The TRD Formulation Project Leader creates and drives with scientific & technological excellence the formulation development and manufacturing of inhalation, parenteral, topical and ophthalmic dosage forms in close collaboration with operations, analytics, particle engeeniring and biopharmaceutical experts, QA and the project DPPL.
Major activities are: 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.
**Your key responsibilities**:
Your responsibilities include, but are not limited to:
- Serve as line function representative in cross-functional project teams.
- Assists in the planning and execution of assigned projects while adhering to budget, scope and schedule requirements.
- Helps ensure consistent practices throughout all phases of the project life cycle.
- Lead the development of formulations and manufacturing processes of Drug Products.
- Lead the development and the qualification of analytical methods together with the AS&T team leader in accordance with ICHs guidelines and internal SOPs.
- Executes high quality, integrated cross-functional plans for projects.
- Participate to the transfer of analytical and manufacturing procedures to the Technical Operations.
- Prepares technical reports, summaries, protocols and quantitative analyses.
- Draft the CMC documents required for enabling regulatory submissions (IND/IMPD, Module3/NDA).
- Proactively communicates overall project strategy, key issues and any other critical topics in a timely manner to the appropriate management level, to the TRD Drug Product project leader and/ or to any other relevant project team member(s).
- Guide the internal discussions during the projects alignment.
**Commitment to Diversity & Inclusion**:
- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Minimum requirements**
**What you'll bring to the role**:
- PhD in Pharmaceutics or related sciences with a minimum of 3 years of relevant experience within the pharmaceutical/biotech industry or a Master's degree with a minimum of 5 years experience.
- Demonstrated success in developing formulations.
- Technical expertise and thorough understanding of drug product production and control technologies.
- Experience in writing CMC documents for regulatory submissions and responding to health authority questions.
- Good overall knowledge of GxP.
- Fluent in English.
Proficient in Italian.
Work location: Colleretto Giacosa (TO).
**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 here at Novartis!
**Imagine what you could do at Novartis!
**
**Division**
Oncology
**Business Unit**
ADVANCED ACCELERATOR APPLICATIONS
**Country**
Italy
**Work Location**
Colleretto Giacosa
**Company/Legal Entity**
AAA Italy Srl.
**Functional Area**
Research & Development
**Job Type**
Full Time
**Employment Type**
Regular
**Shift Work**
No
**Early Talent**
Yes