For our renowned client from the biotech and pharmaceutical industry we are looking for a Project Manager Process Analyst (m/f/d).
Duration: 17 months
Location: Southern Ulm area
What you can do for us
- Supervision of national and international projects and assumption of responsibility for the successful transfer of analytical methods into process control.
- Line representative Process Control, decision-making in the interdisciplinary project teams and in direct communication and coordination with external and internal customers
- Ensure analytical method readiness by processing investigations from deviations, implementing CAPAs and changes using various pharmaceutical quality system tools in a timely manner.
- Assume responsibility for the preparation of regulatory documents and liaison for regulatory enquiries and batch release of analytical results.
- Evaluation and preparation of analytical in-process data for the customer and the relevant interfaces
- Support of the Process Control department during inspections/audits
- For regulatory relevant GMP documents (sample preparation plans, process limit regulations, method validation and verification), ensure that the initiation, preparation, review and follow-up is done in a timely manner
The skills that are needed
- Completed scientific studies or advanced technical training with many years of professional experience.
- Many years of professional experience in the field of biotechnology/pharmacy with sound knowledge of analytics.
- Basic understanding of the overall value stream in biopharmaceuticals from cell banking to drug product
- Very good knowledge of the GxP environment
- Sound knowledge of regulatory requirements in biopharmaceutical manufacturing
- Very good written and spoken German and English skills
- Existing project management knowledge including basic business management knowledge
- Ability to lead interdisciplinary teams in a professional manner
- Current curriculum vitae in tabular form with job description.
- University degree/training certificate
- Certificates of further training
- If applicable, work permit, visa, Blue Card...
Why you are in the right place when working with us
- Team spirit and diversity
- Work-life balance
- Attractive remuneration
- Employee benefits
- Numerous opportunities for training
- Team and sports events
- Global network
- Attractive employee referral program
Benefits may vary based on position and location. You can find an overview of our benefits under Careers and Benefits on our website.
We are looking forward to getting to know you.
Send us your application directly. We'll be happy to answer any questions you may have. We welcome applications from people who contribute to the diversity of our company.
AKKA & Modis, now Akkodis, is a global powerhouse of technologies and digital solutions in smart industry and one of the leading providers. With over 50,000 engineers and digital experts in 30 countries, we support our customers and partners worldwide in the areas of Life Sciences, IT and digital engineering. We are looking for talented people who can work with us in driving innovation and digital transformation for a smarter and sustainable future. We put our employees first and believe that together we can make a big difference. That's why Kununu ranked us third among Germany's best employers in the consulting sector in 2021.
Phone +49 761 38908 213