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External Manufacturing Lead (f/m/d)

Full-time Vienna

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
  • Contribute to due diligences, portfolio expansions, and business case development
  • 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.
If you would like to work as a team player in an international environment and can identify with our values "Agile, Ambitious, Aligned, Accountable and Appreciative", then: Take this CHANCE and
APPLY NOW

Please submit your application exclusively via the application link.

Introduction

Main Benefits

Bonus
Homeoffice
Flexible working hours
Initial and continuing education
Canteen
Good transport connection
Employee events
Meal allowance
Company doctor
Parking spot
Healthmeasures

Your Contact


Angelika Drabek
Manager Talent Acquisition

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