Advanced Radiopharmaceutical Development Leader
1 giorno fa
**Mission and Vision**: At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. Our vision is to be on the cutting edge of medicine by combining medical science and digital innovation.
**Job Overview**: We are seeking an experienced Advanced Radiopharmaceutical Development Leader to lead and manage all Drug Product (DP) project activities linked to the development of radiopharmaceutical parenterals. The ideal candidate will have a strong background in pharmaceutical sciences, excellent knowledge of laboratory and/or technical tools, and experience with outsourcing and supervising work done by CRO/CMOs.
**Responsibilities**:
- Lead and manage all formulation and process development activities for assigned projects.
- Support the development and qualification of analytical methods together with the AS&T team leader in accordance with ICHs guidelines and internal SOPs.
- Represent DP project teams in TRD sub-team, with strong sense of accountability and responsibility.
- Develop sound DP project strategy including contingency planning and risk assessments in line with the overall TRD project plan, development guidelines (as applicable), SOPs and TRD/RLT strategy.
- Monitor project plans and ensure timely availability of agreed deliverables.
**Requirements**:
- PhD in Pharmaceutics or related sciences with a minimum of 6 years of proven experience within the pharmaceutical/biotech industry or a Master's degree with a minimum of 8 years experience.
- Fluent knowledge of English (oral and written).
- Broad and profound understanding of development activities and processes in pharmaceutical sciences.
- Excellent knowledge of laboratory and/or technical tools (e.g. Quality by Design, statistical software, Process Analytical Technology).
- Strong experience with outsourcing and supervising work done by CRO/CMOs including technical overview of agreement set up.
- Strong experience in writing CMC documents for regulatory submissions and responding to health authority questions.
- Solid understanding of relevant GLP, GMP regulations and policies.
**Compensation**: The estimated annual salary for this position is approximately €100,000 - €130,000 depending on qualifications and experience.
**Benefits**: As a member of the Advanced Accelerator Applications team, you will enjoy a comprehensive benefits package that includes a competitive salary, health insurance, pension plan, and opportunities for professional growth and development.
**Why Advanced Accelerator Applications?**: Thousands of people die of cancer around the world every day. Our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. By joining our team, you will be part of a dynamic and innovative environment that values diversity, equity, and inclusion. We believe that new groundbreaking solutions can be found at the intersection of medical science and digital innovation. Join us and help shape the future of medicine
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