- Facilitate the CMC project-planning process, drive execution of CMC development plans and CDMO manufacturing and monitor progress
- Coordinate and monitor product development (cell line, USP, DSP, formulation and analytical development) for compounds from Affimed’s proprietary ROCK® platform through the entire development cycle from enabling IND, clinical supply up to regulatory filing
- Plan, coordinate and manage phase-appropriate cGMP-compliant manufacturing activities at CDMOs starting from IND-enabling production to late stage clinical supply and validation
- Manage the identification and selection of adequate service providers for development and manufacturing activities
- Drive identification, evaluation and implementation of new technologies for process development, formulation and protein analysis
- Lead the preparation of CMC project budgets, facilitate appropriate review, and maintain forecasts
- Regularly interact with functional areas beyond CMC, such as Research, Non-Clinical Development, Regulatory, Quality, Supply Chain and Clinical; member of a cross-functional project team
- Ensuring delivery of high quality data, presentations and reports including required documentation for regulatory filings (IND/BLAs)
- University degree and a minimum of 12 years related experience or Ph.D. with a minimum of 6 years relevant experience. BLA experience is highly desired, broad pharmaceutical lifecycle management experience preferred.
- Strong technical expertise in analysis, development and manufacturing of biologicals including technology transfers; experience with products in clinical development phase preferred
- Strong team collaboration skills as well as ability to work independently; ability to lead through example and to establish an environment fostering effective and collaborative working relationships in multi-disciplinary teams
- Excellent organizational skills and the ability to manage concurrent deliverables and work effectively towards solutions in a challenging, milestone-driven environment
- Proficient in managing budget, timeline and alignment
- Excellent oral communication skills as well as sound technical writing and documentation competencies in English; strong oral, written and listening skills
The successful candidate will have the unique opportunity to work in a dynamic, highly motivated, multidisciplinary and collegial team. She/he will be involved in front-line and challenging research and development projects on novel technologies in the therapeutic antibody field that enables the development and characterization of our product candidates.
For any queries please contact Susanne Hering (Tel: +49 (0)6221 6743-675, e-mail: firstname.lastname@example.org).