Senior Expert - Device Project Leader - Combination Product Portfolio (80-100%)

ppbSalary Range: /b /p pCHF93,800.00 - CHF174,200.00 /p h3Job Description Summary /h3 pLocation: Basel, Switzerland, Schaftenau, Austria, /p p#LI-Hybrid /p pWith 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. /p h3Job Description /h3 pIn 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. /p pYour responsibilities include but are not limited to: /p ul liRepresent GDPD in CMC sub-teams, leading device-related discussions and securing endorsement for project strategy or changes. /li liLead cross-functional project teams, acting as a single point of contact (SPOC) for all device and packaging related issues. /li liPlan, manage, and control project resources, schedules, and budgets. /li liAssess 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. /li liEnsure compliance with internal process requirements and current regulations, including Design Control, CMC, FDA combination product regulations and ISO requirements. /li liContribute to the improvement of process and delivery technology approaches. /li liEvaluate suitable device technology to support different project phases. /li liSupport internal and external audits on packaging and medical device related matters. /li liAssist teams in regulatory dossiers preparation, including documents for medical device/combination product registration and in responding to health authority queries. /li /ul h3Essential Requirements /h3 ul liMaster or PhD (preferred) in natural science, engineering, pharmaceutical field or equivalent. /li liMinimum 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. /li liAbility to work and lead a cross-functional team in a matrix environment. /li liProven knowledge and track record in project and program planning and execution. /li liUnderstanding and awareness of regulatory guidelines for drug-device combination product s, including relevant ISOs and current good manufacturing practice s (cGMP). /li liCollaborative spirit, self-driven attitude, high level of learning agility, good listening skills, strategic thinker. /li liFluent in English (oral and writing), German is beneficial. /li /ul h3Benefits Rewards /h3 pAt Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen. /p pExpected Annual Base Salary Range for role: CHF 93,800 to CHF 174,200. /p pThe 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. /p pIn addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. /p pThe 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. /p pAccessibility and accommodation /p pNovartis 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 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. /p pBarrierefreiheit und ZugänglichkeitWenn Sie aufgrund einer Erkrankung oder Behinderung spezielle Unterstützung während des Rekrutierungsprozesses brauchen und/oder deswegen detailliertere Informationen über die wesentlichen Funktionen einer Stelle benötigen, senden Sie bitte eine E-Mail an und teilen Sie uns die Art Ihres Anliegens und Ihre Kontaktinformationen mit. Bitte vergessen Sie nicht, dabei die Referenznummer der Stellenausschreibung anzugeben /p h3Skills Desired /h3 pData Science, Materials Science, Process Simulation, Technical Writing, Waterfall Model /p /p #J-18808-Ljbffr