Be part of our team
The CMC laboratory team leads and supports the development and optimization of analytical methods for our lead projects, while providing a high-standard platform for the analysis and characterization of a variety of different internal projects. Together with the whole CMC department, we plan and analyze experiments, which support and facilitate the transition from R&D/pre-clinical projects to the CMC stage, and help to develop our technology further.
Your mission
Management:
- Support the whole life cycle of existing and new linker-payloads, managing the early phase to late-stage development campaigns at CMOs, up to commercial processes.
- Build strong relationships with CMO teams, providing clear technical direction and expectations.
- Monitor progress, identify risks, troubleshoot issues and implement corrective actions as needed, to ensure timely delivery of milestones.
- Support the authoring of IND, IMPD and other regulatory filings.
- Effectively communicate project status and results to internal stakeholders.
- Define project timelines, budgets, and deliverables for CMO engagements.
Process Development:
- Design and refine synthetic routes for small molecule products in collaboration with the CMOs SMEs, reducing the cost and improving production cycles.
- Proficient in analytical techniques like HPLC, NMR, GC, IR, and MS for product characterisation.
- Strong experience of purification techniques (precipitations/crystallisations, column chromatography, distillations). Knowledge of freeze drying and/or SPS is a plus.
- Translate lab-scale processes into scalable, robust, and cost-effective procedures for CMO implementation.
- Analyse and interpret analytical data to ensure product quality and process efficiency.
GMP Manufacturing and Manufacturing Network development:
- Support GMP production at CMOs by reviewing/approving batch records and taking ownership of change controls and deviations.
- Manage technology transfers between CMOs as applicable to align with business needs.
- Contribute to building a network of suppliers to diversify Tubulis’ supply chain.
- Identify and qualify suitable CMO partners based on capabilities, capacity, and cost considerations, as applicable based on the company strategy.
Your profile
Qualifications:
- MSc/PhD degree in Organic Chemistry, Synthetic Chemistry, Pharma Chemistry, Pharmaceuticals, Medicinal Chemistry or related field. Minimum of 7 years of experience in API process development and scale-up required with a MS degree. Minimum of 4 years of experience in API process development and scale-up required with a PhD.
- Extensive industrial experience in chemical process development for small molecules.
- Experience scaling-up processes from lab to pilot scale.
- Excellent knowledge of CMC and cGMP activities.
- Deep understanding of global regulatory requirements (ICH guidelines, EU/US regulations).
- Experience in reviewing MBR, EBR and reports.
- Experience with analytical method development is a strong advantage.
- Experience with late-stage process qualification and validation is a must.
- Experience with MODDE or other DoE software is a strong advantage
- English fluency is a must
- German knowledge is an advantage
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.
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Impact that matters: Contribute to breakthrough therapies.
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Global mindset: Work in an international, diverse team.
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Grow & thrive: Develop your career in a supportive, fast-moving environment.
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Innovation every day: Push boundaries with cutting-edge science.
At Tubulis, your ideas matter, your growth matters—and together, we make a difference.
