serum and urine samples using chromatographic techniques.
Northwestern University, Evanston, IL.
Chemist
February 1979 – March 1981
Performed routine analysis to measure drug levels in serum and urine samples and other radioimmunoassay analysis.
EDUCATION
M.S. in Biochemistry, Roosevelt University, Chicago, Illinois
B.S. in Biology and Chemistry, Punjab University, Chandigarh, India
AFFILIATIONS
American Association of Pharmaceutical Scientists.
PERSONAL
U.S. Citizen
PUBLICATIONS
N. Mahajan, Donald Jung, et al, An Improved Micro-Scale Liquid Chromatographic Assay for Piperacillin in Plasma and Urine. Clinical Chemistry, Vol. 30, No. 1, 1984.
N. Mahajan, S. Pai, A. Alam and J. Kapoor, Vancomycin Quantitation by High Performance Liquid Chromatography in Serum. Pharmaceutical Research, Vol. 4, No. 2, 5-10, 1987.
J. Reed, P. Luedtke, G. Whitten, N. Mahajan, R. Pandey, A. Alam, and S. Pai, Comparative Analysis of Amphotericin B Formulations for its adverse reactions. Presented at the 24th Annual ASHP Midyear Clinical Meeting in Atlanta, Georgia, December 3-7, 1989.
N. Mahajan, A. Alam and S. Pai, Evaluation of Stability of Amphotericin B for Injection using High-Performance Liquid chromatography. Presented at the 48th ASHP Annual Meeting and Exhibit in San Diego, California, June 2-6, 1991.
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