Director Cmc - Planegg, Deutschland - Ethris GmbH

Ethris GmbH

Geprüftes Unternehmen

Planegg, Deutschland

vor 2 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

Our mission:

At Ethris, we are working at the forefront of medical innovation and technology. To us, this is a once-in-a-lifetime chance, working on rethinking human therapeutics. We strive towards developing the next generation of mRNA therapeutics and vaccines for respiratory diseases.

We're a dedicated and skilled team of around 70 with different cultural backgrounds, all following the goal of revolutionizing medicine and bringing ground-breaking new therapies to patients worldwide.

With our truly innovative, self-developed and IP-protected suite of platforms for lipidoid nanoparticle delivery, mRNA design and optimization, mRNA manufacturing and drug product stabilization at room-temperature, we are uniquely positioned to achieve our ambitious goals.

Our offer:

As a highly ambitious and thriving biotech company, we offer you an extremely interesting but also demanding job. You will have the opportunity to quickly expand your operational, strategic, and personal skills in a highly motivated team. An open communication culture and working atmosphere combined with a strong team spirit contribute to our success.

Join our team as
Director
CMC (M/F/d),** advance your career, and become part of an amazing journey to bring new and breakthrough genetic medicine to patients worldwide.

Your tasks:

Manage and oversee manufacture of excipients, drug substance and IMP at Ethris CDMO network
Manage and oversee stability studies of excipients, drug substance and IMP
Supervise and control QC testing as well as characterization of excipients, drug substance and IMP
Participate in quality management system procedures, such as OOS/deviation management, change control, supplier qualification, CAPAs/root cause investigation, quality risk management, product specification file
Be part of the interdisciplinary team developing the quality strategy for Ethris products from early Phases to market supply
Generation and/or review of regulatory documents
Provide project teams with information on production requirements as well as manufacturing budget and timelines
Lead a team of employees responsible for Ethris CMC activities

Your profile:

Demonstrated knowledge and expertise in regulatory CMC preferably on ATMPs and/or nucleic acid products
Several years of industrial experience in relevant area
Educational background in chemistry, biochemistry, pharmaceutics, or closely related discipline
Excellent knowledge of international GMP/GDP regulations
Leadership and problemsolving skills
High quality consciousness, solutionoriented mindset and strong communication skills
Very good written and verbal communication skills in English and German
Experience with managing CMOs or external suppliers is beneficial
Project management skills is a plus

About us:

Ethris is located in Munich, a very beautiful, exciting and safe city in southern Germany that offers a particularly high quality of life.

The Munich region is considered one of the leading biotech hubs in Europe.

Ethris truly benefits from the strong scientific cluster-knowledge in the region, driven by intense scientific exchange and collaboration with Munich's renowned academic institutions, such as Ludwig Maximilian University, Technical University, Max Planck Institutes of Biochemistry and Neurobiology, and the Helmholtz-Center - as well as with other life science companies.