Black Swans Exist
Position: Vice President of CMC
Location: Copenhagen, Denmark
Company: Antag Therapeutics
About Antag Therapeutics:
Antag Therapeutics develops cutting-edge therapeutic peptides for treating metabolic and cardiovascular diseases. Based on world-leading research, the company aims to deliver novel peptide-based treatments to address unmet medical needs.
Role Summary:
The VP CMC will, reporting to the CEO, lead the development and manufacturing of pre-clinical and tox- projects and into the clinic.
They will develop and implement strategic process development plans and provide guidance and oversight to CDMOs/CROs and other service providers.
The VP CMC will maintain accountability for the CMC package and Technical Operations plans and CMC-related sections in regulatory filing, and manage resources, budgets, contracts and external relationships necessary to the effective functioning of the group.
They will work in close collaboration and secure coordination and communication with all other functional areas of the company to deliver CMC package Ensure adherence to regulations and applicable guidelines (ICH, GMP, ISO, etc.)
Qualifications:
- M.Sc. in chemistry/pharmaceutical engineering, ideally PhD
- 10+ years of CMC development experience across all stages of development, including for pre-clinical and clinical development
- Proven experience peptide manufacturing as well as parenteral formulation are highly desirable Regulatory expertise and experience writing submissions, regulatory stakeholder interaction and understanding requirements
- Proven experience with management of third-party CDMOs/CROs and service providers
- A strong practical business mindset in terms of cost of development, cost of goods and market value for activity
- Experience with the device would be highly desirable
- In-depth knowledge of cGMPs and familiar with US and EU regulations and quality standards applicable to build CMC dossier (IND and NDA) for regulatory submissions
