Chief CMC specialist - small molecules

CMC and Non-Clinical Specialist

Do you want to work with the top talent that Denmark has to offer? Do you want to be part of a revolutionary company there is looking to become the next big player?

We are currently working exclusively with a fast-growing biotech company, there are working with cutting-edge technology's, that means that you will be at the forefront of the most exciting developing that Denmark has to offer!

You will be the strategic responsibility for bringing the coming Game-changing and potential Blockbuster product to life and you will be there from the start, so you can grow with the company and put your mark on it as it grows.

Reporting to the CSO, the CMC and non-clinical specialist will be responsible for developing and executing Non-Clinical Toxicology and Safety and CMC Development strategies from conception through to commercialization.

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.
• Work with other functional groups to develop processes to streamline, track and monitor drug development activities.
• 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.
• Work with Regulatory Affairs to provide needed CMC/non-clinical input for FDA/Regulatory Agency various functional areas to achieve timelines and to ensure that company goals are integrated into development activities.
• Duties in addition to what is defined above should be expected.

Qualifications:

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

If you are interested, then get in touch with, Casper Skyum Hogh by applying to this add with your CV in a word format

I am a specialised recruiter within Regulatory in the Pharma, Biotech and Medical Device industry. I, therefore, have access to an extensive network within these industries, which aren't available otherwise. If the above opportunity doesn't have your interest, but you would like to hear more about potential opportunities, then you are welcome to contact me for a noncommittal, confidential chat.

If you know someone in your network who may be interested in the above, then you are more than welcome to pass on my details to them, so that I can be of assistance to them.

NonStop is one of the largest and fastest growing specialised life-sciences & Med-tech recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic, and we hold labour leasing licences for all EU8 countries. Please visit our website for a full list of the niche markets we cover.