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Microbiology Laboratory

Location:
Okemos, Michigan, United States
Posted:
March 20, 2019

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Resume:

M. Iqbal-resume

* ** *

Manzoor A. Iqbal **** Jo Pass,

East Lansing, MI 48823.

847-***-****

ac8un5@r.postjobfree.com

Objective: Seeking a challenging position where I can utilize my education and experience in Microbiology Quality Control, Method Development, Validation, Teaching, Training and Quality Assurance to join and become a member of a progressive scientific team; contributing to the profit, development, and welfare of the organization. Summary: I’ve worked in the capacity as a microbiologist, validation specialist, supervisor and manager of a Microbiology laboratory. I have been involved in nearly every aspect of microbiology analytical testing in the pharmaceutical industry, consumer care industry and clinical bacteriology laboratory. Introduced new methods, assessed, improved and validated the existing test methods to meet compendial and regulatory requirements. Taught and trained the current and new employees the concept and technology used in Industrial Pharmaceutical Microbiology quality control and manufacturing. Purchased new equipment and implemented Rapid Microbiology Methods in the laboratory for cost saving and reduction in turnaround time per test based on the risk assessment and QbD of the test method.

Work Experience:

10-2017 to 11-2018 Fresenius-KABI, Grand Island, New York, Manager, QC Analytical Microbiology Laboratory.

Managed two supervisors, three associated supervisors and seventeen microbiologists of the analytical microbiology laboratory.

Ensured that the microbiological testing is performed accurately according to the company’s SOP in compliance with the pharmacopeial, FDA and European regulatory requirements, and results are released in a timely manner.

Ensured test methods are validated due to new formulation, new material, new components or process change on a timely manner meeting the regulatory requirements. Sterility test method, microbial enumeration and recovery test method and bacterial endotoxin test methods. Ensured QC microbiology laboratory is in compliance with cGMP, cGLP and the regulatory requirements. Performed internal audits of the laboratory and manufacturing area; recommended changes to reduce and control microbial contamination. Analysts were introduced to Gemba walk and 5S concept application to reduce personal and documentation errors.

Introduced a test method evaluation document, including: test method, compendial and regulatory assessment, QbD assessment, risk assessment, test method validation and training (skills assessment). Introduced the training of current and new employees the concept and technology used in Industrial Pharmaceutical Microbiology quality control and manufacturing. Conducted laboratory investigations due to deviations, OOS or environmental excursions and completed laboratory investigation, change control or CAPA.

Designed and executed a new training program.

8-2008 to 11-2016 Emergent BioSolutions, Lansing, Michigan, Specialist 1, QC Microbiology Laboratory.

Supervised the microbiology laboratory as assigned by the supervisor. Ensured that the microbiological testing is performed accurately according to the company’s SOP in compliance with the pharmacopeial, FDA and European regulatory requirements, and results are released in a timely manner.

Maintained QC microbiology laboratory in compliance with cGMP, cGLP and the regulatory requirements. Validated existing and new microbiology test methods meeting pharmacopeial requirements. Purchased Rapid Microbiology Method equipment, Vitek 2 Compact for microbial identification and MicroCount for microbial enumeration and identification. Performed IOQ & PQ of the equipment, developed new methods and validated them.

Troubleshoot laboratory and manufacturing area microbial contamination incidents. Performed internal audits of the laboratory and manufacturing area; recommended changes to reduce and control microbial contamination.

Represented QC Microbiology department as a member of the Regulatory Surveillance team to assure in compliance with the upcoming compendial and regulatory changes and requirements. M. Iqbal-resume

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Environmental Monitoring of the sterile manufacturing area, recommended changes to reduce and control microbial contamination.

Introduced and maintained a library of the environmental isolates; making a tool for microbial ID trending, for quick reference during investigation and for the training purposes. Introduced a test method evaluation document, including: test method, compendial and regulatory assessment, QbD assessment, risk assessment, test method validation and training (skills assessment). Introduced the training of current and new employees the concept and technology used in Industrial Pharmaceutical Microbiology quality control and manufacturing. Conducted laboratory investigations due to deviations, OOS or environmental excursions and completed laboratory investigation, change control or CAPA.

