Technology Transfer Specialist – Biotech Manufacturing

Technology Transfer Specialist – Biotech Manufacturing (m/w/d)

For our client, a leading biopharmaceutical company specializing in cutting‑edge biologics drug substance manufacturing for early‑phase clinical supply, we are seeking a Technology Transfer Specialist (m/w/d). The state‑of‑the‑art biotech facility operates with a flexible, multi‑product strategy that integrates the latest technologies into the clinical pipeline to enable rapid, agile product launches and drive innovation in biologics‑based medicine development.

• Drive the introduction of new biological products into manufacturing by coordinating schedules and ensuring tasks are completed on time and right‑first‑time.
• Prepare and manage GMP‑compliant documentation such as risk assessments, change controls, batch records, sampling plans, and Bills of Material (BOMs).
• Maintain and update data across digital manufacturing systems including SAP COMET, MES, and Delta
  
  V.
• Develop and support process descriptions, facility fit analyses, and process models for continuous and fed‑batch manufacturing processes.
• Contribute to the design and rollout of best practices in tech transfer, focusing on streamlining and reducing risk toward fully digitized workflows.
• Author, review, and maintain SOPs, Work Instructions, Electronic Batch Records (EBRs/gBMRs), and related manufacturing documents.
• Apply strong analytical and problem‑solving skills to support cross‑functional and global teams in resolving technical challenges.

• Degree in a scientific or technical discipline (e.g., Biology, Chemistry, Biotechnology, Engineering, or related field).
• Minimum 5 years of professional experience in the pharmaceutical or biotech industry, ideally in a GMP‑regulated biologics drug substance manufacturing environment.
• Hands‑on experience with digital and automation systems such as DeltaV, MES, eVal, and SAP COMET.
• Solid understanding of cGMP regulations and the principles of New Product Introduction / Technology Transfer.
• Familiarity with mAb unit operations and experience with single‑use manufacturing systems is a plus.
• Proven ability to manage small projects within cross‑functional teams, including basic project management skills.
• Fluent in English (written and spoken, minimum B1);
  German language skills are an advantage.
• Collaborative team player with a proactive mindset and a genuine drive for continuous improvement and learning.