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 analyse 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.
* 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.
About us
Tubulis is a clinical stage biotech company that generates uniquely matched antibody-drug conjugates (ADCs) with superior biophysical properties that have demonstrated durable on-tumour delivery and long-lasting anti-tumor activity in preclinical models. We recently closed on a Series C fundraising round totalling €344M (US $401M).
The development of novel, effective and safe therapies for the treatment of cancer is one of the main challenges for modern medicine. We want to drive this process forward. The main goal of Tubulis is to become a leading company in the field of targeted therapeutics and ADCs. With a strong team, our own technologies and innovative therapeutic concepts, we are ushering in a new era in the ongoing fight against cancer and share the vision of helping patients world-wide. Be part of a multidisciplinary and focused team, that works towards getting novel promising ADCs to patients with solid and hematological cancers.