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This is a temporary contractor opportunity at Novartis Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life! Novartis partners with external managed service provider Magnit Global to offer engaging temporary contractor opportunities like this, to those who are looking for flexibility in their career while looking to gain new skills and experiences providing services to an inclusive global medicines company. Click here to learn more about Magnit. Ready to work with/through Magnit at Novartis? Please read on…
Summary
As Drug Product Project Leader you will be the strategic lead of complex (e.g. new modalities or late stage) Drug Product Development within Biologics projects and be accountable for agreed upon deliverables to the CMC team.
Major Accountabilities
* Lead and co-ordinate the global drug product sub-team (functional experts from e.g. Formulation and Process Development, Analytics, Production, Devices or Regulatory) and represent Drug Product Development on the global CMC team.
* Ensure adherence to the scientific and project review process and through relevant scientific and project management governance boards You ensure creation of high quality and scientific sound DP development documents enabling a strong CMC submission package and act as author, reviewer or approver role for development documents in accordance to the operational procedures and guidelines.
* Author or review regulatory CMC documents, contribute to the generation of filing dossiers, answer DP related questions in inspections and support Health Authority requests.
* 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 manage key scientific initiatives to develop short & long term drug product development strategies for a large NBE pipeline within global drug product 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.
What you’ll bring to the role
* Ph.D. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Technology, or equivalent.
* Minimum of 5 years of successful experience in biotech / pharma industry with emphasis on biologics drug product formulation and process development, manufacturing, scale-up, and technology transfer.
* Experience in protein analytics, lyophilization, primary 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 ability to work in cross-functional, international teams.
* Strong project management skills, ability to solve complex problems in a matrix system with excellent communication and negotiation skills.
* Strong presentation skills and scientific/technical writing skills.
Workload
100% (40 hours per week)
Role type
Onsite
Required start date
October 2025
Contract
24 months
Why Novartis
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?
EEO Statement
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accommodation
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at directsourceproteam@prounlimited.com.
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