Join a global, research-driven biopharmaceutical organization that is rapidly expanding its footprint in complex biologics and next-generation oncology solutions. You will be part of a company that combines the stability of a innovative pharma player with the agility of an innovation-focused biotech environment.
Here, experienced professionals are trusted to take ownership, challenge the status quo, and shape manufacturing standards in highly regulated settings. If you enjoy building robust GMP operations from the ground up and want your work to translate directly into better outcomes for patients, this is the right environment for you.
As Scientist GMP Manufacturing - ADC, you will play a pivotal role in establishing a new GMP drug substance production unit for Antibody-Drug Conjugates (ADCs) .
In the initial phase, you will act as a GMP subject matter expert during the design and build-up of a state-of-the-art bioconjugation facility - contributing to layout, processes, documentation, and regulatory compliance.
Once the suites are operational, your focus will shift to ensuring robust, compliant, and efficient routine manufacturing operations in a highly regulated biopharmaceutical environment.
This role is ideal for experienced GMP professionals who enjoy combining technical depth in bioconjugation with the structuring and standardization needed to run a high-performing, inspection-ready facility.
Your Key Responsibilities
* Contribute to the concept, planning, and implementation of a new GMP production area for biotechnological active substances, with a primary focus on Antibody-Drug Conjugates (ADCs) .
* Translate GMP requirements into practical processes, workflows, and equipment concepts, ensuring efficient and compliant material and personnel flow.
* Develop, author, and maintain GMP documentation, including manufacturing instructions, SOPs, batch records, and related operational documents.
* Support the design and construction of GMP production suites, including cleanroom zoning concepts, segregation strategies, and material/personnel flows, aligned with the global construction and engineering project.
* Oversee and support equipment qualification, lifecycle management, and use, ensuring that all critical systems are operated in full compliance with GMP and regulatory expectations.
* Collaborate closely with Antibody Production, Quality Management, and R&D to ensure seamless tech transfer and smooth integration of new processes into manufacturing.
* Contribute to a culture of quality and continuous improvement, using deviations, CAPAs, and new technologies as levers to optimize manufacturing processes.
What You Bring
Education & Experience
* Master's degree (or equivalent) in Biochemistry, Chemistry, Chemical Engineering, Biotechnology, or a closely related discipline.
* Significant professional experience in bioconjugation or biopharmaceutical manufacturing (e.g., ADCs, protein/peptide conjugates, biologics).
* A strong track record of working in a GMP-regulated environment (ideally commercial or late-stage clinical manufacturing).
Technical Expertise
* In-depth understanding of bioconjugation chemistries and techniques (e.g., antibody-drug conjugates, peptide or protein conjugates).
* Solid knowledge of purification and characterization of bioconjugates and biopharmaceutical compounds, as well as relevant analytical methods .
* Thorough and practical understanding of GMP regulations and guidelines, and how to implement them into day-to-day operations.
* Demonstrated experience in the creation, review, and maintenance of GMP documents (SOPs, work instructions, batch records, etc.).
Additional Skills & Attributes
* Proven ability to work effectively in cross-functional, international teams, collaborating with Quality, Regulatory, Production, and R&D.
* Strong quality mindset with the ability to embed GMP thinking into processes and team behavior.
* Hands-on approach to troubleshooting technical issues and supporting investigations.
* Experience with CAPA-driven optimization and openness to implementing new manufacturing technologies .
* Independent, structured, and goal-oriented working style paired with a high level of ownership and commitment.
* Very good German and English language skills, both spoken and written.
Why Join This Role?
* Build something new: Be directly involved in the setup of a new GMP ADC manufacturing unit - from design to steady-state operation.
* High impact, highly visible: Your work will have a tangible impact on future oncology therapies and will be highly visible across the organization.
* Modern, flexible working environment: Benefit from a hybrid working model and a culture that truly supports work-life integration.
* Personal and professional growth: Access to structured development opportunities, continuous learning, and a broad, global network of experts across manufacturing, quality, and development.
* Wellbeing and support: Attractive benefits package including health and wellbeing initiatives, competitive compensation, and support programs designed to help you thrive both professionally and personally.
* Inclusive, respectful culture: Join a team where diversity, mutual respect, and open dialogue are not slogans but everyday practice. Your ideas and proactive mindset are genuinely valued.
If you are excited by the idea of shaping a new GMP ADC manufacturing capability, enjoy working at the interface of science, operations, and regulation, and are looking for a role with real impact on patients' lives, we would be delighted to hear from you.
👉 Please submit your CV (and, if available, a brief summary of your experience in GMP bioconjugation/manufacturing) via the application channel provided in this posting.
SThree_Germany is acting as an Employment Agency in relation to this vacancy.