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at Tunnell Consulting
Product/Manufacturing Process: the product is a special type of patch. It is composed of polymeric microneedles that are once coated with an API that is dissolved in a liquid solution. The overall process is essentially a one time dipping of 10 to 15 microneedles in an API solution. The API is completely dissolved. It is not a micro suspension. This is done in a sterile atmosphere. They need to ensure content uniformity and potency. The patch is then punched under the skin with a pen. It remains under the skin for 10 minutes or so, enough time for the drug to be delivered and is then removed. The therapeutic application is for a specific form of osteoporosis.
Their goal is to have the product ready for commercial production in June. There is a lot of work to be done between now and then. They need to scale up the process.
Responsibilities: the responsibilities are of two kinds. The main one is to play the role of technical lead, overseeing the product, process and analytical method development, scale-up and transfer effort. The other responsibility is to perform as a project manager. This requires good interpersonal skills
Skill set requirements:
-strong product development, scale-up, tech transfer background of drug products
-Expertise with complex oral solid dosage forms, especially coating processes. Expertise with patches is not needed as this is not a traditional transdermal patch.
-Project management experience
-Preferably a PhD in pharmaceutical sciences or chemical engineering or mechanical engineering or polymer sciences
-Master’s degree will also be considered with appropriate work experience