Production Manager - ATMP

Production Manager – AAV Manufacturing (Gene Therapy)

Location

Germany (on-site / Frankfurt)

Company

Confidential CDMO – Advanced Therapies / Gene Therapy

Role Overview

The Production Manager will lead GMP AAV manufacturing operations within a CDMO environment, overseeing upstream, downstream, and fill/finish activities as applicable. The role focuses on safe, compliant, and scalable production of clinical and commercial AAV drug substance and/or drug product while supporting tech transfer, process optimisation, and client programs.

This is a hands-on leadership role requiring strong people management, operational discipline, and experience working with external pharma/biotech clients .

Key Responsibilities

Manufacturing & Operations

• Lead day-to-day GMP production of AAV vectors across USP, DSP, and associated support operations
• Ensure manufacturing activities meet GMP, EHS, and quality standards
• Plan and execute production campaigns for clinical and commercial programs
• Own shift planning, capacity planning, and resource allocation
• Drive right-first-time execution and continuous improvement initiatives
• Manage, coach, and develop a team of Manufacturing Supervisors, Scientists, and Technicians
• Build a strong GMP culture focused on compliance, safety, and accountability
• Support recruitment, onboarding, and training of manufacturing staff
• Support process transfer from development into GMP manufacturing
• Collaborate with MSAT, Process Development, and Quality teams on scale-up and troubleshooting
• Contribute to process robustness, yield improvement, and cost efficiency

Quality & Compliance

• Ensure compliance with EU GMP, FDA, and local regulatory requirements
• Lead and support deviation investigations, CAPAs, and change controls
• Participate in audits and regulatory inspections
• Ensure accurate and timely batch documentation review

Client & Cross-Functional Interaction

• Act as an operational point of contact for CDMO client programs
• Support client meetings, manufacturing readiness, and issue resolution
• Work closely with QA, QC, MSAT, Engineering, and Supply Chain

Required Experience & Qualifications

• Degree in Biotechnology, Biochemical Engineering, Biology, or related discipline
• 5–10+ years experience in GMP biologics or gene therapy manufacturing
• Proven experience with AAV production (or closely related viral vectors)
• Strong understanding of USP/DSP operations and aseptic processing
• Previous experience in a CDMO or multi-client environment strongly preferred
• Demonstrated people-management experience in GMP operations

Technical Knowledge (Preferred)

• AAV production platforms (adherent or suspension)
• Transfection, harvest, clarification, chromatography, and TFF
• Single-use bioprocessing technologies
• Aseptic manufacturing and contamination control strategies
• GMP documentation systems and electronic batch records
• Clear and confident communicator in a client-facing environment
• Strong ownership mindset and continuous-improvement mentality
• Fluent German and English (or strong working proficiency)

Why This Role

• Join a growing gene therapy CDMO with long-term investment in AAV
• Exposure to multiple client programs from early clinical to commercial
• Opportunity to shape teams, processes, and future capacity