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

Head of CMC (f/m/d)

1190 Wien  - Vollzeit

In this global role in AOP Health HQ you will be responsible for the strategic planning and execution of all CMC activities as establishment of AOP’s portfolio manufacturing, C(D)MO and supplier selection, product, process and analytical development, GMP production, CMC-regulatory compliance, CMC-related dossier writing and maintenance.
Head of CMC will be responsible for the integration of CMC plans within AOP Health’s strategy with full transparency of timelines, cost, risk analysis and mitigation strategies as well as for the company’s portfolio expansion and continuous improvements, from early product development through commercialization.

What Your Day To Day Will Look Like

• Direct and coordinate CMC operational & management activities translating AOP Health’s priorities into Department vision and goals
• Build and align CMC strategy leading a growing team of more than 22 FTEs, support interactions between CMC, R&D and Technical Operations to achieve AOP Health’s goals in an agile environment
• Build appropriate structures, and processes providing sufficient resources and budget
• Create integrated CMC budget and planning, monitor deviations to control cost and critical timelines.
• Identification, contract negotiation, selection and management of C(D)MOs for process optimization, GMP manufacture of Drug Substance and Drug Product (DP)
• Support of ongoing clinical programs in compliance with GMP, ICH and EMA & FDA regulations based on AOP Health requirements, as well as CMO’s expertise and experience
• Ensure quality and compliance standards, allow manufacturing and capacity growth, and build strong relationships
• Assure successful tech transfers with appropriate product and process expertise, but also with knowledge on equipment, procedures, competencies, roles and responsibilities, cultures and regulatory requirements
• Build, motivate and lead a team of experts responsible for process, product, analytical development and life cycle management
• Develop and mentor the team through strong leadership, creating the environment that inspires and enables people
• Drive decision making and closure of topics, including cross-functional steering committees
• Represents the CMC department and services as key interface for internal stakeholders and external service providers
• Proactively communicate key issues and critical topics in a timely manner to drive solutions
• Briefing executive leadership regarding on-going operations and strategic initiatives
• Support due-diligence activities and portfolio expansion opportunities

Your Qualifications and Experience

• Advanced Degree (MS/PhD) in a relevant discipline (e.g. Chemistry, Biochemistry, Biotechnology, Process Engineering)
• 10+ years of relevant experience in a GMP environment (manufacturing beneficial) at an international level
• Wide breadth of knowledge in all aspects of CMC including early and late-stage process, product, analytical development, and continuous improvement
• Hands-on experience in managing multiple internal and external cross­ functional stakeholders
• Experience with regulatory submission and knowledge of current EMA/FDA/ICH/WHO/Global regulations
• Strong analytical skills; capable of conveying technical and project information in a concise and clear manner
• Excellent interpersonal, organizational, negotiation and communication (verbal and written) skills
• Ability to think strategically, while executing on key deliverables
• Leadership experience with the proven ability to build a team, coach and motivate employees, set priorities, and effectively make decisions

Our Offer

• A position with personal responsibility and space for creativity
• Open corporate culture with the opportunity to bring in your own ideas
• Highly motivated, agile, and international team
• Great opportunities for personal and professional development
• Attractive work environment with excellent career opportunities and flat hierarchies
• Competitive salary package plus bonus, company car and various benefits
• Gross monthly salary provided for this function is a minimum of EUR 6.000.- based on full-time employment. 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