Mainz, Germany | full time | Job ID: 9851
The Director Protein & ADC Drug Product will be part of the CMC project team leading external development and manufacturing activities of protein-based therapeutics and antibody drug conjugates (ADCs). You will provide scientific and technical input to all aspects of drug product development within CMC development programs and will be responsible for review and approval of external development documentation according to regulatory expectations. Based on the CMC development strategy, the Director Protein & ADC Drug Product will also provide strategic and scientific input to the assigned development programs being responsible for establishment and execution of the drug product development strategy. In addition, you will serve as direct contact for CDMO partners related to the area of expertise.
Your main responsibilities are.
* Represent drug product expertise as DP lead and/or DP SME in assigned early and late-stage development programs
* Establish close technical collaboration with internal stakeholders and external partners
* Create, review, and approve project documentation, including development reports, risk analysis, and qualification/validation reports according to regulatory guidelines
* Support DP technical transfers between sites and filing lines as DP process owner
* Facilitate bridging and scale-up of lab DP processes to commercial GMP manufacturing by providing scientific and technical input, including troubleshooting and assessing process changes
* Support of clinical trial management and clinical operations by organization of clinical in-use studies, review of IMP questionnaires and pharmacy manuals and answering site queries
* Manage CMC timelines with respect to drug product development activities and implement risk management, including proactive mitigation plans to help ensure effective program execution
* Drive timely and data-driven decision making, and contribute to strategic discussions within CMC as well as with other internal stakeholders and external partners
What you have to offer.
* Master’s degree or preferably PhD, in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology, or a comparable field with at least 7 or more years of relevant professional experience in an international and highly regulated environment
* Proven experience in late-stage DP process development of protein-based biopharmaceuticals with sound understanding of all stages of drug development
* Experience in formulation development, lyophilization process development or in design of clinical in-use studies is considered a plus
* Sound GMP knowledge and experience with regulatory filings for biologicals (IND/IMPD, BLA/MAA)
* Leadership/management skills and assertiveness, demonstrated ability to work collaboratively within cross-functional teams, fostering a positive team environment
* Excellent communication and negotiation skills (English required, German is a plus) as well as ability to communicate complex technical matters concisely (e.g., to senior management
Your Benefits:
It's our priority to support you:
* Your flexibility: flexible hours | vacation account
* Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
* Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
* Your health and lifestyle: Company bike
* Your mobility: Job ticket | Deutschlandticket
* Your life phases: Employer-funded pension | Childcare
Apply now - We look forward to your application!
Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 12 PM to 4 PM CET).
Job ID 9851 (please always specify if you have any questions)
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