External Manufacturing Lead (f/m/d)

AOP Health is the European pioneer for integrated therapies for rare diseases and in critical care. To enhance our team in Vienna we are looking for an:

In this key role you will be responsible for the day-to-day operational and project management of external manufacturing, development, and testing activities across AOP Health´s network.
This is a key expert role that bridges internal teams and external partners - ensuring our products move seamlessly from development to manufacturing and beyond.

• Lead and coordinate operational and project activities with assigned external manufacturing, development, and testing partners to support product development, clinical manufacturing, and PPQ execution
• Act as the main point of contact for selected partners and assigned programs — managing relationships, performance, budget and goal alignment
• Oversee clinical supply planning, including material readiness, shipments, and inventory coordination
• Responsible for production/testing scheduling and partner performance monitoring
• Manage budgets and identify opportunities for cost and risk reduction
• Contribute to Technical Development’s (TD) external partnerships strategy to strengthen AOP Health’s global manufacturing and testing network
• Provide technical and operational input during contract negotiations
• Identify and mitigate risks with internal stakeholders
• Represent External Manufacturing function within TD matrix and Supplier Relationship Management (SRM) teams
• Lead or support cross-functional Virtual Plant Teams (VPTs), driving quality, cost, and delivery excellence
• Facilitate effective communication and decision-making across teams
• Support regulatory response preparation (e.g., inquiries, LODs) related to outsourced activities
• Ensure compliance with internal processes and global health authority requirements
• Contribute to due diligences, portfolio expansions, and business case development
• Drive continuous improvement and harmonization initiatives within TD

• Advanced degree (PhD or Master’s) in a technical or scientific discipline, preferably in chemistry, biotechnology,
  or process engineering.
• Solid expertise in at least one CMC area (e.g., process development, analytical development, technical writing, or manufacturing) with broad understanding across the CMC domain.
• Minimum 5 years of professional experience in a CMC environment (e.g., GMP manufacturing).
• Familiarity with EMA/FDA/ICH/WHO/global regulatory frameworks.
• Experience with investigations, OOSs, deviations, and CAPAs is a plus.
• Proven ability to work effectively in cross-functional matrix teams and represent TD’s perspective.
• Strong ownership mindset with proactive drive to move workstreams forward.
• Strategic thinker who can translate the big picture into clear operational goals.
• Collaborative, customer-oriented approach with strong stakeholder management skills
• Excellent contract negotiation skills and experience collaborating with external partners
• Proven ability to drive Operational Excellence initiatives (Lean / Six Sigma Green Belt or equivalent preferred)
• Excellent communication, presentation, and writing skills in English; basic German is an advantage.
• Strong analytical and problem-solving skills.
• Experience with end-to-end budget planning and management.
• Hands-on ERP system experience and solid project management skills (PMP certification or similar is an asset).
• Willingness to travel internationally as needed

• An open corporate culture with the opportunity to contribute your own ideas
• Working independently in a collegial and committed team
• Modern working environment with good public transport connections (U4 - Heiligenstadt)
• Flexible working hours (flexitime/time-out days), bonus scheme, additional benefits and employee events
• Structured onboarding and support through a buddy system
• Gross annual salary provided for this function is a minimum of EUR 80.000.- based on full-time employment (38,5h/week). Any potential overpayment depends on professional experience and qualifications.