Radiopharmaceutical Product Development Lead
3 settimane fa
Job Summary
We are seeking a highly skilled Radiopharmaceutical Product Development Lead to join our team at Innovative Medicines. As a key member of our organization, you will be responsible for leading and managing all Drug Product (DP) project activities linked to the development of radiopharmaceutical parenterals.
About the Role
The successful candidate will have a strong background in pharmaceutical sciences and experience in leading cross-functional teams. You will be responsible for designing, planning, performing, interpreting, and reporting the results of scientific experiments for the preparation and timely delivery of drug product.
Key Responsibilities
• Leads and manages all formulation and process development activities for assigned projects.
• Supports the development and qualification of analytical methods together with the AS&T team leader in accordance with ICH guidelines and internal SOPs.
• Represents DP project teams in TRD sub-team, with strong sense of accountability and responsibility.
• Develops 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.
• Monitors project plans and ensures timely availability of agreed deliverables.
• Proactively communicates overall project strategy, key issues, and any other critical topics in a timely manner to the appropriate management level, to the TRD project leader and/or to any other relevant project team member(s).
• Ensures adherence to the EP/LP project review process through relevant governance boards.
• Ensures high quality documentation and pre-reads are provided per guidelines to facilitate these reviews.
• Ensures support to due diligence as applicable.
• Ensures availability of pre-requisites for transfer of projects to other sites as applicable (e.g. licenses, equipment, resource plan).
• Ensures application of IP process for all projects assigned and that all IP is accurately captured.
• Ensures contribution to respective Network deliverables and cross-functional workstreams/initiatives and ensure sharing of actions and learnings across global teams.
Requirements
• Minimum: 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).
• Desirable knowledge of site language.
• 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.
• Strong presentation skills and scientific/technical writing skills.
About Us
At Innovative Medicines, we are committed to transforming lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. We are a diverse, equitable and inclusive environment that inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying.
Join Our Team
If you are a motivated and experienced professional looking for a new challenge, please submit your application. We look forward to hearing from you
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