For Gene Therapy Process Development team we are seeking a CMC Lead. The CMC Lead sets product development strategy to enable execution of Chemistry, Manufacturing, and Controls (CMC) activities. The CMC Lead manages project teams and is responsible for providing technical leadership to cross-functional teams.
About the position:
- Develop and execute Technical Operations strategy for specific product, including process and assay development, characterization, validation, technical transfer, CMC filing documents, and support product stability
- Ensure technical rigor of team deliverables and provides broad drug development oversight to the team
- Responsible for communication of product strategy and interests to diverse stakeholders, seek input from relevant functions, and ensure that Technical Operations perspectives (interests and constrains) are fully considered in the overall product strategy and execution plan
- Ensure appropriate endorsement of team recommendations and work streams
- Develop budget, resources requirements, and schedule to deliver product strategy and plans
- Responsibility for CMC Stage Gate Deliverables
- Drive rigorous assessment of issues and options
- Drive consensus and timely decision making
- Open communication and collaboration with internal and external partners (i.e. Process and Formulation Development, Process Analytics, Analytical Development, Manufacturing, Research, QA, QC, Engineering, Supply chain, Validation, Tech transfer, Regulatory and authorities)
Skills you will need:
- Minimum 5 years of biotechnology/pharmaceutical industry experience in the Chemistry, Manufacturing & Controls (CMC) environment
- Relevant experience with Gene Therapy or Viral Vectors ideally in product development, research or manufacturing
- Master?s degree in the life sciences, chemical or industrial engineering or equivalent required; a PhD degree in a relevant area is an advantage
- Strong communication skills to effectively facilitate cross-functional teams in a matrix environment
- Strong leadership skills (persuasive, encouraging and motivating)
As a leading global biotechnology company we have one mission every day: to lastingly improve the lives of people living with rare diseases. Crucial to our mission are our employees - our biggest asset - who enjoy a range of benefits and career opportunities, such as trainee and training programs, job rotations, apprenticeships, work-life balance (certified family friendly), company kindergarten, wellness center, cafeteria, etc. Here you can learn more about Shire in Austria.
We offer outstanding opportunities to motivated people regardless of your gender, age, skin color, ethnicity, sexual orientation or physical handicaps. Diversity is part of our success!
The minimum salary for this position is € 4.500,- gross per month (full-time); increased payment is possible. We are looking forward to your application.