Novartis AG
Senior Expert - Device Project Leader - Combination Product Portfolio (80-100%)
Summary
#LI-Hybrid
With the increasing diversity of Novartis' portfolio, the need for driving our device portfolio is also increasing. As such, we are searching for a Senior Expert – Device Project Leader for joining our team in Basel or Schaftenau in the Portfolio & Customer Center within Global Device and Packaging Development.
Job Description
In the role of Senior Expert – Device Project Leader, you will be a vital part of the Portfolio & Customer Center within the Global Device and Packaging Development (GDPD) team based in Basel /CH or Schaftenau/AT. Your primary responsibility is to guide and manage cross-functional project teams both within and outside of the GDPD. This includes representing GDPD in the CMC sub-teams, leading relevant discussions, gaining support, and securing approval for project strategy and changes with the primary focus on the Cell & Gene Therapy (C>) and Radioligand Therapy.(RLT) projects.
About the Role
Your responsibilities include but are not limited to:
- Represent GDPD in CMC sub-teams, leading device-related discussions and securing endorsement for project strategy or changes.
- Lead cross-functional project teams, acting as a single point of contact (SPOC) for all device and packaging related issues.
- Plan, manage, and control project resources, schedules, and budgets.
- Assess and negotiate internal & external resource needs on an ongoing basis. Establish and maintain a high-quality if necessary adequate documentation up to Design History File, in case of the product is a combination product for developments and LCM projects until transfer to manufacturing sites.
- Ensure compliance with internal process requirements and current regulations, including Design Control, CMC, FDA combination product regulations and ISO requirements.
- Contribute to the improvement of process and delivery technology approaches.
- Evaluate suitable device technology to support different project phases.
- Support internal and external audits on packaging and medical device related matters.
- Assist teams in regulatory dossiers preparation, including documents for medical device/combination product registration and in responding to health authority queries.
Essential Requirements:
- Master or PhD (preferred) in natural science, engineering, pharmaceutical field or equivalent.
- Minimum 2-4 years of experience in the pharmaceutical industry, preferably with experience exposure to C> and RLT and to drug-device combination product technical development including technical operations.
- Ability to work and lead a cross-functional team in a matrix environment
- Proven knowledge and track record in project and program planning and execution
- Understanding and awareness of regulatory guidelines for drug-device combination products, including relevant ISOs and current good manufacturing practices (cGMP).
- Collaborative spirit, self-driven attitude, high level of learning agility, good listening skills, strategic thinker.
- Fluent in English (oral and writing), German is beneficial
Benefits & Rewards
At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.
Expected Annual Base Salary Range for role: Add: CHF 93,800 to CHF 174,200
The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.
In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.
The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to E-Mail schreiben and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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E-Mail schreiben und teilen Sie uns die Art Ihres Anliegens und Ihre Kontaktinformationen mit. Bitte vergessen Sie nicht, dabei die Referenznummer der Stellenausschreibung anzugeben
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? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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