CMC & Non-clinical Specialist - Blockbuster Drugs Incoming
- Employer
- NonStop Consulting
- Location
- Copenhagen
- Salary
- €50000 - €100000 per annum + Salary is to be negotiated after exp
- Closing date
- Aug 1, 2018
View more
- Sector
- Pharmaceutical, Clinical Project Manager
- Contract Type
- Employee
- Hours
- Full Time
- Organization Type
- Corporate
Job Details
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.
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 Pharma company by sending your CV to Johan Forssell, J.Forssell@nonstop-recruitment.com
Company
Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries.
Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery. Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.
The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors.
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