Senior Director - Clinical Manufacturing

A fast-growing Biopharma CDMO is seeking an experienced Senior Director of Clinical Manufacturing to oversee all clinical-phase production activities at a specialised biologics facility in Germany. The site supports global biotech partners across Phase I–III programs, with capabilities spanning USP, DSP, aseptic filling, and viral/vector processing. This role is critical for ensuring operational excellence, GMP compliance, and successful delivery of client clinical programs.

Your Responsibilities

• Provide strategic and operational leadership for all clinical GMP manufacturing operations (USP, DSP, aseptic fill-finish).
• Oversee day-to-day production activities, ensuring batches are manufactured, documented, and released in full alignment with EU GMP, FDA, ICH, and client requirements.
• Lead a multi-disciplinary team across Manufacturing, MSAT, Scheduling, and Clinical Supply functions.
• Drive readiness for client audits, regulatory inspections, and technology transfer activities.
• Partner with Quality, Process Development, and Program Management on planning, risk management, and batch execution.
• Support scale-up, equipment selection, and introduction of new manufacturing technologies relevant to early-stage biologics.
• Develop site-level strategy for capacity, workforce, and capability expansion to meet growing clinical demand.
• Serve as senior technical manufacturing representative for internal governance and external client interactions.

Your Profile

• Degree in Biotechnology, Pharmacy, Life Sciences, Engineering, or comparable field.
• 10+ years of GMP biologics manufacturing experience, ideally within a CDMO or clinical-stage biotech environment.
• Proven leadership in managing clinical manufacturing, tech transfer, and early-phase production operations.
• Strong understanding of clinical supply chain requirements, batch disposition, and regulatory expectations for investigational products.
• Experience implementing structured processes (SOPs, batch records, deviation management, CAPAs).
• Excellent leadership, communication, and client-facing skills.
• Ability to navigate a fast-paced, evolving clinical manufacturing environment.

If this role seems interesting for you, please send your CV to sam.brown@discoverinternational.com.