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.
What your day to day will look like:
* 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
* Drive continuous improvement and harmonization initiatives within TD
Your Qualifications and Experience:
* 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
Our Offer
* 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.
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