Director CMC & Regulatory Affairs Stayble Therapeutics

Job description
This is a great opportunity to join an exciting start-up company. We are looking to broaden our team with a Director of Chemistry, Manufacturing, Control (CMC) & Regulatory Affairs. The person will take a key strategic role in the management team. The Director of CMC & RA will be a fourth cornerstone in the management team of Stayble. 

As an employee with Stayble, you receive a competitive salary, benefits and flexible working hours. We are looking for an employment of between 60 - 100%. Please indicate if you would like to work full-time or part-time in your application. 

Responsibilities
The overall responsibility is to lead all CMC and RA work for Stayble’s phase IIb asset STA363 in chronic low back pain. Responsibilities include to lead key strategic decision-making related to the final product, to source necessary CMO capabilities for phase III and commercial supply, to address QA/QC matters and to prepare interactions with Competent Authorities. The role is broad with responsibility to procure required services and expertise externally. To succeed in this role, we believe it is vital to have experience within small molecule CMC, procurement of CMO services and an overall understanding of regulatory requirements and procedures. In addition, it is important to be analytical and structured and to possess excellent project management skills. 

Stayble is a small biotech company and you will be joining a diverse and adventurous team with a high pace and willingness to take the company to the next level. As a person you should be driven, analytical and prestigeless. We encourage contrasting opinions in order to optimize decision-making and the future development of Stayble. We are committed to make a difference for patients and a positive impact on world health. 

Qualifications
A minimum of 5 years’ experience of working in the pharmaceutical industry, in similar roles. 
Experience with the IMPD and the IND formats, and the requirements on Drug Substance and Drug Product over the course of development. 
Experience in sourcing CMO services and interacting with Competent Authorities. 
Previous experience from working with parenteral solutions is an advantage.

We welcome all qualified applicants and strive for diversity.

Application
Please apply via Randstad’s webpage by 2021-02-25 at the latest. Selection and interviews will be performed continuously and the position may be filled before the last day of application, therefore, we encourage you to apply as soon as possible.

In this recruitment Stayble Therapeutics collaborates with Randstad Life Sciences. 
For more information please contact Birgitta Nyström (Consultant manager) birgitta.nystrom@randstad.se or Eleonor Ehrman (Talent manager) +46733434109.

About the company
Stayble is a clinical stage biotech company developing the injectable treatment STA363 for disc-related low back pain. The treatment is aimed at patients whose back pain persists after physiotherapy and painkillers. The injection is given once. The effect is expected to remain throughout the entirety of the patient’s life and to require minimal rehabilitation. The Company’s focus is set upon the continued clinical development of the ongoing phase 2b trial. Stayble’s vision is to develop STA363 as a new standard of care for patients suffering from chronic disc-related low back pain.