The Head of mAb Fermentation & Protein Manufacturing (m/f/d) is responsible for building, leading, and operating a newly established monoclonal antibody manufacturing unit. The role covers the production of clinical and, in the future, commercial GMP batches and plays a key role in the successful start‑up, stabilization, and scale‑up of the manufacturing area.
The position combines hands‑on operational leadership with strong technical expertise and close collaboration with Development, Technical Operations, Project Management, and Quality functions.
Key Responsibilities
* Build and lead a new department for the GMP manufacturing of monoclonal antibodies at mid scale, from cleanroom installation and technical start‑up through to GMP routine production
* Actively shape the production area, including input into facility design, qualification and validation strategies, SOP landscape, and GMP organization as part of a new build or expansion project
* Take full responsibility for the manufacturing of clinical trial material and, subsequently, commercial production batches
* Lead, develop, and motivate an interdisciplinary team of up to approximately 50 employees, including operational and technical staff
* Ensure full compliance with all applicable GMP, EHS, and internal quality and safety standards
* Take responsibility for departmental budget planning and cost control
* Work in close partnership with the Project Manager, especially during technology transfer, scale‑up, and process establishment phases
* Drive operational readiness and ensure smooth transition from project phase into routine manufacturing
Manufacturing Scope
* Monoclonal antibodies and other recombinant proteins
* Single‑use manufacturing technologies
* Batch sizes typically 500 L and 2,000 L, with potential for larger volumes (up to ~5,000 L)
* Full process responsibility including fermentation (upstream) and purification (downstream)
Required Qualifications & Experience
* University degree in a natural science discipline (e.g. Biotechnology, Biochemistry, Chemistry, Pharmacy or similar); PhD or equivalent qualification is an advantage
* Several years of professional experience in the GMP manufacturing of monoclonal antibodies or other recombinant proteins
* At least 5 years of hands‑on experience in GMP‑compliant biopharmaceutical manufacturing, including participation in audits and inspections
* Proven leadership experience with direct responsibility for teams for a minimum of 3 years
* Experience in building, transferring, scaling, or expanding biopharmaceutical manufacturing areas is highly desirable
* Strong technical affinity and deep interest in manufacturing processes
* High quality mindset and strong sense of ownership
* Hands‑on, operational leadership style (not a purely strategic role)
* Strong communication skills, decisiveness, and structured working approach
* Ability to work closely and effectively with a parallel Project Management function
* Very good command of English and German
Personal Profile
* Strong team player with clear leadership presence
* Process‑driven and solution‑oriented
* Comfortable working in a dynamic, build‑up environment
* Willing to take responsibility on the shop floor and during critical project phases
SThree_Germany is acting as an Employment Agency in relation to this vacancy.