Ordered laboratory supplies and equipment.

Designed and executed a new training program.

1-2007 to 8-2008 Advocate Health Care, Rosemont, Illinois, Med. Tech, Microbiology Laboratory.

Receiving and log-in all clinical specimens in the computer system. Set-up tests for all the routine and special clinical specimens. Performed Isolation and identification of pathogenic microorganisms, stat stains, Rapid tests, API, Parasitological testing, Rapid testing BCAG, Campylobacter, Legionella and Strep tests. Called hospital doctors, floor and commercial clients with positive test results. Performed identification of the CAP survey organisms for two years. 8-2005 to 9-2006 Morton Grove Pharmaceuticals, Inc. Morton Grove, Illinois, Supervisor, QC Microbiology Laboratory.

Supervised the microbiology laboratory, coordinated daily activities, set goals and conducted annual performance evaluation.

Hired and trained new laboratory personnel.

Ensured that the microbiological testing is performed accurately according to the company’s SOP in compliance with the pharmacopeial and FDA regulatory requirements, and results are released in a timely manner.

Maintained QC microbiology laboratory in compliance with cGMP, cGLP, and the regulatory requirements. Reviewed test reports performed for microbial limit testing of water, raw material and finished product, Antimicrobial Preservative Effectiveness Test, antibiotic bioassay of raw material and finished product, Reviewed performance of growth promotion and sterility testing of the test media used in the testing. Supervised and evaluated environmental monitoring of the non-sterile manufacturing, filling and testing area.

Troubleshoot laboratory and manufacturing area microbial contamination incidents. Performed internal audits of the laboratory and manufacturing area; recommended changes to reduce and control microbial contamination.

Conducted laboratory investigations due to deviation, OOS or environmental excursions and complete reports.

Ordered laboratory supplies and equipment. Determined and established the standing orders for each year.

10-1998 to 7-2005 Bayer Corporation, Shawnee Mission, Kansas, Supervisor, QC Microbiology Laboratory.

Supervised the microbiology laboratory, coordinated daily activities, set goals and conducted annual performance evaluation.

Hired and trained new laboratory personnel.

Supervised and coordinated the training of the transfer product test methods. Ensured that the microbiological testing (TMC of water, raw material, packaging material and finished products. LAL testing of water, raw material, packaging material and finished products) is performed accurately according to the company’s SOP in compliance with the pharmacopeial and FDA regulatory requirements, and results are released in a timely manner. Developed and validated the test methods for new finished products and raw materials meeting the pharmacopeial and regulatory requirements.

Was on the team for designing the new microbiology laboratory; assisted in validating the new and existing equipment after moving into the new microbiology laboratory area. Modified the designed the half suite rigid wall Isolator workstation and helped complete IOQ & PQ. Validated the sterilization process of the aseptically filled and sealed vials. Maintained cGMP, cGLP, and the regulatory compliance in the Microbiology QC laboratory. M. Iqbal-resume

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Generate and execute the Cleaning Validation Protocols. Purchased and performed IOQ & PQ of the Chromogenic Endosafe equipment for LAL testing and Vitek Sr. for microbial identification.

Supervised, trained and evaluated the environmental monitoring of the sterile filling area, sterility testing suite and Isolator work stations.

Supervised, trained and evaluated the sterility testing of raw material and finished products. Modified, improved and validated the sterility test method for a highly alkaline antibiotic product using B&F test procedure.

Troubleshoot laboratory and manufacturing area microbial contamination incidents. Performed internal audits of the laboratory and manufacturing area; recommended changes to reduce and control microbial contamination.

Recommended changes for the preparation of liquid media for media fill by heating media up to 80 C for 1 2 hour to reduce microbial contamination.

Conducted laboratory investigations due to deviation, OOS or environmental excursions and complete action document.

