Rlt Formulation Project Leader (M/F/D)

Location: Italy
Role Purpose:
Create and drive with scientific & technological excellence the formulation development in close collaboration with operations, analytics, engineering and relevant SMEs, QA and the project DPPL. Development activities includes among others: formulation and process-design, control strategy, quality risk management, authoring of development documents and manufacturing instructions for technical and GMP manufacture incl. handling of deviation.
Role Responsibilities:
• Lead the development of formulations and manufacturing processes of Drug Products
• Support the development and the qualification of analytical methods together with the AS&T team leader in accordance with ICHs guidelines and internal SOPs. Participate as formulation expert to cross-functional project teams.
• Be accountable for all formulation and manufacturing process deliverables incl. scientific documentation for all assigned projects (Manufacturing instructions, GMP documents, deviation..).
• Guarantee technical support answering DP related questions in inspections and Health Authority requests throughout all phases of the project life cycle.
• Participate to the transfer manufacturing procedures to the relevant department (e.g. Technical Operations, CDMO, etc.).
• Ensure authoring of accurate, comprehensible, structured, complete and legible documents to allow timely start of development trials, process transfers and supply activities.
• Draft the CMC documents required to enable regulatory submissions (IND/IMPD, Module3/NDA).
• Provide technical guidance to team members and work according to appropriate SOPs, GLP, GMP, HSE and AdAcAp / Novartis guidelines.
• Proactively communicate key issues and any other critical topic in a timely manner to the appropriate management level, to the TRD DPPL and/or to any other relevant project team member.

Essential Requirements:
• Minimum: PhD in Pharmaceutics or related sciences with a minimum of 3 years of proven experience within the pharmaceutical/biotech industry or a Master’s degree with a minimum of 5 years experience.
• Fluent knowledge of English (oral and written). Desirable knowledge of site language.
• Demonstrated success in developing formulations with an emphasis in liquid sterile dosage forms.
• Technical expertise and detailed understanding of drug product production and control technologies.
• Experience with outsourcing and supervising work done by CRO/CMOs including technical overview of agreement set up.
• Experience in writing CMC documents for regulatory submissions and responding to health authority questions.
• Good basis of Quality Assurance (overall knowledge of GxPs).
Why Advanced Accelerator Applications?
Thousands of people die of cancer around the world every day. 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. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment 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!
Imagine what you could do at Novartis!
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