Joel Zingerman Email & Phone Number

Carlsbad, Ca, Us

Operate a thriving bio-pharmaceutical consulting practice demonstrating the positive attributes of repeat client business, enthusiastic client referral, and positive project outcomes. Since inception, consulted to over 25 domestic and international companies, with average service duration of over 30 months. Provide small molecule and biologics development expertise from pre-formulation through product launch. Corporate client profiles ranging from 5 to 500 employees, typically pre-commercial.

Established the Manufacturing Technology Group at Agouron to ensure the rapid and successful transition of drug products and technologies from development into commercial production. Hired and managed a staff of six engineers and scientists that held responsibility for all technical aspects of drug product manufacture and late-stage product development. Specific areas of oversight included: product technical transfer, process scale-up and validation, clinical supplies manufacture, packaging and labeling development, manufacturing database design/management, ongoing process improvement, and commercial manufacturing technical support.• Managed the late-stage technical development and commercialization of Viracept® Tablets and Pediatric Oral Powder (an HIV protease inhibitor). Employed quality by design (QbD) principles and implemented process analytical technology (PAT) to ensure Viracept® product quality.• Transferred-in and supported GMP manufacturing operations at facilities located in Palo Alto, Toronto, Puerto Rico, New York, Freiburg, and Basel.• Increased Viracept® drug product manufacturing capacity twenty-fold during a twelve-month period following product launch, in order to meet market demand (1st year production exceeded 500 product batches, over 300 kg each).• Post-launch, chaired the Viracept® Chemistry and Manufacturing Controls (CMC) Team that managed issues ranging from FDA regulatory updates to health and safety evaluation/notification requirements for international commerce.• Provided resources and expertise to five pipeline projects, including an injectable and an aerosol.• Chaired the due-diligence CMC committee for a non-nucleoside reverse transcriptase inhibitor (NNRTI) product licensure.• Earned a merit-based promotion from Manager to Sr. Manager in 1998.

Us

Held positions of increasing responsibility within Parke-Davis Product Development and Manufacturing Operations. Provided technical support for marketed products, new product introductions, and product transfers between manufacturing facilities. Designed and implemented remedial action plans for FDA consent decree products using design of experiments (DOE) and QbD. Reformulated existing products and developed line extensions.Evaluated the performance of novel dosage forms and drug delivery systems including sustained-release tablets and pellets, aerosol formulations, liquid suspensions and emulsions, IV solutions, lyophilized powders, and transdermal patches. Developed and applied solid-state analytical methods to characterize the physical/chemical properties of materials using a variety of analytical instruments. Held positions of increasing responsibility within Parke-Davis Product Development and Manufacturing Operations, having received four merit-based promotions.

Irving, Texas, Us

Evaluated structure/property relationships of polymer blends and composites using optical and electron microscopes. Prepared research reports detailing findings.

Doctor Of Chiropractic

Master Of Business Administration (Mba), Operations Management

Bachelor Of Science - Bs, General Sciences