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Senior scientist - cell line & usp development

München
Tubulis GmbH
Scientist
Inserat online seit: 11 März
Beschreibung

The Position within Tubulis’ Chemistry Manufacturing & Control team is responsible for the external development of high-performing production cell lines as well as developing robust and efficient cell culture processes. Additionally, this role supports GMP technology transfer of upstream processes to GMP manufacturing in our Contract Manufacturing network.


Your mission


* Oversee the generation and characterization of stable production cell lines for recombinant antibody modalities
* Manage the cell banking of Research, Master, and Working Cell banks across Tubulis’ portfolio
* Act as the subject matter expert during the design, development and optimization of scalable upstream processes
* Support scale-up and technology transfer activities to pilot and GMP manufacturing sites
* Author and review development reports, risk assessments, batch records and relevant CMC sections for regulatory dossiers, etc.
* Close collaboration with Quality Assurance, Regulatory Affairs and external partners


Your profile


Must-Have Qualifications:

* A university degree in biotechnology, biochemistry, or related subjects (B.Sc. or M.Sc.)
* Min. 5 years combined working experience (M.Sc.)/min 8 years combined working experience (B.Sc.) in cell line development and Upstream Processing of recombinant proteins
* Strong expertise with CHO cell lines, transfection, single cell cloning, and high throughput clone screening technologies.
* Strong understanding of global CMC regulatory requirements, including ICH guidelines and expectations from EMA, FDA, and/or other health authorities.
* Know-how in GxP to efficiently communicate between development, quality, and regulatory functions
* Good proficiency in spoken and written English is a must
* Experience in downstream processing of therapeutic proteins is a plus


Nice-to-Have Qualifications:

* Downstream Development & Manufacturing


Why us?


At Tubulis, curiosity and innovation drive us to transform cancer treatment. We are a fast-growing biotech where science meets passion—and where you have the chance to grow with us.


* Impact that matters: Contribute to breakthrough therapies.
* Global mindset: Work in an international, diverse team.
* Grow & thrive: Develop your career in a supportive, fast-moving environment.
* Innovation every day: Push boundaries with cutting-edge science.


At Tubulis, your ideas matter, your growth matters—and together, we make a difference.

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Home > Stellenangebote > Wissenschaft Jobs > Scientist Jobs > Scientist Jobs in München > Senior Scientist - Cell Line & USP Development

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