Senior Expert Device Project Leader Combination Product Portfolio (80-100)
Job Location:
Basel - Switzerland
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
Salary Range:
CHF93800.00 - CHF174200.00Band
Level 4Job Description Summary
Location: Basel Switzerland Schaftenau Austria#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.
Job Description
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-qualityif necessary adequate documentation up toDesign History File in case ofthe product is a combination productfor 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 engineeringpharmaceutical fieldor equivalent.
Minimum2-4yearsofexperience inthepharmaceutical industry preferablywith experience exposureto C> and RLT andtodrug-devicecombination producttechnicaldevelopmentincludingtechnical operations.
Ability to work and lead a cross-functional team in a matrix environment
Proven knowledgeand track recordinproject and program planning and execution
Understanding and awareness of regulatory guidelines fordrug-devicecombination products including relevant ISOs andcurrent good manufacturing practices(cGMP).
Collaborative spirit self-driven attitude high level of learning agilitygoodlistening skills strategicthinker.
Fluent in English (oral and writing) German is beneficial
Benefits & Rewards
At Novartis were committed to reimagining medicine together - and rewarding the people who make it happen.
Expected Annual Base Salary Range for role:Add: CHF 93800 toCHF 174200
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 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. Ifbecause of a medical condition or disability you need a reasonable accommodation for any part of therecruitment process or in order to receive more detailed information about the essential functions of aposition please send an e-mail to and let us know the nature ofyour request and your contact information. Please include the job requisition number in your message.
Barrierefreiheit und ZugänglichkeitWenn Sie aufgrund einer Erkrankung oder Behinderung spezielle Unterstützung während desRekrutierungsprozesses brauchen und/oder deswegen detailliertere Informationen über die wesentlichenFunktionen einer Stelle benötigen senden Sie bitte eine E-Mail an
und teilen Sie uns die Art Ihres Anliegens und IhreKontaktinformationen mit. Bitte vergessen Sie nicht dabei die Referenznummer der Stellenausschreibunganzugeben
Skills Desired
Data Science Materials Science Process Simulation Technical Writing Waterfall ModelRequired Experience:
Senior IC
About Company
Novartis is a global healthcare company based in Switzerland that provides solutions to the evolving needs of patients worldwide.
