About this role
About Us
ten23 health is a human-centric and sustainable strategic partner of choice for the pharmaceutical industry and biotech start-ups for the development, manufacture, and testing of tomorrow’s medicines. We support our clients in developing differentiated, stable, usable, and safe injectable treatments for patients.Your mission
80-100% FTE I VispWe are looking for a MSAT Expert to contribute to the development and production of cutting-edge injectable therapies. As a key member of our team, you will play a pivotal role in ensuring the successful transfer, optimization, and validation of drug product processes.
Your responsibilities will include,
- Technical/strategic leadership in successful implementation, transfer, supervision, and optimization of DP (drug product) processes (sterile manufacturing) in close collaboration with customer project teams
- Support product & process qualification and validation incompliance with GMP and customer requirements
- Development and implementation of standardized MSAT procedures/processes
- Support technical challenges and complex root cause investigations incl. data analysis for process-related investigations/deviations, product impact assessments, change control assessments, CAPA assessments, raw material qualification, etc
- Technology assessments and scale up in in engineering and green field projects
- Drive process improvement initiatives and continuous improvements
Your profile
We are looking for someone with:- A Master's degree or higher in a Life Science discipline, such as biology, biochemistry, or biotechnology. A strong academic foundation in these areas is essential for understanding complex biological processes and their application in manufacturing.
- A minimum of 4 years of hands-on experience in a similar role. Practical experience in sterile manufacturing, process transfer, and optimization is crucial for success in this position.
- A passion for innovation and a proven ability to drive process improvements. We are looking for individuals who are eager to contribute to the advancement of our manufacturing processes.
- Fluency in English is required for effective communication and collaboration with our international team and clients. German is a plus.
Why us?
We offer a dynamic environment where you can contribute meaningfully, collaborate with exceptional minds, and unlock your full potential.Here's what sets ten23 apart:
- A valuable and impactful career development opportunity in an inspiring environment
- Flexible working arrangements and environment with an open culture and diverse workforce
- The opportunity to work with and learn from highly qualified and experienced employees
- Our learning and self-developing culture offers a wide range of training options
- Competitive pension fund plan, annual bonus, and other financial and non-financial benefit
Contact
For more information and clarification, please connect with Amrith from our Talent team!About us
While most applicants fall short of 100% qualifications, we embrace diverse perspectives and encourage applications from all qualified candidates, regardless of background. Women & underrepresented groups, we see you!Join Us & Make a Difference! ten23 champions equal opportunity and is committed to diversity and inclusion.
Learn about ten23, https://www.youtube.com/watch?v=HgS3wd03JV0
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Read the MSAT Expert e/v/e/r/y/o/n/e listing at ten23 health (https://www.getclera.com/jobs/ten23health/msat-expert-e-v-e-r-y-o-n-e-mq70wgcjk5yy) and tell me whether it fits my profile. Save it for me if it does.
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