Atlas Pharma
09/2016 – Present
Contract Manager
- Coordinates planning and construction phases of a new overseas plant for the manufacture of pharmaceutical drugs to be distributed in the US.
- Reviews construction progress to ensure that the plant complies with FDA regulations and contract terms.
- Researches and selects new plant equipment for washing, blending, filling, and packaging, and negotiates contracts with suppliers.
- Monitors the manufacture of equipment under contract and authorizes progress payments, adjustments, and waivers to suppliers.
- Ensures that manufacturing equipment arrives at the site as required by construction schedule.
- Coordinates the calibration of manufacturing machinery, quality control equipment and laboratory instrumentation to ensure compliance with contracts and specifications, and signs off on closeout documentation.
TMS Health
11/2015 - 08/2016
Product Manager - Insulin Delivery Device
Managed the introduction of a new insulin delivery device to the US market.
- Developed and managed annual department budget of $7.2 million for introduction and distribution of a new insulin delivery device in the USA.
- Negotiated contracts with regional distributors and monitored their performance.
- Prepared weekly device reliability reports and discussed remedial action with the FDA whenever needed.
- Trained product representatives and directed their presentations to physicians and nurses.
- Coordinated travel schedules for sales reps nationwide.
- Wrote product literature.
- Planned and managed conferences and education programs for healthcare providers- Implemented and managed a logistics program to ensure product availability at distribution centers and pharmacies.
TMS Heath
01/2014 - 10/2015
Manager-Combivent Respimat Inhaler South East
Managed the introduction of a new medical inhaler in the south east USA.
- Developed and managed a $5 million budget for the introduction of new drug product and medical device in the South East United States.
- Trained and managed 12 product representatives.
- Directed representative's travel to conduct seminars at medical centers and hospitals.
- Negotiated with insurance companies the inclusion of the product in formularies, promotion, and patient support programs.
- Prepared and submitted product reliability reports for the FDA.
Atlas Pharma
05/2005 - 12/2013
Assistant Project Manager
Duties are related to contract manufacturing of pharmaceuticals produced overseas for distribution in the
USA.
- Review documentation related to materials used in the manufacture of drug products to ensure that their origin, production, handling and packaging were United States Pharmacopeia certified, compliant with FDA specifications and conformed to the contract.
- Ensured that calibration of the production machinery, the quality control equipment and the lab instrumentation were up to date, that the equipment was performing as required and that all validations were completed on schedule.
- Met with Department Managers at the manufacturing plant and reviewed plant records to ensure that manpower training and operating procedures complied with FDA requirements and with the manufacturing contract terms.
- Ensured that production schedules and the flow of materials in the manufacturing process allowed the timely delivery of produc...
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