Designed and executed new employee training program. Introduced the training of current and new employee the concept and technology used in Industrial Pharmaceutical Microbiology quality control and manufacturing.

Ordered laboratory supplies, equipment and established the standing orders for each year. Developed the cost saving program.

11-1994 to 10-1998 Ferndale Laboratories, Inc., Ferndale, Michigan, Microbiology Validation Specialist.

Validated the existing and new microbiology test methods for TMC. Established validation protocols and wrote reports for the manufacturing and laboratory equipment and the test methods.

Validated WFI water system and recommended changes to improve performance of the WFI system. Generated and executed the Cleaning Validation Protocols. Supervised and evaluated the environmental monitoring of the non-sterile manufacturing and packaging area.

Troubleshoot laboratory and manufacturing area microbial contamination incidents. Performed internal audits of the laboratory, manufacturing and non-sterile packaging area; recommended changes to reduce and control microbial contamination. 11-1989 to 10-1994 Pennex Pharmaceuticals, Inc., Morton Grove, Illinois, Microbiology Laboratory Supervisor.

Supervised Microbiology Laboratory.

Validated the existing and new microbiology test methods meeting Pharmacopeial requirements. Performed and ensured that the microbiological testing (TMC of water, raw material, packaging material and finished products, APE, antibiotic bioassay) is performed accurately according to the company’s SOP in compliance with the pharmacopeial and FDA regulatory requirements, and results are released in a timely manner.

Maintained cGMP, cGLP and the regulatory compliance in the QC microbiology laboratory. Redesign the USP PW system and validated to ensure that it is meeting the compendial and regulatory requirements.

Developed a Microbial Evaluation Plan that was submitted to FDA to defend the Class III recall. Performed Minimum Inhibitory Concentration Test (MIC) for preservative systems in product development.

Modified and Validated the Nystatin suspension and raw material antibiotic USP bioassay test method. Validated the Erythromycin suspension and raw material antibiotic bioassay test method. Troubleshoot laboratory and manufacturing area microbial contamination incidents. Conducted laboratory investigations as a result of deviation, OOS and complete action document. Ordered the laboratory supplies and equipment.

6-1987 to 11-1989 Biocraft Laboratories, Waldwick, New Jersey, Microbiology Laboratory Supervisor.

Supervised and performed the annual cleaning activities for removing Penicillin residue to a safe level. Ensured testing is performed accurately according to the company’s SOPs in accordance with pharmacopeial and FDA regulatory requirements and are released in a timely manner. Generate and executed the Cleaning Validation Protocol, “To reduce the Penicillin residue from the manufacturing facility and equipment down to a safe carry over of non-allergic level into the next product”.

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Performed and trained to perform microbial limit testing of water, raw materials and finished product, APE testing, antibiotic and vitamin bioassay testing and MIC testing for preservative systems in product development.

Modified and Validated the Nystatin antibiotic USP bioassay test method. Troubleshoot laboratory and manufacturing area microbial contamination incidents. Developed and worked on the TLC bioassay method for detecting Penicillin residue. Ordered laboratory supplies and equipment.

4-1983 to 5-1987 University of Illinois Hospital, Chicago, Illinois, Med Tech I, Microbiology evening supervisor.

Supervised Clinical Microbiology laboratory second shift. Receiving and log-in all clinical specimens in computer system. Put on test all the routine and special clinical specimens. Performed Isolation and identification of pathogenic microorganisms. Performed stat stains, CIE test, Phadebact test, Cryptococcal antigen test, India ink stain, API, RapNF, Micro ID and Vitek identification testing.

