Are you looking for a change of pace? Then hit the ground running with Dynavax!
Over the past 30 years, Dynavax has proven its innovative potential in developing and manufacturing biopharmaceuticals. Our production processes follow the highest quality standards. This is true for all our products, including our new Hepatitis B vaccine Heplisav™ (currently undergoing clinical trials in the US). We are seeking a Process Specialist to maintain these quality standards before and during production.
Your scope of duties:
As an experienced specialist in the manufacturing of pharmaceuticals, you are responsible for the timely processing of quality documents. You keep a constant watchful eye on deviations, change control, CAPAs and OOS during production of our hepatitis B drug substance. Utmost efficiency is ensured by your close cooperation with other departments (QA, Engineering, QC, Tech Ops Support).
Thanks to your work, process errors are a thing of the past as you meticulously inspect failure investigation re ports and respond to them accordingly. You proactively provide your knowledge by defining corrective / preventive actions – supervising their timely implementation and statistically tracking all relevant measures. Furthermore, you execute and track change control requests while actively participating in change control meetings as an expert on the subject.
Your extensive cooperation with Manufacturing Operators helps to constantly optimize the manufacturing process. You develop optimization measures in personal discussions and supervise their implementation. Your technical reports and root cause investigations represent yet another important pillar for error-free production.
You have a university degree in Life Sciences (Biotechnology, Engineering, Biology, Chemistry, etc.) or similar qualifications
You have in-depth work experience of at least 3 years in the manufacturing of pharmaceuticals, ideally biopharmaceuticals / aseptic manufacturing
You are proficient in the use of root cause investigational tools and performing data analyses
You have profound experience in deviation and change management
You have extensive knowledge of manufacturing plants and clean rooms as well as knowledge of standard regulations (EU GMP guidelines, CFR, AMWVH, etc.) and comprehensive GMP skills
You have strong communication skills and the ability to train others on complex processes
You are an excellent problem solver with strong analytical thinking and documentation skills
You can communicate both in English (excellent writing skills!) and German
Are you ready to work in a challenging, but also dynamic and growing environment?
Then submit your application and make a difference in a position that gives you room to grow. We offer a competitive compensation package including benefits, a flat hierarchy and many opportunities for professional development. We look forward to hearing from you.