(Senior) Director CMC Project Management // (Senior) CMC Expert (m/f/d)
Job Description:
Location: Heidelberg, Germany (Hybrid)
Start Date: Immediate
Responsibilities
* Establish and implement CMC processes at VERAXA Biotech GmbH.
* Take full responsibility for all early-stage CMC activities across our pipeline programs.
* Identify program requirements and translate them into actionable work packages and project plans.
* Oversee CMC activities at Contract (Development) and Manufacturing Organizations (C(D)MOs) – including planning, coordination, execution, and monitoring – ensuring alignment with scope, budget, timelines, and quality standards.
* Collaborate closely with Program Leaders as well as Heads of Chemistry and Production.
* Represent the CMC function in cross-functional ADC and TCE project teams and ensure alignment of CMC strategy with overall project plans.
* Communicate complex topics clearly and effectively, both internally and externally.
* Establish efficient information and communication flows, including regular status updates, risk management, and project reviews.
* Drive successful achievement of program goals.
* Ensure project objectives align with VERAXA’s overall strategic vision.
Requirements
* PhD in Chemistry, Biotechnology, Biology, Engineering, Life Sciences or a related discipline.
* At least 5 years of hands-on experience in managing CMC projects at C(D)MOs.
* Solid knowledge of CMC processes for TCEs and ADCs; ideally with experience in regulated environments (e.g. GMP, GCP, GCLP), up to IND submission.
* Strong interpersonal and influencing skills, including the ability to lead without formal authority and motivate cross-functional teams – preferably within matrix organizations.
* Proven ability to troubleshoot and resolve technical challenges efficiently.
* Commitment to promoting a strong quality culture across all teams.
* Excellent verbal and written communication, presentation, and project management skills.
* Fluency in English (written and spoken) is essential. German skills are a plus.
Working at VERAXA
Working at VERAXA Biotech offers the chance to be part of a passionate team dedicated to making a positive impact. We focus on innovation and quality, developing cutting-edge biotherapeutics to improve patient outcomes. We seek ambitious and talented individuals to join us in transforming targeted therapies. Our culture emphasizes flat hierarchies and efficient processes, prioritizing scientific excellence.
At VERAXA, we are building a leading platform for discovering and developing next-generation antibody-based therapeutics, including bispecific ADCs, bispecific T cell engagers, and other innovative formats. Using advanced technologies and quality-by-design principles, we are advancing our pipeline into clinical development. Founded on scientific breakthroughs from the European Molecular Biology Laboratory, we are committed to pioneering life science research and technology.
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