Manager Quality

NAJMUDDIN KHAJA, Ph D

*** **** ****, *-****:

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

Webster. Texas. 77598 phone: 832

*** ****

SUMMARY OF PROFESSIONAL QUALIFICATIONS

. High achieving staff scientist with 20 years of experience in

Biotechnology industry. Expert in immunoassays development like small

molecules such steroids and as well as good in protein and peptides

immunoassays.

. Excellent knowledge and experience in the clinical drug screening,

quality control, analyzing results and reviewing reports, writing

SOP's and have good hands on GC/MS, LC MS/MS and AU 400 Olympus for

EMIT immunoassay. Few Drug abuse metabolites methods Developed and

validated for drug screening (Benzodiazepine, Opiates, Cocaine,

Amphetamine, Oxycodone, Methadone, SOMA carisoprodol Buprenorphine).

. Extensive manufacturing and research experience in the field of

biochemistry and Bio-inorganic chemistry with 3 international

publications in synthesis of antitumor and anticancer drugs

derivatives.

. Expertise in developing, validating, testing, analyzing, qualifying

and documenting. Enjoy tackling difficult challenges, meeting

deadlines to increase customer satisfaction.

. Excellent immunoassay skills such as designing assays, method

development, trouble shooting products, compliance and validation

under cGMP, ISO 9000 & FDA rules and regulations.

. Background includes depth knowledge of clinical chemistry, analytical

chemistry methods & techniques and immunology system of antigen and

antibodies.

. Strong leader who trained and develop employees and communicates

across departments and meet with staff on a daily basis to improve

professional development and product quality and comply with

compliance. Also participates in CAPA, customer feed back, root cause

finding and helping in QA department with supporting data of study.

Attending meetings like, internal audit and external audit findings

and MRB (material review board) and continuous product improvement

group.

. Proficient Microsoft office skills (Word, Excel, power point

presentations).

PROFESSIONAL EXPERIENCE

Chief of the Laboratory At UCR Labs (August2010 to present)

In charge for All drug screening in urine samples through immunoassay and

confirmation & quantification of analytes by GC/MS and LC MS/MS. Review and

qualify all reports and send it to doctors office with 72 hours of

receiving samples. Responsible for CAP survey proficiency and confirmatory

testing and reporting. Responsible for maintenance & small trouble shooting

of all equipment and calibrations. Very good in writing all sample

extraction and assay procedures and techniques and SOP's. lot of knowledge

of SPE AND LIQUID LIQUID extraction and analytical techniques.

Manager / Staff Technical Operations Scientist At BCI (2005 to August 2010)

ACCOMPLISHMENTS

> Designed, Developed and commercially launched a marker for cardio

diseases. Led to increase company profit and market exposure. Basic

development and characterization of antibodies and dynamic range

donned by me.

> Streamlined key process to trouble shoots and resolves customer

issues. Increased customer satisfaction to over 90%.

> Streamlined inventory process by reorganizing storage using lean

system to increase efficiency and productivity resulted in reduced

costs, reduced back orders for the company.

. Responsible for all activity top 3 product of the company.

. Responsible for conjugate reagent Manufacturing group to supervise and

direct them for building and testing and qualifying conjugate

concentrates reagents for all ELISA and EIA products.

. Analyzed data and approved the bulk reagents and transferring them to

the Q.C and sending to the Dispensing department.

. Heavily involved in the product trouble shooting and improving quality

of the products continuously, attending customer feed back meetings to

improve quality of the products.

. Redeveloped two products (INSULIN ELISA & RENIN IRMA) which improved

their performance and put them back to the customer availability of

product list.

. Closely worked with technical support group to support the customer

needs and improvement in the products quality and performance.

. Participated in the product scale up project to avoid the backorders

and improve the product supply services.

. FDA/ISO 13485/Compliance knowledge: Developed SOP's Calibration and

maintenance records for UV spectrometer plate reader, plate washer,

and chromatographic systems used in protein purification and bio

analytical techniques (HPLC, UV, IR, TLC & Gel columns).

Lab Manager / Product Development Scientist at DSL (2000- 2005)

. More than 10 products developed and transfer for commercialization.

. 5 products redeveloped due to running out antibody and raw material.

. Reestablished and anchored the calibrators and controls against WHO

standards.