Performed sensitivity testing by Kirby-Baure method. Trained part-time employees and Med Tech students. Reported stat and routine tests requested by the Doctors. 5-1981 to 4-1983 Cook County Hospital, Chicago, Illinois, Med Lab Tech II, Microbiology. Receiving and log-in all clinical specimens in computer system. Put on test all the routine and special clinical specimens. Performed Isolation and identification of pathogenic microorganisms. Performed stat stains, India ink stain, API, and Vitek identification testing. Performed sensitivity testing by Kirby-Baure method. Reported stat and routine tests requested by the Doctors. 10-1980 to 5-1981 Cook County Hospital, Chicago, Illinois, Med Lab Tech I, Hematology. Receiving and log-in all clinical specimens in computer system. Put on test all the routine and special clinical specimens. CBC using Coulter counter and differential count manually and using Hematrak. Performed Sedimentation and Coagulation testing.

Reported stat and routine tests requested by the Doctors. 12-1978 to 4-1980 Winthrop, Sterling Products Pakistan Ltd, Karachi, Pakistan, Supervisor Microbiology Laboratory.

Supervised Microbiology Laboratory and coordinated daily activities. Hired and trained new laboratory personnel.

Ensured testing is performed accurately according to the company’s SOPs in compliance with pharmacopeial requirements.

To assure microbiological testing is performed, completed, reviewed and released in a timely manner. Developed microbiology testing procedures and test methods for new finished products and raw materials meeting the GMP and Pharmacopeial requirements.

Microbiology laboratory was redesigned to add controlled testing area. Generated and executed the Cleaning Validation Protocols. Performed and trained to perform microbial limit testing of water, raw materials, bulk and finished product, packaging material and performed the environmental monitoring of the testing area. Troubleshoot laboratory and manufacturing area microbial contamination incidents. Performed internal audits of the laboratory, manufacturing and non-sterile packaging area; recommended changes to reduce and control microbial contamination. Conducted laboratory investigations as a result of OOS and completed reports. Ordered the laboratory supplies and equipment.

Research Projects:

● “Microbial Evaluation Master Plan”

● "To study talc microbial flora and the change in the talc microbial flora after sanitization with Ethylene Oxide gas bag method".

● "Comparison of culture media TSA to R2A at different incubation temperatures and different incubation times for the maximum recovery of bacteria from deionized water".

● "Comparison of culture media PDA+ to SDA to use as selective medium for the recovery of Mold and Yeast count".

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● Proposed change to the USP/CFR Nystatin bioassay test method; “To change from high speed blending to high speed magnetic stirring of the first dilution to perform Nystatin bioassay of raw material and drug finished product”.

● Proposed improvements and reconfigured the water system to produce USP WFI.

● Sterility test method for an antibiotic injectable with high alkaline pH was modified and improved to recover all the test organisms and validated using the Bacteriostasis and Fungistasis test procedure.

● Study of the cleaning reagent CIP 200 for the disinfection of Corynebacterium sp.

● Study the susceptibility of Bacillus anthracis strains to different antibiotics.

● Validation and implementation of Vitek 2 Compact and MicroCount Systems in the QC Microbiology Laboratory.

Article:

● "Role of sterilization and preservative system in the manufacturing of non-sterile quality products". Education:

● M.Sc (equivalent to BS) Microbiology (Clinical & Industrial), Minor - Biochemistry and Physiology

● Post graduate courses - General Bacteriology, Microbial Genetics

● Course in personal computer

Membership & Certificate Program:

● American Society for Microbiology.

● Microbiology quality control of the water based products. IACET, New Jersey 1991.

● 5th Annual WaterTech Conference. Ultra Pure Water, Texas, November 1995.

● Microbiology Control and Validation. IACET, New Jersey, March 1997.

● 4th Annual Cleaning Validation Conference. Princeton, New Jersey, October 1997.

● Introduction to Pharmaceutical Microbiology. Kansas, 2002.

● Microbiology Control and Validation. Chicago, 2003.

● The 2003 USP Microbiology Updates & Dissecting USP Chapter <1227> Validation of Microbial Recovery. Kansas, 2003.

● AUDITS 102, Association for the Use and development of Isolators for testing the Sterility. Chicago 2003.

● Microbiology Control and Validation. A three day workshop at York College, New York 2006.

● PMF Open Conference on Compendial Advances – Participating in Change, Philadelphia 2010.



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