CMC & Non-clinical expert - Mind blowing Pipeline - Denmark

We are looking on behalf of our client for a CMC and Non-clinical Specialist. The position will be based in Copenhagen Denmark and our client is fully committed to become the best in the industry.

Short Description about your responsibilities:
- As CMC drug development subject matter expert, lead formulation and method development strategies and activities to achieve corporate filing goals.
- Create and implement plans for formulation development including pre-formulation, formulation development, process development and optimization, scale-up and clinical manufacturing.
- Direct third-party contractors, consultants and service providers to deliver CMC and Non-clinical Toxicology and Safety projects according to plan.
- Evaluate new product development opportunities, including leading all R&D due diligence activities, whether internally conceptualized or acquired through collaborations or partnerships.
- Engage in developing R&D plans, budgets and resourcing strategies.

Who will you be working for?
Our client is a privately held, clinical stage, pharmaceutical company dedicated to the development of a compound class with a new mode of action. The company is currently testing two topical products in Phase II for skin infections and atopic dermatitis. The leadership team of our client has invented and developed more than 10 novel medicines that are now approved for human use. In 2017, these medicines saved thousands of lives and generated combined revenues exceeding 5 billion USD. What that means is you will be working with THE PROFESSIONALS, learning, developing and executing world innovating thoughts into action.

Why Blockbuster drug?
One of our client's many drugs has recently successfully finished Phase II of clinical trials and is going to hit Phase III by the end of this year. To give a short explanation of the drug and how it will blow away the industry by storm, we are now going to give you some examples. Let's call it "X" to make it easy.
Daily Use: Competitors- 3 times daily / X - Once Daily
Treatment duration: Competitors - 7-14 days / X - 5 days
Current Resistance levels: Competitors - Med-high / X - None
Effect against MRSA: Competitors - No / X - Yes

For more information about the list, do get in contact with the consultant in charge of this process.

The Requirements:
- MS or PhD in biology, chemistry, or related discipline, with degree in drug development desired.
- 5+ years of experience in managing CMC product development activities in the pharmaceutical industry. Dermal delivery experience preferred.
- Ability to effectively manage an outsourced R&D function, development programs, excellent project management skills with ability to manage and direct multiple projects simultaneously.
- Significant understanding of FDA regulations and international regulatory requirements, CMC methods and non-clinical development.

Take the chance to work for a new Block Buster Pharmaceutical company by sending your CV to Johan Forssell, J.Forssell@nonstop-recruitment.com or give him a call on +45 787 947 40