Ajmal A. Khan

**** ****** ****, ***, *****

Houston, TX 77004

Phone: 901-***-**** (cell)

E-mail: adz54u@r.postjobfree.com

Linked in URL: https://www.linkedin.com/in/ajmalakhan350

Summary

Regulatory Affairs

Authored CMC sections (Module 3). Prepared Briefing Books for FDA pre-NDA meetings. Took leading role in pre-approval inspections (PAI). Authored Module 2 Quality Overall Summary (QOS). Worked on NDA and ANDA submissions. Currently working on ANDA submissions on several products.

Drug Device Combination Products

Authored CMC and sterile process validation sections for the combination products Cardizem Lyoject® Dual Chamber Syringe and Cardizem Monovial® iv infusion. Led the PAI inspection Team. Both the products were approved on schedule.

Nasal Spray/Auto Injector Experience

Developed a range of Oxymetazoline decongestant nasal spray products. Include Pumps and squeeze bottles.

Claritin Chewable Tablets (Non-sedating antihistamine). NDA

Authored CMC sections. Led the Pre-approval inspection. Addressed FDA questions.

Zegerid Capsules (Omeprazole Proton Pump Inhibitor/Sodium Bicarbonate combination) NDA. Rx to OTC switch.

Authored CMC sections, prepared briefing book, attended pre-NDA meetings with FDA.

Container-Closure/DMF experience

Developed Container Closure integrity testing procedures. Experienced in extractable/leachable testing on container/closure systems.

NDA Drug Device Experience

Played leading role in NDA submission of the drug/device products Cardizem Lyoject® and Cardizem Monovial®.

US Regulatory Intelligence Up to date on FDA guidance documents, and use of other FDA resource items such as Orange Book and IID database.

Project Leadership

Project Leader for the RX to OTC transfer of Zegerid Heartburn product. Directed the process development and validation for sterile (aseptic fill and terminally sterilized) and non-sterile products. Highly experienced in technology transfer and manufacturing technologies for all types of pharmaceutical dose forms.

Experience

LGM Pharma, Rosenberg, TX 2019-Today

Principal Investigator

Currently working on projects in areas of formulation, process development and technology transfer of liquid and semi-solid oral and topical dosage products. Include CMC preparation, GMP and GLP, quality control and manufacturing and microbiological preservation.

Nexgen Pharma, Rosenberg, TX 2016- 2018

Principal Investigator

Headed the Texas R&D Group for formulation, process development and technology transfer to manufacturing for OTC and Rx generic products. Played a leading role in the preparation and regulatory submission and approval on several ANDA’s.

Bayer Consumer Care (Previously Merck Consumer Care and Schering Plough Healthcare, Memphis, TN 1997- 2015

R&D Global Pipeline Development Leader 2011-2015(Merck Consumer Care)

Partnered with the Global Franchise Marketing partner on the development of global pipeline of products and product claims. Managed the planning and coordination of the new product development.

Research Fellow, Pharmaceutical Development: 2003- 2011(Schering Plough Healthcare)

Developed formulations of new products and technology transfer to manufacturing. Extensive experience on semi-solid, solid and liquid dose forms. Brands worked on include Claritin, Coppertone, Solarcaine and Dr.Scholl’s. Team Leader of cross-functional Teams for product development of monograph and NDA products. Project Team Leader for the Rx to OTC switch and launch of Zegerid® G.I. product for heartburn.

Director, Process Development and Technology Transfer: 1999 -2003(Schering Plough Healthcare)

Directed the development and transfer of manufacturing processes to Production and third-party manufacturers. Additional responsibilities included coordination of GMP training and audits of R&D areas and providing technical support to Operations. Directed Technology Transfer Teams to smooth transition of new products into Manufacturing.

Director, Process Development and Validation: 1997-1999 (Schering Plough Healthcare)

Headed the Process Development, and Validation Department. Co-ordinated a site rationalization project for transfer of several products manufactured at the Schering Plough Memphis site to alternate Schering Plough sites and contract manufacturers.

Hoechst Marion Roussel, Marion Merrel Dow, Merrel Dow (now Sanofi/Aventis) 1984- 1997

Research Scientist and Project Team Leader: 1993-1997 -Hoechst Marion Roussel, Kansas City

Project Team Leader, providing supervision to 14 Formulations/Process Scientists. Directed activities of cross functional teams to successful filing and approval of new products in the USA and other countries. Specific area of responsibility included sterile and non-sterile liquid, semi-solid and solid dosage products. Project Team Leader for two injectable drug/device products incorporating the Vetter Lyoject® and Becton Dickinson Monovial® injectable delivery systems. Both the products Cardizem Monovial® and Cardizem Lyoject® are on the market.

Group Leader: June 1992 to June 1993- Marion Merrell Dow (MMD), Kansas City

Responsible for 7 associates. Major activities include product transfer from MMD to Smith Kline Beecham. This work was done following an OTC product partnership formed in 1992 between Marion Merrell Dow and Smith Kline Beecham.

Head Product Development: 1991-1992 (Marion Merrell Dow, Cincinnati)

Reported to the Head of Rx R&D with direct reporting relationship to the President of the Consumer Product Division. Transferred from the Canadian Subsidiary Company Merrell Dow Pharmaceuticals in Toronto.

