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 a:

CMC Lead (f/m/d)

 What Your Day To Day Will Look Like

• Responsible for process, product and analytical development and life cycle management
• Support continuous improvement in the technology, methodology, and AOPs processes used to enhance AOPs portfolio
• Recognize opportunities for cost and risk reduction
• Responsible for information for the CMC sections of regulatory submissions (CTD) and preparation of responses from health regulatory authority related requests
• Work with cross-functional teams, both internally and with external service providers (including CMOs & CLOs)
• Owns technical relationship with CxO(s)
• Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant stakeholder(s), and propose solutions
• Provide CMC input in due diligences and portfolio expansion opportunities
• Planning budget for assigned tasks

Your Qualifications and Experience

• Higher degree in technical or scientific education, preferably chemistry, biotechnology or process engineering
• Background in CMC relevant topics, such as early and late-stage process, product, and analytical development and continuous improvement
• Preferably minimum 2 years of professional experience in a GMP environment (pharmaceutical production experience beneficial)
• Experienced in applicable EMA/FDA/ICH/WHO/ Global regulations
• Good critical thinking and analytical and problem-solving skills; back-ground in investigations, OOS, deviations and CAPAs a benefit
• Experience in regulatory submission highly desired
• Experience with health authorities a benefit
• Good verbal, presentation, and written communication skills in English and basic German skills, capable of conveying technical and project information in a concise and clear manner

Our Offer

• Open corporate culture with the opportunity to bring in your own ideas
• Great opportunities for personal and professional development
• Attractive work environment with excellent career opportunities and flat hierarchies
• Competitive salary package plus bonus and various benefits
• Structured onboarding and a buddy system
• Gross monthly salary provided for this function is a minimum of EUR 4.500.- 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!

Further information on our website: aop-health.com