Rlt Formulation Project Leader
2 settimane fa
**Summary**:
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.
**About the Role**:
**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).
**Work Experience**:
- Functional Breadth.
- Operations Management and Execution.
- Collaborating across boundaries.
**Skills**:
- Environment.
- Experiments Design.
- Health And Safety (Ehs).
- Laboratory Equipment.
- Manufacturing Process.
- Materials Science.
- Process Simulation.
- Project Management.
- Sop (Standard Operating Procedure).
- Technical Writing.
**Languages**:
- English.
Division
International
Business Unit
Innovative Medicines
Location
Italy
Site
Ivrea
Company / Legal Entity
IT58 (FCRS = IT058) Advanced Accelerator Applications Italy Srl
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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