Manager Product Development: June 1984 to April 1991 (Merrell Dow, Toronto, Canada)

Primary responsibility for formulation development and technology transfer of sterile and non-sterile manufacturing processes. Promoted in 1991 to head a newly formed OTC Product Development Department based in Cincinnati.

Research Scientist: Research Foods Limited, Toronto, Canada 1980-1984

Worked on a project sponsored by the National Research Council of Canada on extraction and characterization of fungal toxins on Canadian grain products. Additional responsibilities included chemical and microbiological testing of food and pharmaceutical products.

Manager Sterile Production: Burroughs Wellcome and Company, Karachi, Pakistan 1977-1980

Responsible for the manufacture of sterile products for the company, as well as contract manufacture of sterile products for Alcon and Astra. Products included both terminally sterilized and aseptic filled products, small volume vials and ampoules and large volume parenteral products.

Education

University of Manchester, Manchester, U.K. Ph.D. Pharmaceutics. Microbiological Quality Control of Gamma Radiation Sterilization. 1977

University of Karachi, Pakistan. MSc. 1972. Majored in Microbiology and Biostatistics.

Publications/Posters

Development of a Container Integrity Test for Cardizem Monovial injectable. A.A.Khan and M.T.Kenny.

Poster, 1996 AAPS Annual meeting. Seattle, October 31-November 4, 1996.

Measurement of Force Required to Move the Plunger in Glass Syringes Using the Instron. O.Henderson,

A.A.Khan and A.Gayed. Poster, 1994 AAPS Annual meeting. San Diego, November 6-10, 1994.

Marion Merrell Dow: A team case study of inter company and inter functional cooperation. S.K.Evans,

S.W.Tobey and A.A.Khan. Speeding New Products to Market: Best Practices and Effective Teamwork.

Symposium jointly sponsored by the Marketing Institute and Product Development and Management

Association. Chicago, March 23-24, 1992.

Semi-automated Aqueous Film Coating of tablets Using High Solids Ethylcellulose Dispersions. A.A.Khan and M.N. Grimshaw. Sci-tec. 1989. Conference sponsored by the Dow Chemical Company, Sarnia, Canada, April 28-29, 1989.

The Sub-Process Dose in Defining the Degree of Sterility Assurance. A.Tallentire and A.A.Khan.

Johnson and Johnson International Conference on Radiation Sterilization. Vienna, April 2, 1977.

Microbiological Quality Control of Sterilized Products. A.A.Khan, A.Tallentire and J.Dwyer. Verification

of a Model Relating the Frequency of Contaminated Items and Increasing Radiation Dose.

J. appl. bact. 43:1977 p205-213.

Tests of the Validity of a Model Relating the frequency of Contaminated Items and Increasing Radiation Dose.A. Tallentire and A.A.Khan. Radiosterilization of Medical Products 1974. p3-14. IA

Teaching Assignments/Presentations/patents

George Brown College, Toronto, Canada (1987) - Part-time instructor (evenings) in Biology.

Seneca College of Technology, Toronto, Canada (1987-1990- Part-time instructor (evenings) teaching a course leading to “Industrial Pharmaceutical” Technologist certificate.

University of Alberta, Edmonton, Canada (1988). Invited Lecturer, for pharmaceutical manufacturing to final year pharmacy students.

University of Tennessee, Memphis (1997). Adjunct Associate Professor in the Department of Pharmaceutical Sciences. Collaborated in teaching a postgraduate course in Parenteral Sciences. Topic “Validation of Sterilization processes”.

University of Mississippi, Oxford, MS (1997). Invited Lecturer. Advances in convenience packaging for parenteral products.

University of Mississippi, Oxford, MS (1998). Invited Lecturer. Tablet compression theories.

University of Memphis, Memphis, TN (2001). Invited Speaker. Workshop Feb 10, 2001. Free radicals and Biomaterials: Cross-Link vs. product deterioration. Title of presentation: Contaminated items and radiation sterilization- A dose-response model

University of Memphis, Memphis TN (2011). Invited lecturer. Advanced Physics Course. “Radiation Sterilization of Pharmaceutical Products”

AAPS Student Chapter, Dept of Pharmacy, University of Tennessee, Memphis TN (2006)

Invited speaker. Technology Transfer Challenges in Pharmaceutical Manufacturing.

Chewable tablet and Method of Formulating. US patent # 200-***-**** EU patent # 07862797.3-2112

Special Achievement Awards

Seneca College Dean’s Award 1990: Dedication to program area: Pharmaceutical Sciences.

Marion Merrell Dow R&D President’s Special Achievement Award, 1992.

Marion Merrell Dow R&D President’s Special Achievement Award, 1994.

Hoechst Marion Roussel R&D President’s Special Achievement Award, 1996.

Recipient of scholarship given by the U.K. Panel on Gamma and Electron Irradiation. Developed and validated a mathematical model for microbiological control of radiation sterilization. Postdoctoral work at the University of Manchester in the same area of research.

Professional Societies

American Association of Pharmaceutical Scientists (AAPS)

Citizenship

US

References

Will be provided on request.

Hobbies

Tae-Kwon-Do (First degree black belt), Music (Playing Guitar)

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