. Practical experience in assay converting IRMA to ELISA to

chemilumnicecent assays; modification of HRPO to Biotin-Avidin system

and TMB to luminal substrates.

. Drove the product transferring from R&D to production group for cross

training production people and making pilot batches and running all

verification and validations lots.

. Worked with TAP LAB (Tube and plat coating lab), resolved lot of

issues of products failure and hig CV and NSB. Implemented new methods

to improve the quality and consistency, maintaining of equipment

procedures.

Iodination lab Group Leader at DSL (1991-2000)

. Labeled steroid and peptides and proteins with I-125 radioisotope.

. Tested and built production batches.

. Qualified and transferred, I-125 labeled reagents to the dispensing

department.

. Documented all profiles of iodination's and testing result data to the

document center with all information of raw material used during the

process, according to the GLP/GDP/FDA and GMP rules and regulations.

. Expert in HPLC and other analytical chromatography methods and maintained

all the HPLC system and Gel Columns and keep ready for the next cycle of

Iodination schedule for shipment.

EDUCATION

Osmanic university, India, Biochemistry & Inorganic chemistry, Ph D,1992.

Aligarh Muslim University, India, Inorganic Chemistry, MS, 1985.

Kakatiya University, India, Industrial Chemistry, B.S, 1983.

PUBLICATIONS AND POSTERS

1. "Immunoassay of serine-phosphorylated isoform of insulin-like growth

factor (IGF) binding protein (IGFBP-1)". 2007 : Khosravi Javad; Krishna

Radha G; Bodani Umesh; Diamandi Anastasia; Najmuddin Khaja; Karla Bhanu;

Kumar Ajay. Clinical Biochemistry 2007;40(1-2):659-93

2. "Pitfalls of immunoassay and sample for IGF-1: comparison of different

assay methodologies using various fresh and stored serum samples". 2005 :

Khosravi Javad; Diamandi Anastasia; Bodani Umesh; Khaja Najmuddin;

Krishna Radha G. Clinical Biochemistry 2005;38(7):659-66.

3. "Enzyme-linked immunosorbent assay of total inhibin: direct

determination based on inhibin alpha subunit-specific monoclonal

antibodies". 2004 : Khosravi Javad; Krishna Radha G; Khaja Najmuddin;

Bodani Umesh; Diamandi Anastasia. Clinical biochemistry 2004;37(5):370-6

4. "Pregnancy associated plasma protein-A: ultrasensitive immunoassay and

determination in coronary heart disease". 2002 : Khosravi Javad; Diamandi

Anastasia; Krishna Radha G; Bodani Umesh; Mistry Jehangir; Khaja

Najmuddin. Clinical biochemistry 2002;35(7):531-8.

5. "Synthesis, antimicrobial and antitumor activity of a series of

palladium (II) mixed ligand complexes". B.T.Khan, J. Bhatt, S.

Shamsuddin, K. Najmuddin and K. Annapoorna. J. Inorg. Biochem., 1991,

44(1), 53.

6. "Crystal and molecular structure of cis-dicloroethionineplatinum(II) and

its interaction with adenine, hypoxanthine, cytosine and their

nucleosides". B.T.Khan, K. Venkatasubramanian, S. shamsuddin, k.

Najmuddin and S.M. Zakeeruddin. Inorg. Chim. Acta, 1991, 179, 129.

7. "Mixed ligand complexes of cis-dichlorethioninepalladium (II) with

purines, pyrimidines and nucleosides". B.T.Khan, S. Shamsuddin, K.

Najmuddin and S.M. Zakeeruddin. Inorg. Chim. Acta, 1990, 170, 129.

8. More than 10 posters presented in the American Clinical Chemistry

conference last 15 years with Diagnostic Systems Lab. Inc.

Accreditations and Certifications

1. Positive Employee Relations Employment Law Compliance for Supervisors

&

Managers.

Institute for Applied Management & Law, Inc. (IAML) June 2009

2. Root Cause Investigation for CAPA, A proven technique to investigate &

solve

Technical CAPA problems.

Weaver Consulting, LLC. July 29-30 2008.

3. EPIC Nominee 2009 for Outstanding Performance and Dedicated Service.

Beckman Coulter, Inc.

Immunoassay, Molecular Diagnostics & Genomic

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