Analytical Project Leader (APL) (m/f), Schaftenau, Austria
>200! This the current number of programs in clinical development at Novartis. Many of these projects, which include new molecular entities as well as additional indications and different formulations for marketed products, are for medicines that could significantly advance treatment standards for patients worldwide. We are looking for you as an experienced Analytical project leader to join our team in Schaftenau to support development of these projects.
Your responsibilities include, but not limited to:
• You will lead and coordinate the analytical sub-team and represent analytic in the global CMC project team of assigned projects.
• You are accountable for managing all analytic related activities of Drug Product and Drug Substance development incl. release and stability-testing, characterization of the API, method-development, -transfer and -validation, specification setting, know-how transfer etc.
• You will need to communicate effectively across organizational interfaces i.e. project-/program-management; line functions etc.
• You will proactively identify scientific, technological and GMP issues, propose creative solutions and communicate key issues to the appropriate management level
• You are responsible for high quality analytical registration documents for HA submissions and you will Interact with authorities, act as technical expert in audits, inspections etc.
• You will actively contribute to budget and resource planning
What you'll bring to the role:
• PhD and 5 years relevant experience of Biologics CMC development
• Previous experience in analytical areas in biologic drug development in an industrial setting
• Proven leader with experience in managing teams
• Demonstrated excellent communication, presentation and management skills
• Excellent understanding of regulatory expectations and requirements
• Worked in interdisciplinary teams with excellent theoretical and scientific knowledge of product development
• Proven track record of creativity, problem solving and productivity
• Proficient scientific/technical writing skills
• Fluent in English (oral and written)
• Skills in German are welcome
Contact: Jennifer Kriedemann, Talent Acquisition & Staffing Business Partner 0044 7525 702920
Why consider Novartis?
750 million. That's how many lives our products touch. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.
We offer a market-competitive base salary in line with your qualification, experience and individual competencies. Additionally we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning & development options and worldwide career opportunities within the Novartis group. The base pay is composed of a market oriented excess payment and the respective amount according to the Austrian collective agreement (at least EUR 50,374.38 per year on a full time basis).
We are Novartis. Join us and help us reimagine medicine.
Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.
6250 Kundl, Austria