Drug Product Project Leader - Associate Director (80-100%)
Inseriert am: 21.07.2021
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Job ID 322566BR Position Title Drug Product Project Leader - Associate Director (80-100%) Apply to Job
Job Description
300 ongoing clinical trials! That is the number of trials currently in Global Drug Development!
As associate director, you will play a key role in the development of formulations and processes for parenteral dosage forms of Biologics (e.g. monoclonal antibodies, therapeutic proteins, conjugates and other new modalities) for clinical or commercial use.
Working in an international team at our headquarters in Basel, Switzerland and help to bring innovative treatments to patients and global markets around the word. Apply now to join our diverse team!
Your responsibilities:
• As Drug Product Project Leader you'll be the lead of complex (e.g. new modalities or late stage) Drug Product Development within Biologics projects and be accountable for agreed upon results to the CMC team
• Lead and co-ordinate the drug product sub-team and represent Drug Development on the global CMC team.
• Author or review regulatory CMC documents and connect with health authorities, if required
• Coordinate and contribute to design, planning, performance and interpretation of scientific experiments for the pharmaceutical development of stable liquid and lyophilisate formulations, robust manufacturing processes of syringes, cartridges, vials and other presentations, characterization of formulation and process; upscale and transfer of processes and support if process validation and registration of the product
• Responsible for resource and budget planning of drug product development activities internally and externally. Proactively communicate project strategy and resource demand. Adapt project strategy and prioritize project activities as needed.
• You will lead and run key scientific initiatives to develop short & long term drug product development strategies for a large NBE pipeline within global drug development
• You will provide guidance to junior drug product development scientists and project leaders globally ensuring project management and scientific excellence within the organization.
• You will be working in multidisciplinary and international teams, reporting scientific/technical results internally and representing Novartis externally at meetings, giving talks, being part of industry consortiums, publishing papers.
Minimum requirements
What you’ll bring to the role:
• Ph.D. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Technology, or equivalent
• Proven experience in biotech / pharma industry with emphasis on biologics drug product development, manufacturing, scale-up, and technology transfer
• Experience in protein analytics, lyophilization, packaging development for biologics as well as BLA / MAA submission is an advantage.
• Proven track record in resolving technical issues as well as in the successful leadership of strategic innovation projects.
• Excellent scientific leadership skills, interdisciplinary thinking and proven track record to work in cross-functional, international teams.
• Strong presentation skills and scientific/technical writing skills.
Some restrictions on flexible working options may apply and will be discussed during interview if applicable.
Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. 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.
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:
talentnetwork.novartis.com/network Division Global Drug Development Business Unit TECHNICAL R & D GDD Location Switzerland Site Basel Company/Legal Entity Novartis Pharma AG Functional Area Research & Development Job Type Full Time Employment Type Regular Shift Work No
