Biotechnology Research

Ethris GmbH

51-200

Germany

## 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 problem-solving skills
* High quality consciousness, solution-oriented 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

Employee

Professional / Experienced

<h2 id="our-mission">Our mission</h2>
<p>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&#39;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.</p>
<h2 id="our-offer">Our offer</h2>
<p>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.  </p>
<p>Join our team as <strong>Director</strong> <strong>CMC</strong> <strong>(m/f/d),</strong> advance your career, and become part of an amazing journey to bring new and breakthrough genetic medicine to patients worldwide.  </p>
<h2 id="your-tasks">Your tasks</h2>
<ul>
<li>Manage and oversee manufacture of excipients, drug substance and IMP at Ethris CDMO network</li>
<li>Manage and oversee stability studies of excipients, drug substance and IMP</li>
<li>Supervise and control QC testing as well as characterization of excipients, drug substance and IMP</li>
<li>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</li>
<li>Be part of the interdisciplinary team developing the quality strategy for Ethris products from early Phases to market supply</li>
<li>Generation and/or review of regulatory documents</li>
<li>Provide project teams with information on production requirements as well as manufacturing budget and timelines</li>
<li>Lead a team of employees responsible for Ethris CMC activities</li>
</ul>
<h2 id="your-profile">Your profile</h2>
<ul>
<li>Demonstrated knowledge and expertise in regulatory CMC preferably on ATMPs and/or nucleic acid products</li>
<li>Several years of industrial experience in relevant area</li>
<li>Educational background in chemistry, biochemistry, pharmaceutics, or closely related discipline</li>
<li>Excellent knowledge of international GMP/GDP regulations</li>
<li>Leadership and problem-solving skills</li>
<li>High quality consciousness, solution-oriented mindset and strong communication skills</li>
<li>Very good written and verbal communication skills in English and German</li>
<li>Experience with managing CMOs or external suppliers is beneficial</li>
<li>Project management skills is a plus</li>
</ul>


Director CMC (m/w/d)

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