CMC Project Director, Synklino / 1760 7CLOSED

The Company
Synklino is an ambitious privately held biotech company located in Charlottenlund, Copenhagen. Synklino was founded in 2017, and has a drug candidate; SYN002, for treatment of CMV in transplantation patients, which is in development, as well as a technology platform for targeting chronic virus infections. See more at https://www.synklino.com/

Synklino is developing their first drug candidate, SYN002, for treatment of CMV infection in transplant recipients. To help them, you will have a unique opportunity to be part of an entrepreneurial culture working together with talented and competent senior colleagues, in their endeavors to improve lives of transplant patients through science. On behalf of Synklino, Best Talent is now looking for an experienced and motivated candidate to reach their goals.

CMC Project Director

Engaged & development oriented

Ambitious, strong & valuable anti-viral Biotech company
CMC management and execution of CMC related activities
A challenging job with great influence and impact on decision making

The Challenge
Do you think strategically, and can you act operationally? Would you like a unique opportunity to take part in building a strong and valuable anti-viral Biotech company heading for an IPO?

Synklino recently initiated development of the first drug candidate and has initiated CMC development at a European CMO. You will be responsible for CMC management and successful execution of CMC related activities. This includes oversight of out-sourced activities related to GMP manufacture of DS and DP, stability studies and product characterization, as well as IMP manufacture and clinical supply. You will have the support of subject matter expert consultants, as well as in house expertise in process development and analytical development.

Synklino is working as a fully virtual company with all activities outsourced, and as CMC Project Director you are the natural key player in the CMC development activities.

You are a genuine team-player and will collaborate closely with multiple disciplines at Synklino, including clinical development and non-clinical development. You will also work closely with QA in establishing a QMS suitable for the stage of development, Synklino is in.

You will have a significant influence and will play an important role in setting and executing on the overall development strategy in collaboration with other senior employees and executive management.

Synklino is establishing a discovery platform and as the CMC Project Director you will work with Head of Discovery and Head of Pharmacology, contributing to a strategy for lead selection, and ensuring developability of drug leads for new projects.

Synklino offers a challenging and versatile job in an innovative, fast paced, flexible, well-organized, and committed biotech environment with a high degree of influence and opportunity for personal and professional development. You will report to the Chief Operating Officer.

Your Talent
You have an academic degree within a relevant area. You have experience with general CMC development strategy, a good understanding of GMP, and experience with pharmaceutical development of parenteral biopharmaceuticals. You are excellent at project management and have the ability to define the outsourcing strategi and select the right vendors. You can execute on day-to-day project management, as well as working at a higher level through work on steering committees and in inhouse strategic fora.

You are able to work effectively with other disciplines, including clinical development, toxicology and QA to collectively ensure timely IND/CTA submission, and supply for clinical trials. You have direct experience with IND/CTA documentation, including writing module 3 of INDs and IMPDs. Experience with late-stage development is preferred, but not a requirement.

As a person you are a self-driven, creative, structured, and an accountable team player with humor. You are positive, committed, and full of drive. It is important that you are focused, can prioritize, and keep calm when deadlines are tight. You are good at solving problems and thrive with a well-balanced workload and with a good work life balance. You are fluent in Danish and English, both written and spoken. In other words, you have the desire to support and enrich Synklino’ s culture and would love to work in a biotech company.

Application
Best Talent is responsible for the recruitment process at Synklino and reviews your application on a confidential basis. Forward your application including your CV in English marked”1760/CMC Director” by e-mail to job@besttalent.dk. You can read more about Best Talent on www.besttalent.dk.